| 14 Nov 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY | Akorn Inc | Drug | Class II | 1 |
| 9 Nov 2016 | Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771. | VistaPharm, Inc. | Drug | Class II | 1 |
| 9 Nov 2016 | L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Sandoz Inc | Drug | Class II | 2 |
| 9 Nov 2016 | Free2b Sun Cups Chocolate. Made With SunButter Sunflower Spread. Packaged in 2 Cups. Net weight 1.5 oz (45g) and 1 Cup. Net weight 0.75 oz (21g) (75667) | Seth Ellis Chocolatier, LLC | Food | Class I | 1 |
| 7 Nov 2016 | The Hemotherm 400CE 115v, containing power board p/n 39945 | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 7 Nov 2016 | LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01 | Pfizer Inc. | Drug | Class II | 1 |
| 4 Nov 2016 | Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01 | West-Ward Pharmaceuticals Corp. | Drug | Class III | 1 |
| 3 Nov 2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 2 Nov 2016 | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 2 Nov 2016 | Panera Bread Broccoli Cheddar Soup, 48 oz. sleeve (2/24 oz. cups/sleeve). Refrigerated UPC Code: 077958790918 | Blount Fine Foods Corporation | Food | Class III | 1 |
| 1 Nov 2016 | Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 1 Nov 2016 | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32 | Hospira Inc. | Drug | Class II | 1 |
| 31 Oct 2016 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 31 Oct 2016 | MEVION S250 Product Usage: Proton Radiation Therapy | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 28 Oct 2016 | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound | Hologic, Inc | Device | Class II | 1 |
| 28 Oct 2016 | KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8. | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 28 Oct 2016 | Simply Balanced brand White Chicken Chili dry soup mix. This is not a ready to eat product and it does not contain any chicken. It is packaged in a clear poly bag with print on front and back, Net WT. 10 oz.., UPC is 0 85239 18973 3. (75577) | Conifer Specialties, Inc. | Food | Class III | 1 |
| 27 Oct 2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories | Amerisource Health Services | Drug | Class III | 1 |
| 26 Oct 2016 | Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. | Atrium Medical Corporation | Device | Class II | 8 |
| 26 Oct 2016 | Stewart's SPORTADE FRUIT PUNCH Isotonic Beverage 20 Fl Oz (591 mL), UPC 0 82086 31006 8. The product is packaged in a plastic bottle, and has a black label with a red plastic cap. (75547) | STEWARTS SHOPS CORP | Food | Class I | 1 |
| 26 Oct 2016 | 10" Flour Tortillas 12 count, Net Wt. 25oz (732g) (75549) | Fanega Mexican Food Products, Inc. | Food | Class II | 1 |
| 25 Oct 2016 | ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU | Depuy Orthopaedics Inc. | Device | Class II | 1 |
| 25 Oct 2016 | Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 25 Oct 2016 | OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia… | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 24 Oct 2016 | Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. | Beckman Coulter Inc. | Device | Class II | 2 |
| 21 Oct 2016 | MEVION S250 Product Usage: Proton Radiation Therapy System | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 21 Oct 2016 | Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12. | Akorn Inc | Drug | Class II | 1 |
| 21 Oct 2016 | Three Way Popcorn Sampler that contains three types of popcorn (cheese, carmel and buttered popcorn) packed inside one unlabeled clear plastic bag, physically divided by a three-way paperboard divider. The bag is packed inside a metal tin. (75517) | JML Holdings Inc | Food | Class I | 1 |
| 21 Oct 2016 | Krispy Kreme Doughnuts Original Glazed Doughnuts, 6 count and 12 count boxes. | Krispy Kreme Doughnut Corporation | Food | Class III | 1 |
| 21 Oct 2016 | Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.) (75550) | Sokol and Co | Food | Class II | 1 |
| 20 Oct 2016 | MEVION S250 Product Usage: Proton Radiation Therapy System | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 20 Oct 2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05 | CutisPharma, Inc. | Drug | Class III | 2 |
| 20 Oct 2016 | HEARTLAND ENTREES DUMPLINGS AND BROTH, Product Code 856140, NET WEIGHT: (320 ozs)(9.09 kg)(4-5 Lbs), KEEP FROZEN | St Clair Foods, Inc. | Food | Class I | 1 |
| 20 Oct 2016 | Brownwood Farms Cherry Raspberry Preserves 12oz glass bottles and 1 gallon. | Brownwood Farms | Food | Class II | 6 |
| 19 Oct 2016 | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells. | Beckman Coulter Inc. | Device | Class II | 1 |
| 19 Oct 2016 | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 19 Oct 2016 | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 19 Oct 2016 | SOMATOM Definition AS system, x-ray, tomography, computed | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 19 Oct 2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01 | Sandoz Inc | Drug | Class III | 1 |
| 19 Oct 2016 | Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60 (75449) | Janssen Ortho L.L.C. | Drug | Class III | 1 |
| 18 Oct 2016 | Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 18 Oct 2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01 | GSK Consumer Healthcare | Drug | Class III | 1 |
| 18 Oct 2016 | Fruit 66 Mixed Berry, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients. UPC 98341-00117. | 1 Epic, LLC | Food | Class II | 4 |
| 14 Oct 2016 | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total… (75499) | OMNI LIFE SCIENCE | Device | Class III | 1 |
| 14 Oct 2016 | ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more… (75475) | Reshape Medical Inc | Device | Class II | 1 |
| 13 Oct 2016 | Brilliance iCT Computed Tomography X-ray system, Model 728306 | Philips Medical Systems (Cleveland) Inc | Device | Class III | 6 |
| 13 Oct 2016 | Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. | C.R. Bard, Inc. | Device | Class II | 4 |
| 13 Oct 2016 | AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 | Amerisource Health Services | Drug | Class III | 1 |
| 13 Oct 2016 | Bindi Fantasia nel dessert, 7982 Coconut Gran Sorbetto, 1.24 Gal (4.8L), UPC 8 15073 01326 6, Distributed by: Bindi North America, Kearny, NJ 07032 (75468) | Bindi North America | Food | Class I | 1 |
| 12 Oct 2016 | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests.… | Alere San Diego, Inc. | Device | Class II | 1 |
| 12 Oct 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc… | DePuy Spine, Inc. | Device | Class II | 7 |
| 12 Oct 2016 | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014. | C.R. Bard, Inc. | Device | Class II | 1 |
| 12 Oct 2016 | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in… | C.R. Bard, Inc. | Device | Class II | 1 |
| 12 Oct 2016 | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 12 Oct 2016 | Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65. | Pharmedium Services, LLC | Drug | Class II | 1 |
| 12 Oct 2016 | Nazook, Net Wt. 10 oz. (283g), UPC 7 80890 28606 6. | Nobel Bakery | Food | Class II | 15 |
| 11 Oct 2016 | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in… | Baylis Medical Corp * | Device | Class II | 1 |
| 11 Oct 2016 | RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U | Stryker Instruments Div. of Stryker Corporation | Device | Class III | 1 |
| 11 Oct 2016 | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma. | Abbott Laboratories | Device | Class II | 1 |
| 11 Oct 2016 | Roland¿ Preserved Lemons, NET WT. 12.35 OZ., and Roland¿ PRESERVED LEMONS - BELDI, NET WT. 13 OZ., Item UPC 4122461002 and Case UPC 10041224610023 -- PACKED EXCLUSIVELY FOR ROLAND FOODS LLC, NEW YORK, NY 10010 --- The product is packed in a glass jar. | Roland Foods, LLC. | Food | Class II | 1 |
| 11 Oct 2016 | The Stone Ground Peanut Butter Chocolate Bar, Net wt. 2.5 oz. UPC 8 55966 00107 9. | JJBL LLC | Food | Class II | 2 |
| 11 Oct 2016 | Chocolate Chip Cookie Dough Bar 1.6 oz, 5 count carton (75416) | Nutrisystem Inc | Food | Class I | 1 |
| 10 Oct 2016 | Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40, CD2231-40Q. Fortify ST DR, Model No. CD2241-40,… | St Jude Medical Inc. | Device | Class I | 3 |
| 10 Oct 2016 | Publix Premium Chocolate Cookie Dough Ice Cream, 1/2 gallon carton. | Publix Super Markets, Inc. | Food | Class I | 1 |
| 10 Oct 2016 | White Cheddar Cheese, 40 lb. blocks | Farm Country Cheese House, Inc. | Food | Class I | 5 |
| 10 Oct 2016 | Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude). | Wells Enterprises, Inc. | Food | Class I | 1 |
| 8 Oct 2016 | Yoma Myanmar Tea Salad Snack - Spicy, 7 oz cello bag. Product of Myanmar | Individual firm, name withheld | Food | Class I | 2 |
| 7 Oct 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 7 Oct 2016 | On Lid: Turkey Hill, Rocky Road, 48 FL. OZ.. In small letters at the top of the lid reads: "Dutch Chocolate ice cream swirled with whipped marshmallow and butter-roasted almonds" On body of Tub: Turkey Hill Rocky Road, 48 FL. OZ. On bottom of Tub: Sell By May 23, 2017 UPC: 020735420911 (75453) | Turkey Hill Dairy, LP | Food | Class I | 1 |
| 7 Oct 2016 | BELGIAN BOYS MINI PANCAKES, NET WT. 10.6 oz (300g), 36 Count, UPC 857290005204, Product of The Netherlands --- Produced exclusively for Belgian Boys, 140 Carolyn Blvd., Farmingdale, NY 11735 (75397) | Individual firm, name withheld | Food | Class I | 1 |
| 7 Oct 2016 | Organic 2oz Micro Greens. Clear Plastic Clamshell. Keep Refrigerated (75439) | Osage Gardens, Incorporated | Food | Class I | 1 |
| 7 Oct 2016 | Nestle Drumstick Club variety - 16x4.6floz US UPC# 72554-11096 Best Before Date: Between June 2 - June 15, 2017 | Nestle Dreyer's Ice Cream Company | Food | Class II | 2 |
| 7 Oct 2016 | Fit & Active 100 Calorie Whole Almonds 7 0.63oz bags per retail carton Flexible film bags in paperboard carton | Kar Nut Products Company | Food | Class II | 1 |
| 6 Oct 2016 | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. (75376) | AccessClosure, Inc., A Cardinal Health Company | Device | Class II | 1 |
| 6 Oct 2016 | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 6 Oct 2016 | NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10 | Actavis Elizabeth LLC | Drug | Class III | 1 |
| 6 Oct 2016 | Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01 | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 5 Oct 2016 | Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 5 Oct 2016 | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 5 Oct 2016 | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic… | C.R. Bard, Inc. | Device | Class II | 1 |
| 5 Oct 2016 | da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 5 Oct 2016 | Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment. | Maquet Medical Systems USA | Device | Class II | 1 |
| 5 Oct 2016 | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class I | 4 |
| 5 Oct 2016 | Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. | Individual firm, name withheld | Device | Class II | 15 |
| 5 Oct 2016 | Professional Botanicals MealPlex (756 grams) and Veo Natural Pearl 3.0 (378 grams) Ultimate Meal Drinks in Plastic Tub Containers. Dietary Supplement. (75398) | Individual firm, name withheld | Food | Class I | 1 |
| 5 Oct 2016 | Hollandaise Sauce, sold as Sallere Classic Sauces and Butters, refrigerated product. Each plastic tub has a net wt 7 oz. The label is read in parts: "***HOLLANDAISE SAUSE***Use on chicken, seafood and vegetables***. (75390) | Rikki USA, Inc. | Food | Class III | 1 |
| 4 Oct 2016 | FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (75513) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Oct 2016 | Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 4 Oct 2016 | DM Light Slices Yellow Cling Peaches -15 oz (425g) 300 x 407 | Del Monte Research Center - Walnut Creek | Food | Class II | 1 |
| 3 Oct 2016 | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile | Synthes (USA) Products LLC | Device | Class II | 8 |
| 3 Oct 2016 | TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management. (75510) | Medimaps Group | Device | Class II | 1 |
| 3 Oct 2016 | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01 | West-Ward Pharmaceuticals Corp. | Drug | Class II | 1 |
| 1 Oct 2016 | 4205 Journey Rolling Walker Product Usage: used to assist people in walking | Nova Ortho-Med Inc | Device | Class II | 1 |
| 30 Sep 2016 | PET Infusion Pump | Bayer Healthcare | Device | Class II | 1 |
| 30 Sep 2016 | Simeons Program. 2oz HCG Drops. Amber Plastic. | Infiniti Creations, LLC | Food | Class III | 19 |
| 30 Sep 2016 | Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case (75352) | Beverage International | Food | Class II | 1 |
| 29 Sep 2016 | The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients. | Sorin Group USA, Inc. | Device | Class II | 2 |
| 29 Sep 2016 | Aptio Automation Modules | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 29 Sep 2016 | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures. (75395) | SentreHeart Inc | Device | Class I | 1 |
| 29 Sep 2016 | Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles | Covidien LLC | Device | Class II | 3 |
| 28 Sep 2016 | Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 28 Sep 2016 | Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 2 |
| 27 Sep 2016 | 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a… | ICU Medical, Inc. | Device | Class II | 162 |
| 27 Sep 2016 | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 27 Sep 2016 | The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place. | Schaerer Medical USA Inc | Device | Class II | 2 |
| 27 Sep 2016 | Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically.… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 27 Sep 2016 | Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Par Pharmaceutical, Inc. | Drug | Class III | 5 |
| 25 Sep 2016 | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology. | Lumenis Limited | Device | Class II | 1 |
| 24 Sep 2016 | Label reads in part "*** Bob's Red Mill *** PREMIUM GUAR GUM SUPERB GLUTEN FREE THICKENER & BINDER *** NET WT 8 OZ ***" Product is packaged in multilayered flexible film with multiple colors. Firm brand name is printed in red. Case contains 8/8 oz. packages. UPC 0 39978 00554 0 or 0 39978 00554 1 | Bob's Red Mill Natural Foods, Inc. | Food | Class III | 1 |
| 23 Sep 2016 | Fluid Management Set. Catalog Number K08-MP5159A | Merit Medical Systems, Inc. | Device | Class II | 5 |
| 23 Sep 2016 | VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The… (75211) | Sequent Medical Inc | Device | Class II | 1 |
| 23 Sep 2016 | Frozen Onion Rings sold and distributed under the following private label retail brands: 1) Premium Pick 5 Mix and Match Onion Rings, NET WT 40 OZ, packaged in plastic bags; 2) Krasdale Onion Rings, NET WT 16 OZ, packaged in plastic bags; 3) Spartan Onion Rings, NET WT 20 OZ, packaged in plastic bags; 4) Shur Fine… | McCain Foods USA | Food | Class I | 1 |
| 23 Sep 2016 | Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plastic | Batista Bakery & Pastries, Inc. | Food | Class II | 4 |
| 23 Sep 2016 | Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02 (75360) | Mericon Industries Inc. | Food | Class II | 1 |
| 23 Sep 2016 | On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows. | Truco Enterprises, Inc | Food | Class II | 2 |
| 22 Sep 2016 | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech… | AtriCure, Inc. | Device | Class II | 1 |
| 22 Sep 2016 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. | AtriCure, Inc. | Device | Class II | 1 |
| 19 Sep 2016 | PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily… | Bausch & Lomb Inc Irb | Device | Class II | 1 |
| 19 Sep 2016 | Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 19 Sep 2016 | Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. | Encore Medical, Lp | Device | Class II | 1 |
| 19 Sep 2016 | Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network | Wells Pharmacy Network, LLC | Drug | Class II | 7 |
| 17 Sep 2016 | Club Size McCormick Original Taco Seasoning Mix 24 oz. , CASE PACK: 12/case (75391) | Mccormick | Food | Class I | 1 |
| 17 Sep 2016 | Koffee Kup Potatoe Hamburger Buns, Plain and Seeded, 8 pk | Koffee Kup Bakery Inc. | Food | Class II | 12 |
| 16 Sep 2016 | 12ct Banana Nut mini muffins labeled as 12ct Lemon poppy seed mini muffins; Date code 160803 ink jet printed on top near the label. (75294) | CV EAST LLC, CORNERSTONE MARION LLC | Food | Class I | 1 |
| 15 Sep 2016 | Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore… (73286) | Battle Creek Equipment Co. | Device | Class II | 1 |
| 15 Sep 2016 | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations… | Keystone Dental Inc | Device | Class II | 1 |
| 15 Sep 2016 | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Sep 2016 | OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub. | SM Fish Corp. | Food | Class I | 19 |
| 15 Sep 2016 | BRACH'S Chocolate Creations, Milk Chocolate Almond Supremes, Fresh roasted almonds drenched in rich creamy milk chocolate. NET WT 5 oz (142 g). Best By 04/22/2017 (75201) | Ferrara Candy Comp | Food | Class I | 1 |
| 14 Sep 2016 | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 13 Sep 2016 | ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta. | TEM Systems Inc | Device | Class II | 1 |
| 13 Sep 2016 | Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7 | Taro Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 9 Sep 2016 | SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators,… | Akita Sumitomo Bakelite Co., Ltd. | Device | Class II | 2 |
| 8 Sep 2016 | Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless… | Greatbatch Medical | Device | Class II | 1 |
| 8 Sep 2016 | TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 7 Sep 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 6 Sep 2016 | Wilton Black Airbrush Color, Net Wt 0.64 FL OZ (19 mL) | Wilton Brands. | Food | Class II | 12 |
| 2 Sep 2016 | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD" | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 2 Sep 2016 | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination. | Arrow International Inc | Device | Class II | 1 |
| 1 Sep 2016 | Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is constructed of… | Medtronic Navigation, Inc. | Device | Class II | 2 |
| 1 Sep 2016 | White Wine & Garlic Wine Drizzle, packaged in 5 oz and 8 oz glass bottles, www.winedrizzle.com, Higginsville, MO 64037 (75195) | Get Drizzled Custom Wine Drizzle, LLC | Food | Class II | 1 |
| 1 Sep 2016 | Regalo Bakery: "Spanish Rolls"[UPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6) | Regalo's Favorite of Hawaii Inc. | Food | Class I | 6 |
| 30 Aug 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 30 Aug 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30. | Actavis Laboratories, FL, Inc. | Drug | Class III | 1 |
| 29 Aug 2016 | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 29 Aug 2016 | TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057 | Smith & Nephew, Inc. | Device | Class II | 2 |
| 27 Aug 2016 | 4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine brand names. (75095) | Westby Coop Creamery | Food | Class II | 1 |
| 25 Aug 2016 | Dimension Vista IRON Flex reagent cartridges | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 2 |
| 24 Aug 2016 | Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50… | Azer Scientific, Inc. | Device | Class II | 2 |
| 24 Aug 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054 | Sandoz Inc | Drug | Class II | 1 |
| 16 Aug 2016 | Pathfast D-Dimer, Reference number: PF1051-KUS (75511) | Lsi Medience Corporation | Device | Class II | 1 |
| 15 Aug 2016 | Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid… | Pentax of America Inc | Device | Class II | 1 |
| 15 Aug 2016 | Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach… | Pentax of America Inc | Device | Class II | 1 |
| 15 Aug 2016 | Select Recipe Buttermilk Ranch Dressing, Net contents: 1 GAL (3.79 L), 4 X 1 GAL | Oasis Foods Co | Food | Class III | 2 |
| 12 Aug 2016 | Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 10 Aug 2016 | Rigid Suction Canister 3000 CC and 2000 CC. | Medline Industries Inc | Device | Class II | 1 |
| 9 Aug 2016 | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL. | Hill-Rom, Inc. | Device | Class II | 1 |
| 8 Aug 2016 | Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement. | Pharmatech LLC | Food | Class II | 23 |
| 5 Aug 2016 | Enlightened Peanut Butter Chocolate Chip Ice Cream, one pint | Cedar Crest Specialties, Inc. | Food | Class III | 1 |
| 4 Aug 2016 | Organic Cacao Nibs, packaged in 200g (7.05 oz) brown bags, UPC code 661594002032 (74881) | Level Ground Trading Limited | Food | Class III | 1 |
| 3 Aug 2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05 | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 2 Aug 2016 | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2… | Becton Dickinson & Company | Device | Class II | 1 |
| 1 Aug 2016 | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 15 Jul 2016 | Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in… | Roche Diagnostics Operations, Inc. | Device | Class II | 17 |
| 14 Jul 2016 | Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion,… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 13 Jul 2016 | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and… | Diasorin Inc. | Device | Class II | 1 |
| 13 Jul 2016 | Iberia Codfish Fritter Mix | Productos La Finca, Inc. | Food | Class II | 1 |
| 11 Jul 2016 | Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia | B. Braun Medical, Inc. | Device | Class II | 1 |
| 7 Jul 2016 | Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous… | TZ Medical, Inc. | Device | Class II | 1 |
| 4 Jul 2016 | Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or… | Zimmer Surgical Inc | Device | Class II | 1 |
| 23 Jun 2016 | PRIME TIME Cucumbers, 1 & 1/9 BUSHEL CARTON, 25kg per carton, TAG ID# 10173318, 10173319, 10173320, 10173322. (74527) | Prime Time International | Food | Class I | 1 |
| 22 Jun 2016 | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 9 Jun 2016 | FitPro Go! 14oz Strawberry; 35g protein UPC (Case): 8-5418200329-4; UPC (Individual): 8-5418200326-3 | H.P. Hood, LLC | Food | Class II | 18 |
| 4 Jun 2016 | SOFiT Protein Plus Sunflower Seeds Sea Salt; Seeds covered by a crunchy protein shell: NET WT. 1 OZ. | The Hershey Company | Food | Class I | 3 |
| 1 Jun 2016 | SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood (74786) | BBI SOLUTIONS OEM LTD | Device | Class II | 1 |
| 1 Jun 2016 | PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50. | Becton Dickinson & Co. | Device | Class III | 2 |
| 26 May 2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0%… | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 25 May 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 24 May 2016 | Protein Chews Cherry Lime,1.8oz, film package, 12 packets per box. | EN-R-G Foods, Inc. | Food | Class II | 3 |
| 6 May 2016 | Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case) (74042) | Tasty Toppings Inc | Food | Class III | 1 |
| 26 Apr 2016 | Frontera Texas Original Taco Skillet Sauce with mild red chile + cumin 8 oz. pouch | Riba Foods Inc | Food | Class II | 1 |
| 26 Apr 2016 | 7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 -- | Glenn Wayne Wholseale Bakery Inc. | Food | Class I | 3 |
| 22 Apr 2016 | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia | Epimed International, Inc. | Device | Class II | 1 |
| 21 Apr 2016 | BM Westco Mster Mix Raised Donut Mix, 50# | CSM Bakery Products NA | Food | Class II | 22 |
| 21 Apr 2016 | VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear plastic film and sold frozen in cases of 12 units, 24 units, or variety packs. The affected lots were sold in case of 24 units per case. (73970) | Individual firm, name withheld | Food | Class I | 1 |
| 21 Apr 2016 | Misty Fjord Lemon Pepper Smoked Salmon, vacuum sealed 6 oz plastic packs. | Misty Fjord Seafood LLC | Food | Class II | 3 |
| 10 Apr 2016 | Whole Foods Asparagus Pea & Ricotta Salad, 10 Ounces (73813) | Whole Foods Market North Atlantic Kitchen | Food | Class I | 1 |
| 28 Mar 2016 | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 25 Mar 2016 | Trader Joe's Chocolate Orange Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847162 | Trader Joes Company | Food | Class I | 2 |
| 18 Mar 2016 | Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 10.9 oz. (310g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil Forelka Style**Net Wt. 10.0 oz. (310g)** UPC # 825512 004915 | Royal Seafood Baza | Food | Class I | 29 |
| 15 Mar 2016 | Philips Healthcare System X-ray Tomography Computed : | Philips Electronics North America Corporation | Device | Class II | 2 |
| 26 Feb 2016 | New York Style Chocolate Iced ¿clairs under the following labels: 1) Richs New York Style Chocolate Iced ¿clairs, NET WT 8 oz (226g) (UPC Code:049800147799), 2) Bakery Fresh Goodness NY Style Chocolate ¿clairs, NET WT 8 oz (226g) (UPC Code:011110456601), 3) Food Lion NY Style Chocolate Iced ¿clairs, NET WT 8 oz… | Rich Products Corp | Food | Class II | 1 |
| 15 Feb 2016 | Porfirio's Potato Gnocchi Net Wt. 16 oz. (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319 | Porfirios Italian Foods, Inc. | Food | Class II | 9 |
| 4 Jan 2016 | Beirut Lift Turnip Pickles Imported & Distributed By: Baroody Import Inc. 1500 B Main Ave. -Clifton, NJ 07011 Tel: 973.3404832 700 g - UPC 642036014141 2 kg - UPC 642036014219 10 kg - UPC | Baroody Imports Inc. | Food | Class II | 1 |
| 13 Nov 2015 | Island Biscuit "Yum Yum - Creamy Strawberry" Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952 (72889) | Lee'S Food Corp | Food | Class III | 1 |
| 5 Mar 2015 | Merge LIS software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 24 Dec 2014 | SAUER'S BARBEQJ E SPICE, 3 oz. | C.F. Sauer Company | Food | Class I | 10 |
| 7 Nov 2014 | Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort… | Individual firm, name withheld | Device | Class II | 6 |
| 15 Apr 2014 | ReTurn 7500/7500 Aid, transfer | Handicare USA, Inc. | Device | Class II | 1 |
| 5 Feb 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 | Hospira Inc. | Device | Class II | 2 |
| 4 Feb 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral,… | Hospira Inc. | Device | Class II | 2 |
| 16 Mar 2011 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood… | Hospira Inc. | Device | Class II | 2 |