| 14 Sep 2017 | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07;… | Medisca, Inc. | Drug | Class II | 1 |
| 13 Sep 2017 | Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044 | Amgen, Inc. | Drug | Class II | 1 |
| 8 Sep 2017 | Maradol Papaya; Frutas Selectas De Tijuana, S. DE R.L. DE, C.V. Sold in 14.00 kg/ 31 Lb. cardboard boxes. (78103) | Bravo Produce Inc | Food | Class I | 1 |
| 8 Sep 2017 | San Francisco Foods Seafood Salad; Deli Style Seafood Salad with Greek Yogurt; 4 x 4 oz. (113 g) cups Net Wt. 16 oz. (1 LB) 454 g; Carton UPC bar code of 47502 19701 Single Serve Cup: UPC 47502 19001 Perishable, Keep Refrigerated. Simply Fresh Foods, Inc. Buena Park, CA 90620 (78094) | SIMPLY FRESH FOODS INC | Food | Class I | 1 |
| 5 Sep 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30 | Aidarex Pharmaceuticals LLC | Drug | Class III | 1 |
| 5 Sep 2017 | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27 | Genentech, Inc. | Drug | Class I | 1 |
| 5 Sep 2017 | Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a foil bag | NOW Foods | Food | Class II | 1 |
| 5 Sep 2017 | Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g packaged in clear plastic shell. UPC: 77890-22744 . | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 1 Sep 2017 | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | Baxter Healthcare Corp | Device | Class II | 1 |
| 30 Aug 2017 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3 | Noven Pharmaceuticals, Inc. | Drug | Class II | 4 |
| 30 Aug 2017 | Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1. | Mid Valley Pharmaceutical | Drug | Class II | 2 |
| 28 Aug 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10 | Mckesson Packaging Services | Drug | Class III | 1 |
| 28 Aug 2017 | Breaded Fish with Vera Cruz Sauce; In 13.4 oz 3 compartment tray that has the fish, rice pilaf and green peas. Item number KD-0003 No labeling on individual trays, only on out box of 4 meals per case. (78039) | Bateman Community Living | Food | Class II | 1 |
| 28 Aug 2017 | 12" homestyle pizza crusts packed 18 to a case (no consumer packaging) labeled as: Tomanetti Pizza Crusts with the 18-12" Homestyle 9111 block checked.; Keep Frozen; Pizza Crusts; Tomanetti Food Products, 625 Allegheny Avenue, Oakmont, PA 15139 stamped with code: Manufactured date 7-17-2017 (78072) | Tomanetti Food Products Inc | Food | Class II | 1 |
| 25 Aug 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to… | Biomerieux Inc | Device | Class II | 1 |
| 24 Aug 2017 | Handsome Brook Farm Soy-Free Organic Pasture-Raised Eggs, UPC 8-66332-00011-4. The product is packaged in a tan, paper pulp egg carton with a bright pink label. (78001) | Handsome Brook Farm, LLC | Food | Class II | 1 |
| 24 Aug 2017 | Big Win Butter Popcorn, 5 oz., Butter Popcorn Artificially Flavored; Uncle Ray's 10 oz., Gourmet Select 12 oz., Gold Emblem 5 oz., and Spartan 8 oz. (78006) | Dedinas Franzak Enterprises dba Cheeze Kurls Inc.c. | Food | Class II | 1 |
| 24 Aug 2017 | Laxmi Rusks, 10.58 OZ (300 gram) bags; UPC Code: 7 23246 26482 0 | House of Spices India, Inc. | Food | Class II | 1 |
| 22 Aug 2017 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial) | Pfizer Inc. | Drug | Class II | 2 |
| 22 Aug 2017 | Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16 | Centurion Labs, LLC | Drug | Class II | 2 |
| 22 Aug 2017 | Joy's Gourmet Olive Tapenade with Blue Cheese, All Natural, Net Wt. 10 OZ. (280g) | Joy's International Foods | Food | Class II | 7 |
| 21 Aug 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. | Beckman Coulter Inc. | Device | Class II | 1 |
| 21 Aug 2017 | Organic Great Value Dark Sweet Cherry Products Pitted, Net Wt 32 Oz (2 lb) 907 g, Distributed by Wal-Mart Stores, Inc. Bentonville, AR (77985) | SUNOPTA GRAINS AND FOODS | Food | Class I | 1 |
| 18 Aug 2017 | Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 17 Aug 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 | VistaPharm, Inc. | Drug | Class III | 1 |
| 17 Aug 2017 | Java Monster Loco Moca Coffee & Energy, Net Wt. 15 fl. oz. (443 mL); UPC 0 70847 81271 5; INGREDIENTS: BREWED COFFEE (FILTERED WATER., COFFEE, CONDENSED SKIM MILK. SUGAR, HEAVY CREAM. GLUCOSE. NATURAL FLAVORS. TAURlNE,. SODIUM CITRATE, MICiOCRYSTALLINE CELLULOSE. PANAX GINSENG EXTRACT, ASCORBIC ACID (VIT. C),… (77999) | Monster Energy Company | Food | Class II | 1 |
| 16 Aug 2017 | Honest Kids Juice Slushy Blueberry Punch, 3.5-oz. pouch, UPC 0065762211116. | The Coca-Cola Company | Food | Class II | 1 |
| 15 Aug 2017 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00 (77988) | Amphastar Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 15 Aug 2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA. | Bella Pharmaceuticals, Inc. | Drug | Class II | 16 |
| 14 Aug 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 14 Aug 2017 | (a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz. pouch, UPC: 8-56088-00315-6 (b) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 2oz. cup UPC: 8-56088-00311-8 (77947) | Garden Of Light Inc. | Food | Class II | 1 |
| 14 Aug 2017 | Scampi Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens | Dierbergs Markets, Inc Corporate Office | Food | Class I | 2 |
| 13 Aug 2017 | Dark Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77469 1. The label is read in parts: ***Dark Chocolate***Jete Nutritional Energy Bar***Contains Nuts***INGREDIENTS: Peanut Butter, Apple/Plum, Dark Chocolate, Oats, Brown… | Kelejete LLC | Food | Class I | 3 |
| 11 Aug 2017 | Gazab Green Raisins, 7 oz. 14 oz. packages, 20/25 packs/carton (77940) | United Trading Inc. | Food | Class I | 1 |
| 11 Aug 2017 | 4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1.76 oz (50g) Outer Box: UPC: 60265220102-8 | KIND, LLC | Food | Class II | 1 |
| 11 Aug 2017 | Madhava Naturally Sweet Deliciously Organic MMM... Chocolate Chip Cookie Mix,, 13.8 oz. , UPC 0 78314 25105 0. Packaged in box, 6 packages per case, Ambient storage. (77943) | Madhava Honey Ltd | Food | Class I | 1 |
| 11 Aug 2017 | OPA by Litehouse Ranch, 6/11.25 oz. glass round bottles per case. The retail label listed item #48246 and has the UPC 0 77661 15022 1. The UPC on master case outer label is 01 1 0077661 13948 3. The recalled product's retail label is read in parts: "***OPA BY LITEHOUSE*** ranch *** GREEK YOGURT DRESSING***11.25 FL… | Litehouse Inc | Food | Class I | 1 |
| 11 Aug 2017 | Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary. | Rushing Waters Fisheries, LLC | Food | Class III | 3 |
| 10 Aug 2017 | CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are… | Med Tec Inc | Device | Class II | 2 |
| 10 Aug 2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00. | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 8 Aug 2017 | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators | Leonhard Lang Medizintechnik GmbH | Device | Class I | 1 |
| 7 Aug 2017 | MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. | Microvention, Inc. | Device | Class II | 1 |
| 7 Aug 2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Mako Surgical Corporation | Device | Class II | 2 |
| 7 Aug 2017 | German chocolate cakes labeled as Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow, Net Wt. 1 lb 1 oz (482 g), UPC 0 41218 31168 6 | Schnucks Markets Corporate Office | Food | Class II | 1 |
| 7 Aug 2017 | Valery Brand Maradol Papayas sold fresh in 35 pound boxes. Labeled grown and packed by Carica de Campeche (77897) | Fresh Tex Produce, LLC | Food | Class I | 1 |
| 7 Aug 2017 | Michele s Toasted Muesli, 16 oz bags, 12 units per case (77914) | Michele's Granola LLC | Food | Class I | 1 |
| 7 Aug 2017 | CARLA'S PASTA, INC. BASIL PESTO SAUCE: BULK, Mfd. Date 06/20/17, KEEP FROZEN NET WT. 13.40 LBS (6.08 kg) 00021605014209 (77918) | Carla's Pasta, Inc. | Food | Class I | 1 |
| 7 Aug 2017 | Mary's Gone Crackers Original Crackers: Organic, Gluten Free, Non-GMO, Vegan. 6.5 oz. (184 g) box; Ingredients: Whole grain brown rice, whole grain quinoa, brown flax seeds, brown sesame seeds, filtered water, sea salt, wheat free tamari (water, whole soybeans, salt, vinegar). Contains: Soy. Unit UPC: 8 97580 00010… (77909) | Mary's Gone Crackers, Inc. | Food | Class III | 1 |
| 4 Aug 2017 | MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58 | Encore Medical, Lp | Device | Class II | 1 |
| 4 Aug 2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09 (78034) | Degasa Sa De Cv | Drug | Class II | 1 |
| 4 Aug 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma,… | Pfizer Inc. | Drug | Class III | 2 |
| 4 Aug 2017 | El Chilar Whole Ginger, NET WT 1.25 Oz (35g) (77931) | Individual firm, name withheld | Food | Class II | 1 |
| 4 Aug 2017 | Kilby Cream Ice Cream, Almond Delight Size: 7 oz. and Gallon | Individual firm, name withheld | Food | Class II | 35 |
| 3 Aug 2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16 | MEDLINE INDUSTRIES INC | Drug | Class II | 1 |
| 3 Aug 2017 | Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRIBUTED BY: AGROSONS LLC (77873) | AGROSONS LLC | Food | Class I | 1 |
| 2 Aug 2017 | Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of… | Orthofix, Inc | Device | Class II | 1 |
| 2 Aug 2017 | Rugby Calcionate Syrup, One Pint (473 mL) | The Harvard Drug Group | Food | Class II | 17 |
| 2 Aug 2017 | Amrita Chocolate Maca 15g Protein Bar, 60 gm UPC: 853009004056 | Amrita Health Foods | Food | Class I | 9 |
| 1 Aug 2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures | Cardinal Health 200, LLC | Device | Class II | 1 |
| 27 Jul 2017 | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including… | Optovue, Inc. | Device | Class II | 3 |
| 27 Jul 2017 | Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags. (77912) | Newark Nut Stores, Inc. | Food | Class II | 1 |
| 25 Jul 2017 | CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO. (77844) | Gold Medal Products Co | Food | Class II | 1 |
| 24 Jul 2017 | X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector. (77843) | X-Laser Llc | Device | Class II | 1 |
| 24 Jul 2017 | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 21 Jul 2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY (77812) | Chiavna Saffron LLC | Drug | Class I | 1 |
| 21 Jul 2017 | Caribena yellow maradol papaya packed in 35 pound cases (77815) | GRANDE PRODUCE LTD CO | Food | Class I | 1 |
| 20 Jul 2017 | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing. | Beckman Coulter Inc. | Device | Class II | 1 |
| 19 Jul 2017 | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and… (77916) | Kamiya Biomedical Company, LLC | Device | Class II | 1 |
| 18 Jul 2017 | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle),… | Vyaire Medical | Device | Class II | 1 |
| 17 Jul 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through… | Maquet Datascope Corp - Cardiac Assist Division | Device | Class I | 3 |
| 17 Jul 2017 | New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com (77768) | BESTHERBS COFFEE LLC | Drug | Class I | 1 |
| 14 Jul 2017 | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed,… | Leica Biosystems Richmond Inc. | Device | Class II | 7 |
| 13 Jul 2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. | Medtronic Vascular Galway DBA Medtronic Ireland | Device | Class II | 2 |
| 12 Jul 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. | Biomerieux Inc | Device | Class II | 2 |
| 7 Jul 2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit | Qualigen Inc | Device | Class II | 1 |
| 6 Jul 2017 | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 4 Jul 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur. | Stanmore Implants Worldwide Ltd. | Device | Class II | 1 |
| 30 Jun 2017 | MOSAIQ Medical Charged-Particle Radiation Therapy System | Elekta, Inc. | Device | Class II | 1 |
| 29 Jun 2017 | Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be… | Medtronic Navigation, Inc. | Device | Class II | 5 |
| 26 Jun 2017 | Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection | Certified Safety Mfg Inc | Device | Class II | 1 |
| 26 Jun 2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect… | Ameditech Inc | Device | Class III | 1 |
| 26 Jun 2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 26 Jun 2017 | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells… | Beckman Coulter Inc. | Device | Class II | 2 |
| 23 Jun 2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX. | Kentec Medical Inc | Device | Class II | 2 |
| 23 Jun 2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA | ImprimisRx CA, Inc., dba ImprimisRx | Drug | Class II | 4 |
| 20 Jun 2017 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for… | Beckman Coulter Inc. | Device | Class II | 1 |
| 15 Jun 2017 | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01 | Tris Pharma Inc. | Drug | Class II | 1 |
| 14 Jun 2017 | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC… (77706) | Medspira, Llc | Device | Class II | 1 |
| 13 Jun 2017 | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick… | Becton Dickinson & Company | Device | Class II | 1 |
| 13 Jun 2017 | HEALTH WARRIOR CHIA BAR ACAI BERRY NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews) | Belmont Confections Inc | Food | Class I | 7 |
| 6 Jun 2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8 | Andropharm, LLC | Drug | Class I | 2 |
| 5 Jun 2017 | CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 1 Jun 2017 | MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns. (77633) | Master & Frank (Pinghu) Co., Ltd. | Device | Class II | 1 |
| 25 May 2017 | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are… | Alcon Research, Ltd. | Device | Class II | 1 |
| 24 May 2017 | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications | NeuroLogica Corporation | Device | Class II | 1 |
| 19 May 2017 | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed… | Neusoft Medical Systems Co., Ltd. | Device | Class II | 2 |
| 15 May 2017 | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a… | Boston Scientific Corporation | Device | Class II | 1 |
| 5 May 2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10 | Ascend Laboratories LLC | Drug | Class III | 1 |
| 2 May 2017 | Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 10 Apr 2017 | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment). | bioMerieux, Inc. | Device | Class II | 1 |
| 6 Apr 2017 | Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52. | PharMedium Services, Llc | Drug | Class II | 2 |
| 23 Mar 2017 | Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine,… (77888) | Toshiba American Medical Systems | Device | Class II | 1 |
| 20 Mar 2017 | Zlotoklos brand Ciastka maslane w czekoladzie (Butter cookies in chocolate), 12.3 oz (350 g). Product is packaged in a plastic tray with foil overwrap, 12 packages per case. (76909) | Individual firm, name withheld | Food | Class II | 1 |
| 15 Mar 2017 | Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 20 Dec 2016 | Southeastern Mills, Biscuit Gravy Mix, Net Wt. 2.75oz (77g), 4.5oz (128g) flexible plastic packages. | Southeastern Mills Custom Seasoning Solutions | Food | Class I | 6 |
| 18 Feb 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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… | Siemens Medical Solutions USA, Inc | Device | Class II | 12 |
| 20 Jan 2016 | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 9 Mar 2015 | Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 2 |
| 12 Feb 2014 | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. | CryoLife, Inc. | Device | Class II | 1 |