| 23 Dec 2014 | Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 17 Dec 2014 | Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4. Event 69985 | Neolpharma, Inc. | Drug | Class II | 1 |
| 15 Dec 2014 | Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9 Event 68944 | Tricar Sales Inc | Food | Class II | 1 |
| 9 Dec 2014 | sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7 Event 69977 | J. Strickland and Co | Drug | Class III | 1 |
| 8 Dec 2014 | White Tahina, Net Wt. 907 g, 12 jars/case Event 69973 | Name withheld | Food | Class I | 1 |
| 5 Dec 2014 | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 | Sandoz Incorporated | Drug | Class III | 1 |
| 5 Dec 2014 | BELVIQ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960. Event 69959 | Eisai Inc | Drug | Class III | 1 |
| 5 Dec 2014 | WHALEN'S SEAFOOD & BURGER SAUCE "HOT", NET WT. 8 OZ. (226 g) -- Whalen's Horseradish Products, LLC, PO Box 4700, Saratoga Springs, New York 12866 Event 69966 | Whalen's Horseradish Products | Food | Class II | 1 |
| 4 Dec 2014 | Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile | Baxter Corporation Englewood | Device | Class II | 1 |
| 4 Dec 2014 | Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach… | Zimmer, Inc. | Device | Class II | 1 |
| 4 Dec 2014 | Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its… | Zimmer Manufacturing B.V. | Device | Class II | 1 |
| 4 Dec 2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equaline, DISTRIBUTED… | K C Pharmaceuticals Inc | Drug | Class III | 4 |
| 4 Dec 2014 | Willy's Just Peachy Salsa, packaged in 16-oz. plastic deli containers Event 69953 | Willy's Inc | Food | Class II | 1 |
| 3 Dec 2014 | GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing,… Event 69930 | Leonhard Lang Gmbh | Device | Class I | 1 |
| 3 Dec 2014 | WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. | Teleflex Medical | Device | Class II | 1 |
| 3 Dec 2014 | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in… | Iris Diagnostics | Device | Class II | 1 |
| 3 Dec 2014 | Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. | Pfizer Inc. | Drug | Class II | 1 |
| 3 Dec 2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61 | Hospira Inc. | Drug | Class II | 1 |
| 2 Dec 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0. | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 2 Dec 2014 | Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision… | Biomet, Inc. | Device | Class II | 2 |
| 2 Dec 2014 | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA | Zimmer Trabecular Metal Technology, Inc. | Device | Class II | 1 |
| 2 Dec 2014 | Dark Cocoa Sorbetto packed in 14 oz. plastic jars, 8 packages per case, manufactured from 4/11/14-4/12/14; product code: EB/JP, L3, 26-426, 14102, BEST BY October 12, 2015, BEST BY 10/15. | House Of Flavors, Inc. | Food | Class I | 1 |
| 1 Dec 2014 | Pea River Raw Shelled Raw Fine Alabama Grown Peanuts, Net Wt. 2.5 lbs Event 69958 | Pea River Peanut Company, LLC | Food | Class II | 1 |
| 1 Dec 2014 | Shelled Peanuts, in bulk Event 69923 | Sessions Co. Inc. | Food | Class II | 1 |
| 29 Nov 2014 | Whole Foods Tarte Aux Pomme 10 inch, packaged in a brown box. Net Wt. 2 lb 8 oz. UPC: 23072300000 | Whole Food Market | Food | Class I | 1 |
| 26 Nov 2014 | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for… | Getinge Disinfection Ab | Device | Class II | 1 |
| 26 Nov 2014 | Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 26 Nov 2014 | Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699. | Whole Food Market | Food | Class I | 1 |
| 25 Nov 2014 | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and… | Carestream Health Inc | Device | Class II | 1 |
| 25 Nov 2014 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 25 Nov 2014 | Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22. | Hospira Inc. | Drug | Class III | 1 |
| 24 Nov 2014 | DASANI (R) PURIFIED WATER, 16.9 FL OZ (1.06 PT) 500 mL, BOTTLED BY A MEMBER OF THE COCA-COLA BOTTLERS' ASSOCIATION, ATLANTA, GA 30313, UPC 24pk- 2 4900003165 2 Event 69850 | Coca Cola Bottling Company United, LLC | Food | Class III | 1 |
| 24 Nov 2014 | Private Selection Extreme Moose Tracks Ice Cream; packaged in plastic 48 fl oz containers, UPC Code: 11110-00456 | The Kroger Co | Food | Class I | 1 |
| 24 Nov 2014 | HyVee Cheddar Cheese Stuffed Jalapenos. Product is breaded jalapeno stuffed with cheddar cheese designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 ounces, and packed 12 units per case.… | Great American Appetizers, Inc. | Food | Class I | 1 |
| 21 Nov 2014 | Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular… | Zimmer Manufacturing B.V. | Device | Class II | 1 |
| 21 Nov 2014 | TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) | TomoTherapy Incorporated | Device | Class II | 1 |
| 21 Nov 2014 | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for… | Instrumentation Laboratory Co. | Device | Class II | 1 |
| 21 Nov 2014 | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 21 Nov 2014 | KOZY SHACK SIMPLY WELL CHOCOLATE, NET WT 4 OZ. Product packed in brown carton box, 48 individual units x 4 OZ. Keep Refrigerated. Made in USA Event 69822 | Kozy Shack Inc | Food | Class II | 1 |
| 20 Nov 2014 | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. | Boston Scientific Corp | Device | Class II | 1 |
| 20 Nov 2014 | UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Event 69856 | Unistrip Technologies LLC | Device | Class II | 1 |
| 20 Nov 2014 | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures. | Cyberonics, Inc | Device | Class II | 1 |
| 20 Nov 2014 | Wake-Up Instant Coffee Mix (weasel coffee) Melange de Cafe Instantane Ca Phe Hoa Tan (huong caon) 3 in one; sold in two packing configurations: 1. 20 bags x (0.6 oz) 17g in Plastic Bag 2. 18 bags x (0.6 oz) 17g in Paper Box. Original ingredient statement: Non-Dairy Creamer, Sugar, instant Coffee, Maltodextrin,… | Evershing International Trading Inc. | Food | Class I | 1 |
| 19 Nov 2014 | Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability. | ConforMIS, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology… | Horiba Instruments Inc | Device | Class II | 1 |
| 19 Nov 2014 | Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. | Natus Medical Incorporated | Device | Class II | 1 |
| 19 Nov 2014 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21 | American Health Packaging | Drug | Class II | 1 |
| 18 Nov 2014 | Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2 samples of a second product not being recalled. The product comes in small plastic container with lid (3.5" x 2.5" x 21.875"). A small spoon is also present in the package. Gift… Event 69848 | Tastefully Simple, Inc | Food | Class III | 1 |
| 17 Nov 2014 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum. | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Device | Class III | 1 |
| 17 Nov 2014 | PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco,… | Name withheld | Device | Class II | 207 |
| 17 Nov 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space. | Halyard Health | Device | Class I | 5 |
| 17 Nov 2014 | Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box). | Karlsburger Foods, Inc. | Food | Class I | 2 |
| 17 Nov 2014 | Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. Dallas, TX 75218, www.CheesecakeRoyale.com | Cheesecake Royale, Inc. | Food | Class II | 4 |
| 14 Nov 2014 | MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7. Event 69779 | Name withheld | Drug | Class II | 1 |
| 14 Nov 2014 | Mozzarella cheese sticks are breaded Mozzarella Stick designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 oz., and there are 12 units per case. Product is sold under brand HyVee and has… | Great American Appetizers, Inc. | Food | Class II | 1 |
| 14 Nov 2014 | Houdini, 3 oz Honey Mustard Pretzel Nuggets, item # COM 562 | Baptista's Bakery, Inc | Food | Class I | 1 |
| 14 Nov 2014 | SOLGAR ENHANCED SERIES ABC DOPHILUS POWDER FOR INFANTS AND CHILDREN, NET WT. 1.75 oz (50 g), UPC 0 33984 00010 0. Carefully Manufactured by: Solgar, Inc., 500 Willow Tree Road Leonia, NJ 07605 U.S.A. | NBTY, Inc. | Food | Class I | 1 |
| 14 Nov 2014 | Taco Seasoning Packets sold under the following brands, container size, and or as part of a dinner Kit: 1. Ortega 1.25 oz, UPC 39000-00820; 2. Ortega 3-pack, 3.75 oz. UPC 39000-00821; 3. Ortega Foodservice 5 lb. UPC 39000-00860 and 9 oz. 39000-00861; 4. Las Palmas 3-pack 3.75 oz. UPC 41501-79811 and (Canada) 106 g.… | B&G Foods North America, Inc | Food | Class I | 7 |
| 14 Nov 2014 | Organic Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 6) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw.… | Wehah Farms | Food | Class I | 2 |
| 13 Nov 2014 | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella. | Remel Inc | Device | Class II | 1 |
| 13 Nov 2014 | Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA Inc. | Device | Class II | 5 |
| 13 Nov 2014 | Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte… | Illumina Inc | Device | Class II | 1 |
| 12 Nov 2014 | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management. | Teleflex Medical | Device | Class II | 1 |
| 12 Nov 2014 | GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 12 Nov 2014 | Beachbody Hardcore Base Shake Lot #42932B22, #42931A22, and #42902B22 Black HDPE container with Black Lid. Label stated weight of 1 lb. 12.2 oz. (800 g.) Lot code information located on the bottom of the container in yellow ink. Event 69772 | Beachbody Llc | Food | Class II | 1 |
| 11 Nov 2014 | Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Nov 2014 | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. | Aesculap, Inc. | Device | Class III | 1 |
| 11 Nov 2014 | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery. | Alcon Research, Ltd. | Device | Class II | 1 |
| 11 Nov 2014 | Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and… Event 69737 | Cure Medical LLC | Device | Class II | 1 |
| 11 Nov 2014 | Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. | Ebi, Llc | Device | Class II | 1 |
| 11 Nov 2014 | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use. | Heart Sync, Inc. | Device | Class I | 5 |
| 11 Nov 2014 | HeartLight Seafood brand Frozen Yellowfin Tuna Ground Meat (Thunnus albacares), IQF packed in a master carton of 10 x 1 lbs HDPE bags Event 69749 | Heartlight Seafood LLC | Food | Class II | 1 |
| 10 Nov 2014 | Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Arrow International Inc | Device | Class II | 1 |
| 10 Nov 2014 | MEVION S250, used for proton radiation therapy. | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 10 Nov 2014 | GE Cabinet X-ray systems | GE Inspection Technologies, LP | Device | Class II | 1 |
| 10 Nov 2014 | Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 9 Nov 2014 | IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 7 Nov 2014 | Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 7 Nov 2014 | adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 7 Nov 2014 | Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX Complete Brain Probe… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 7 Nov 2014 | Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44 | Perry Drug Inc. | Drug | Class II | 17 |
| 7 Nov 2014 | Orejas- pastry containing soy, eggs, wheat and milk | Mexicantown Bakery, Inc | Food | Class I | 5 |
| 6 Nov 2014 | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml… | Abbott Medical Optics Inc (AMO) | Device | Class II | 1 |
| 6 Nov 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device. | ConMed Corporation | Device | Class I | 9 |
| 6 Nov 2014 | Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW | Integra LifeSciences Corp. | Device | Class II | 1 |
| 6 Nov 2014 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. | Illumina Inc | Device | Class III | 1 |
| 6 Nov 2014 | VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 6 Nov 2014 | "Everything Bagels" product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels. This product has the UPC number 7 17887 23121 1. The product is labeled in parts: "***Everything Bagels***Net Wt. 16 oz (1 lb) 454 g***Produced By Schwartz Brothers Bakery Seattle, Renton… | Schwartz Brothers Restaurants dba Schwartz Brothers Bakery | Food | Class II | 1 |
| 5 Nov 2014 | Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. | Gambro Renal Products Inc | Device | Class II | 2 |
| 5 Nov 2014 | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB… | Philips Ultrasound, Inc. | Device | Class II | 4 |
| 5 Nov 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of… | Toshiba American Medical Systems Inc | Device | Class II | 2 |
| 5 Nov 2014 | Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 5 Nov 2014 | Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 5 Nov 2014 | Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by 06/10/2016, UPC 207935110006 Event 69761 | SUSHI HOUSE INC. | Food | Class II | 1 |
| 5 Nov 2014 | Coca Cola Zero, 2 liter pet bottle, UPC 49000 05014, The Coca Cola Company | Coca-Cola Company (The) | Food | Class III | 1 |
| 4 Nov 2014 | LUNA Chest, Model No. LU4006 | Novadaq Technologies, Inc. | Device | Class III | 2 |
| 4 Nov 2014 | McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes Event 69805 | Aircraft Medical Limited | Device | Class II | 1 |
| 4 Nov 2014 | BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 4 Nov 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. | Smith & Nephew, Inc. | Device | Class II | 3 |
| 4 Nov 2014 | Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864,… | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 4 Nov 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY | Bausch & Lomb Inc | Device | Class II | 3 |
| 4 Nov 2014 | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 5 |
| 4 Nov 2014 | Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vinegar, Worcestershire Sauce, Onions and Spices, P.O. Box 22764, Hilton Head Island, SC 29925. | R and S Gourmet Warehouse | Food | Class II | 2 |
| 4 Nov 2014 | Alfalfa Seed in plastic lined bags labeled in part “*** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Specialty Supply *** | International Sprout Holding Inc. | Food | Class I | 1 |
| 3 Nov 2014 | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006. | Bard Access Systems | Device | Class II | 1 |
| 3 Nov 2014 | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. Event 69630 | Name withheld | Device | Class II | 1 |
| 3 Nov 2014 | 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | Intuitive Surgical, Inc. | Device | Class II | 22 |
| 31 Oct 2014 | The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a… | Medtronic Perfusion Systems | Device | Class II | 1 |
| 31 Oct 2014 | UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope. | US Endoscopy Group Inc | Device | Class II | 1 |
| 31 Oct 2014 | Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box. | Invacare Corporation | Device | Class II | 1 |
| 31 Oct 2014 | ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021 Packaging: For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sale: 6-packs of 1 liter bottles and as… Event 69716 | Nature's Way Purewater Systems, Inc. | Food | Class II | 1 |
| 30 Oct 2014 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. | Carestream Health, Inc. | Device | Class II | 1 |
| 30 Oct 2014 | INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750274, 8065750278, 8065750280, 8065750281,… | Alcon Research, Ltd. | Device | Class II | 1 |
| 30 Oct 2014 | Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 29 Oct 2014 | Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria. | Remel Inc | Device | Class II | 1 |
| 29 Oct 2014 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and… | Respironics California Inc | Device | Class II | 1 |
| 28 Oct 2014 | The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted… Event 69631 | Summit Industries Inc. | Device | Class II | 1 |
| 28 Oct 2014 | Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 28 Oct 2014 | Soft Contact Lens | Cooper Vision Caribbean Corp. | Device | Class II | 1 |
| 28 Oct 2014 | Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 86635 4… | Marathon Ventures Inc | Food | Class I | 1 |
| 27 Oct 2014 | Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic… | ArthroCare Medical Corporation | Device | Class II | 1 |
| 27 Oct 2014 | Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 27 Oct 2014 | CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract. | CooperSurgical, Inc. | Device | Class II | 1 |
| 27 Oct 2014 | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The… | CooperSurgical, Inc. | Device | Class III | 1 |
| 27 Oct 2014 | Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars. | Kent Precision Foods Group, Inc. | Food | Class II | 1 |
| 27 Oct 2014 | Alfalfa seed: Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty Supply | International Sprout Holding Inc. | Food | Class I | 1 |
| 24 Oct 2014 | Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM | AGFA Healthcare Corp. | Device | Class III | 1 |
| 24 Oct 2014 | Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits Event 69625 | Discus Dental LLC | Device | Class II | 1 |
| 24 Oct 2014 | The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus. | Aesculap, Inc. | Device | Class II | 1 |
| 24 Oct 2014 | Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25 | CareFusion 213, LLC | Drug | Class III | 1 |
| 24 Oct 2014 | Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01 | Hospira Inc. | Drug | Class II | 1 |
| 24 Oct 2014 | Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ | Tristar Food Wholesale Co Inc | Food | Class II | 1 |
| 24 Oct 2014 | Oceans Catch All Natural Jonah Crab Combo Meat, Packaged in round plastic containers (tub with snap-on lid), sold refrigerated: 6 ounce, 8 ounce, and 16 ounce | Rome Packing Co., Inc. | Food | Class I | 2 |
| 23 Oct 2014 | Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5). | Synthes (USA) Products LLC | Device | Class I | 1 |
| 23 Oct 2014 | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. | JAS Diagnostics Inc. | Device | Class II | 1 |
| 23 Oct 2014 | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate… | Remel Inc | Device | Class II | 2 |
| 23 Oct 2014 | Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. Event 69542 | Name withheld | Device | Class II | 1 |
| 23 Oct 2014 | Deep Raw Cashew Pieces Distributed by Chetak New York LLC Edison, NJ 08837 USA 7 oz. - UPC 011433133104 - 20 per case 14 oz. - UPC 011433133111 - 20 per case 28 oz. - UPC 011433133128 - 10 per case packaged in a plastic bag; for dry storage | Chetak New York, LLC | Food | Class I | 1 |
| 23 Oct 2014 | Odwalla Chocolate Protein Shake, 15.2 fl. oz, and 32 fl. oz bottles, Distributed by: Odwalla, Inc., Dinuba, CA 93618. | Coca-Cola Company (The) | Food | Class II | 2 |
| 22 Oct 2014 | GDC-10 360 SOFT 3mm x 6cm SR; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by… | Name withheld | Device | Class II | 5 |
| 22 Oct 2014 | Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411 | Premier Research Labs LP | Food | Class II | 2 |
| 21 Oct 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian… | Gyrus Acmi, Incorporated | Device | Class II | 1 |
| 21 Oct 2014 | Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 | Los Chileros De Nuevo Mexico, LTD | Food | Class II | 7 |
| 20 Oct 2014 | MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations. | Microgenics Corporation | Device | Class II | 1 |
| 20 Oct 2014 | Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage | Pfm Medical Inc | Device | Class II | 9 |
| 20 Oct 2014 | HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.… | Radiometer America Inc | Device | Class II | 1 |
| 17 Oct 2014 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to… | INO Therapeutics (dba Ikaria) | Device | Class II | 1 |
| 17 Oct 2014 | Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA. | Ethicon, Inc. | Device | Class II | 1 |
| 17 Oct 2014 | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | Biomet Microfixation, LLC | Device | Class II | 14 |
| 16 Oct 2014 | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and… | Materialise USA LLC | Device | Class II | 1 |
| 16 Oct 2014 | Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment.… Event 69580 | Name withheld | Device | Class II | 1 |
| 15 Oct 2014 | AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Event 69515 | Vision Rt Inc | Device | Class II | 1 |
| 15 Oct 2014 | AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle… | American Medical Systems, Inc. | Device | Class II | 2 |
| 14 Oct 2014 | Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. | Zimmer, Inc. | Device | Class II | 2 |
| 14 Oct 2014 | Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09. | Hospira Inc. | Drug | Class II | 11 |
| 14 Oct 2014 | Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141 | Vann Healthcare Services Inc | Drug | Class II | 4 |
| 10 Oct 2014 | Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body. | Philips Medical Systems, Inc. | Device | Class I | 1 |
| 10 Oct 2014 | Queso Seco Centroamericano (Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Centroamericano Dry White Cheese Net Wt 1LB (16oz) | Oasis Brands, Inc | Food | Class I | 16 |
| 9 Oct 2014 | BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is… | Becton Dickinson & Company | Device | Class II | 1 |
| 9 Oct 2014 | ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 8 Oct 2014 | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Customed, Inc | Device | Class I | 179 |
| 7 Oct 2014 | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | Mako Surgical Corporation | Device | Class II | 3 |
| 6 Oct 2014 | Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. Event 69784 | Name withheld | Device | Class II | 1 |
| 6 Oct 2014 | DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 2 Oct 2014 | candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92 | Sandoz, Inc | Drug | Class III | 1 |
| 1 Oct 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class I | 1 |
| 1 Oct 2014 | Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16 | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 30 Sep 2014 | Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 29 Sep 2014 | Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 29 Sep 2014 | Dharma Cavity Varnish with Fluoride | Dharma Research, Inc. | Device | Class II | 2 |
| 29 Sep 2014 | ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height Event 69662 | 4-Web Inc. | Device | Class II | 1 |
| 26 Sep 2014 | Amerigel Hydrogel Wound Dressing Wound management | Amerx Health Care Corp. | Device | Class II | 4 |
| 26 Sep 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6. | Actavis Laboratories, FL, Inc. | Drug | Class II | 1 |
| 26 Sep 2014 | Whole Foods Market Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base | Whole Food Market | Food | Class I | 1 |
| 24 Sep 2014 | BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01 | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 23 Sep 2014 | Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from… | Invacare Corporation | Device | Class II | 1 |
| 18 Sep 2014 | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum. Event 69621 | Biomerica | Device | Class II | 1 |
| 11 Sep 2014 | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer… | Abbott Ireland Diagnostics Division | Device | Class II | 1 |
| 11 Sep 2014 | HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03 | Hospira Inc. | Drug | Class I | 1 |
| 8 Sep 2014 | A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus. | Instrumed International, Inc. | Device | Class II | 28 |
| 5 Sep 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. | Pharmacy Creations | Drug | Class I | 4 |
| 4 Sep 2014 | Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. | GE Healthcare, LLC | Device | Class II | 3 |
| 3 Sep 2014 | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No.… | Teleflex Medical | Device | Class II | 2 |
| 22 Aug 2014 | Margaret Holmes Mixed Greens 14.5 oz, Distributed by McCall Farms, Effingham, SC | Mccall Farms Inc | Food | Class III | 2 |
| 19 Aug 2014 | MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561. | nSpired Natural Foods, Division of the Hain Celestial Group | Food | Class I | 25 |
| 11 Aug 2014 | Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for… Event 69835 | Instradent USA, Inc. | Device | Class II | 1 |
| 31 Jul 2014 | Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 23 Jul 2014 | Whole Foods Market Dip Peach Salsa, UPC/PLU 029648300000 Whole Foods Market Scale-Salsa Peach, UPC/PLU 96483 Whole Foods Market Peach Salsa MIN, UPC/PLU 96483 Whole Foods Market Peach Salsa XS, UPC/PLU 90614 Whole Foods Market Peach Salsa, UPC/PLU 25023900000 Whole Foods Market Dip Salsa Peach-LG, UPC/PLU 29648300000… | Whole Foods Market | Food | Class II | 75 |
| 20 Jul 2014 | Wegmans Peach Salsa, made fresh in-store and packaged in random weights. | Wegmans Food Markets, Inc. | Food | Class II | 10 |
| 18 Jul 2014 | Sweet 2 Eat Yellow Peaches; California Tree Fruit; Product of USA; Packed in the following configurations: 2.5 lb. box, 4-4.5 lb. box 4-4.5 lb box for Trader Joe's 8/2 Clamshell - net weight 2 lbs. Costco Consumer Box, 5 lbs Sam's Club consumer box - 4 lbs (Summer Flame) BJ's 4 lb clamshell 2 lb bag. Sticker… | Wawona Packing Company | Food | Class I | 6 |
| 16 Jul 2014 | Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades. Event 68745 | Market-Tiers Inc | Device | Class II | 1 |
| 12 May 2014 | Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01. | Kerry Foods | Food | Class I | 13 |
| 30 Apr 2014 | Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land marks. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 24 Apr 2014 | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 17 Apr 2014 | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . | Wockhardt Usa Inc. | Drug | Class III | 1 |
| 8 Apr 2014 | Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions.… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 1 Apr 2014 | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not… | ZOLL Circulation, Inc. | Device | Class II | 1 |
| 25 Mar 2014 | New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street… | New Life Nutritional Center | Drug | Class I | 3 |
| 13 Dec 2013 | Farmer Brand DRIED LILY FLOWERS, NET WT. 8 oz, UPC 7 34765 04089 5 -- PRODUCT OF CHINA -- DISTRIBUTED BY BLOOMING IMPORT 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- Nutrition Facts: Serving Size 0.4 oz. Servings Per Container 20 --- The product is packaged in a sealed flexible plastic bag. | Blooming Import Inc. | Food | Class I | 1 |
| 13 Nov 2013 | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen… | Concentric Medical Inc | Device | Class II | 1 |
| 23 Oct 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 26 Sep 2013 | Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. | Concentric Medical Inc | Device | Class II | 1 |
| 11 Sep 2013 | The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Aug 2013 | Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures. | Zimmer, Inc. | Device | Class II | 1 |
| 26 Aug 2013 | Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages… Event 69665 | Snug Seat Inc | Device | Class II | 1 |
| 19 Apr 2013 | Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the… | Ge Healthcare It | Device | Class II | 1 |
| 19 Mar 2013 | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and… | Hospira Inc. | Device | Class II | 2 |
| 5 Mar 2013 | 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and… | Name withheld | Device | Class II | 3 |
| 27 Sep 2012 | MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. | Fresenius Kabi USA, LLC | Drug | Class II | 3 |
| 18 Jul 2012 | Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925 | LNK International, Inc. | Drug | Class II | 1 |
| 13 May 2008 | Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide… | Beevers Manufacturing & Supply, Inc. | Device | Class II | 1 |
| 18 Jan 2007 | Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier… | Beevers Manufacturing & Supply, Inc. | Device | Class II | 1 |