| 16 Jan 2018 | DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 12 Jan 2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16. | International Laboratories, Inc. | Drug | Class II | 2 |
| 11 Jan 2018 | SAF PRO RELAX +YF, Deactivated Dry Yeast, Product Code 73050, Net Wt. 50 LBS. (22.7 KG), manufactured for Lesaffre Yeast Company, Milwaukee, WI. Event 78923 | Name withheld | Food | Class II | 1 |
| 10 Jan 2018 | Hot Dog Buns, 6 pieces packaged in a poly bag, net wt 17.3 oz. The label is read in parts: "***HOTDOG BUNS***NET WT. 17.3 OZ***Ingredients:***Enriched unbleached wheat flour***egg, whole milk (milk, vitamin A, vitamin D3), butter***Contains: wheat, egg, dairy***". | GRAND CENTRAL BAKERY INC | Food | Class III | 2 |
| 9 Jan 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30. | Marksans Pharma Inc. | Drug | Class II | 6 |
| 5 Jan 2018 | MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10 | Advanced Pharma Inc. | Drug | Class I | 1 |
| 5 Jan 2018 | Frozen Tuna Fillet Saku (Restaurant Supply Only); 22 lbs./2 x 5 kgs. Wild caught: Handline with Hook. Keep Frozen - 18 degrees C or below Product of Indonesia; Packed for H.I.G. Corporation. Carson, CA Event 78898 | H.I.G. Corporation | Food | Class I | 1 |
| 3 Jan 2018 | Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15. | AVKARE Inc. | Drug | Class II | 1 |
| 3 Jan 2018 | Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes) Event 78890 | Paris Foods Corporation | Food | Class III | 1 |
| 3 Jan 2018 | Orange Cream Ice Cream Bars sold under the following labels: Sold in a 12-pack: Ahold UPC: 6 88267 03292 9, Econo UPC: 7 08938 00610 0, First Street no OCB s, Food Club UPC: 7 08938 00610 0, Giant Eagle UPC: 0 30034 00337 1, Great Value no OCB s, Greens UPC: 0 71441 03130 4, Hagan UPC: 0 37498 01609 1, Hood UPC: 0… | Fieldbrook Foods Corporation | Food | Class I | 4 |
| 2 Jan 2018 | Wahon Slice Shitake Mushroom 2.5 oz. (71g) UPC : #737483336851 Event 78846 | Vinh Sanh Trading Corp | Food | Class III | 1 |
| 2 Jan 2018 | Coconut Tree Brand Shredded Coconut; frozen Dua Bao; Net WT. 16 oz. (454 g); Product of Vietnam; UPC 05216-44081 Ingredient: Coconut Manufactured by: Lucky Shing Co., LTD 108/1 Road No. 830, Hamlet No. 3 An Thanh Village, Ben Luc District Long An Province, Vietnam. | Evershing International Trading Inc. | Food | Class I | 1 |
| 2 Jan 2018 | Condies Foods Fresh Fruit, Item Number 40781, UPC 50777222655 | Condies Foods, Inc. | Food | Class I | 1 |
| 31 Dec 2017 | Blommer Chocolate Company ERNIES (chocolate candy centers with candy shell) Net Wt. 25 lbs. Ingredients: Sugar, cocoa, hydrogenated palm kernel oil, whey, artificial color (FD&C Blue No. 1, Blue No 1 Lake, Blue #2 Lake, Yellow #5, Yellow No. 5 Lake, Yellow No. 6, Yellow No. 6 Lake, Red No 40, Red No 40 Lake,… Event 78912 | Blommer Chocolate Company of California, LLC | Food | Class II | 1 |
| 29 Dec 2017 | Hanryosued (F. Dashi Anchovy) 1.5kg x pack/carton UPC 826546102745, 826546102378 Event 78844 | Hong Chang Corporation | Food | Class I | 1 |
| 29 Dec 2017 | The Coconut Cult Coconut Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765282, 611138765275, 611138765268 | Lovebiotics, LLC | Food | Class II | 2 |
| 28 Dec 2017 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307. Event 78841 | DLC Laboratories, Inc | Drug | Class II | 1 |
| 28 Dec 2017 | New Seasons Market Grab and Go Pre-Packaged Macaroni and Cheese - refrigerated. Product is packaged in aluminum shallow containers with a clear plastic dome lid and sold in two sizes: Small package UPC 252089 203999. Large package UPC 252090 706991. The label is read in parts: "***NEW SEASONS MARKET MACARONI &… | NEW SEASONS MARKET | Food | Class I | 1 |
| 27 Dec 2017 | Old Fashioned Pecan Divinity; Net Wt. 8 OZ. (226g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 8 oz. clear plastic tubs with removable clear plastic lids. | Crown Candy Corporation | Food | Class II | 2 |
| 22 Dec 2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10 Event 78821 | Name withheld | Drug | Class III | 1 |
| 22 Dec 2017 | Daisy s Bakery Inc., Gourmet Concha, 4 oz. / 1 per package, Plastic Bag, 12 units per case Event 78831 | Daisy's Bakery Inc. | Food | Class I | 1 |
| 22 Dec 2017 | CO YO Coconut Yogurt Alternative CHOCOLATE, 5.3 oz and 12 oz. plastic container, 6 packages per case. Store between 36 and 42 F. Manufactured by COCONUTHEAD, LLC, Albuquerque NM; Distributed by UNFI and KeHE Event 78823 | Coconuthead, LLC | Food | Class II | 1 |
| 22 Dec 2017 | Smoked salmon in 1.5 oz. and 8 oz. packages Event 78818 | Nodine's Smokehouse Inc. | Food | Class I | 1 |
| 22 Dec 2017 | Harris Teeter's HT Traders Mama Biscotti Mini Biscotti, Triple Chocolate, UPC: 7203670827. Event 78819 | Harris Teeter Distribution Ctr | Food | Class II | 1 |
| 22 Dec 2017 | Early Dawn; Whole Tilapia IQF, Gutted & Scaled, Farm Raised, 40 lbs.; Size 550-750g OR 750g+, Lot No.: 1985507; Production Date: 08/12/2017; Best Used By Date: 02/12/2019; Product of China. Event 78829 | AJC International, Inc. | Food | Class II | 1 |
| 22 Dec 2017 | Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9 Event 78801 | Bellisio Foods Inc | Food | Class I | 1 |
| 21 Dec 2017 | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 21 Dec 2017 | Red Button Vintage Creamery, Caramel Cashew Ice Cream, 56 fluid ounce. UPC 077865010109. Case Pack UPC # 077865010109 AFS Item Number 6470413. Packaged in Paper Tubs. | Casper's Ice Cream, Inc | Food | Class II | 1 |
| 21 Dec 2017 | Polly Ann Green Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26666 9 | California Popsicle, Inc. | Food | Class I | 3 |
| 21 Dec 2017 | Light String Cheese, Part Skim Mozzarella cheese, sold under the following brands and package sizes: 1. Fit & Active, 10 oz,., 12 individually wrapped pieces. UPC 041498-190293; 2. LIDL, 10 oz., 12 individually wrapped pieces. BEST BY 29MAR18L3 3. Market Pantry, 5 oz,., 6 individually wrapped pieces. UPC… | Saputo Cheese USA Inc. | Food | Class II | 1 |
| 21 Dec 2017 | SHS Wel-Plan Wheat and Corn Strach Baking Mix , 400 g box,Cardboard carton, 18 cartons per case, but distributed by individual unit (carton). | Nutricia North America | Food | Class II | 1 |
| 20 Dec 2017 | Day Cream SPF15 Crème de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0 | Odan Laboratories Ltd | Drug | Class II | 2 |
| 20 Dec 2017 | Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998. | NEW SEASONS MARKET | Food | Class II | 1 |
| 19 Dec 2017 | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02… | DeRoyal Industries Inc | Device | Class II | 1 |
| 19 Dec 2017 | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01 | Unichem Pharmaceuticals Usa Inc | Drug | Class II | 1 |
| 19 Dec 2017 | Haldiram's Fresh Paneer Traditional Indian Soft Cottage Cheese, Net Weight 800g (28.2 oz) Event 78814 | KOTECHA BROTHERS, LLC. | Food | Class I | 1 |
| 19 Dec 2017 | 3lb Bag Dice Red Apples - no brand. 4 units per case | Fresh Pak, Inc. | Food | Class I | 6 |
| 19 Dec 2017 | Jalebi, .5-1 lb. Clear Plastic clamshell containers | New Punjab Sweets Inc. | Food | Class II | 9 |
| 18 Dec 2017 | Meijer Michigan Harvest Salad 10 Oz retail unit in plastic container UPC: 7-08820-68400-3 4 retail containers per wholesale case | Meijer Distribution, Inc | Food | Class I | 3 |
| 18 Dec 2017 | REEF NET brand Wild Pacific Smoked Salmon. Product is Ready-To-Eat, hot smoked, vacuum packaged in 1 lb.; 1.5 lbs.; and 2 lbs. package, keep refrigerated or keep frozen. The label is read in parts: "***REEF NET Brand *** Wild Pacific Smoked Salmon***Ingredients: Fish, salt, brown sugar, natural wood… Event 78779 | Barlean's Fishery Inc. | Food | Class III | 1 |
| 18 Dec 2017 | Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count | Gel Spice Co, Inc. | Food | Class I | 2 |
| 18 Dec 2017 | Frozen Southern Style Biscuits; 25 oz. bags (12 count) | Ingles Markets | Food | Class II | 2 |
| 17 Dec 2017 | Gala, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case | Jack Brown Produce, Inc. | Food | Class I | 4 |
| 15 Dec 2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47 | Akorn Inc | Drug | Class III | 1 |
| 14 Dec 2017 | Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 14 Dec 2017 | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01 | SHISEIDO AMERICA INC. | Drug | Class II | 5 |
| 14 Dec 2017 | Sugar Syrup / Bulk / Tanker Truck #1 & 2 Event 78778 | American Sugar Refining, Inc. | Food | Class II | 1 |
| 14 Dec 2017 | Golden delicious whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct, individual apples on trays with re-useable plastic… | Nyblad Orchards | Food | Class I | 4 |
| 13 Dec 2017 | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 13 Dec 2017 | 365 brand Egg Nog, Grade A; 1 qt. and 1/2 GAL; and Harrisburg Dairies brand Egg Nog, Grade A; 1/2 GAL, 1 Quart, 16 FL. OZ. Event 78834 | Harrisburg Dairies, Inc | Food | Class II | 1 |
| 12 Dec 2017 | DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery. | Encore Medical, Lp | Device | Class II | 4 |
| 12 Dec 2017 | Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16 Event 78757 | Woodfield Pharmaceutical, LLC | Drug | Class II | 1 |
| 12 Dec 2017 | Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01 Event 78773 | Keryx Biopharmaceuticals, Inc. | Drug | Class III | 1 |
| 12 Dec 2017 | Smoked Salmon packed under Springfield Smoked Fish and Rachael's: - Rachael s SPRINGFIELD SMOKED FISH HAND CUT STYLE SMOKED NOVA SALMON, 4 oz. UPC: 045049113342; - Rachael s SPRINGFIELD SMOKED FISH SMOKED SLICED NOVA SALMON, 4 oz., UPC: 045049113250; Rachael s SPRINGFIELD SMOKED FISH SMOKED SLICED NOVA SALMON 8 oz.,… | Rachael's Food Corporation | Food | Class I | 19 |
| 12 Dec 2017 | Paprika Sweet American Garden 12/3.25oz, Global Food Export | Spice Chain Corporation | Food | Class II | 9 |
| 11 Dec 2017 | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are… | Smith & Nephew, Inc. | Device | Class II | 2 |
| 11 Dec 2017 | Rosemary Poppyseed crackers, net wt. 6 oz., packaged in clear poly bag with a twist tie. No UPC code. The label is read in parts: "***Ingredients: Flour, Baking Powder, Salt, Extra Virgin Olive Oil, Fresh Rosemary, Poppyseeds. This bag may contain one or more of the following allergens: Soy, Wheat Flour, Eggs,… Event 78737 | Lovejoy Bakers Inc | Food | Class II | 1 |
| 8 Dec 2017 | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. | Remel Inc | Device | Class II | 1 |
| 7 Dec 2017 | ACCOLADE SR Pacemaker | Boston Scientific Corporation | Device | Class II | 24 |
| 7 Dec 2017 | BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481 Event 78720 | BotanicalNow | Drug | Class I | 1 |
| 7 Dec 2017 | Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12 | SCA Pharmaceuticals | Drug | Class II | 1 |
| 7 Dec 2017 | Rapunzel Vegetable Bouillon ( no added salt ), 2.4 oz. net weight, in a thick paper sleeve containing 8 foil-wrapped bouillon cubes, 12 units per case . | World Finer Foods, Inc. | Food | Class II | 1 |
| 7 Dec 2017 | Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ventura Foods, LLC, Lot codes: 33317; Culinary Secrets Country French Dressing; Net Wt. 1.5 OZ.; Lot Codes: 04 29 18; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Gordon Choice California-Style Red French Dressing; Net Contents… | Ventura Foods, LLC | Food | Class II | 12 |
| 6 Dec 2017 | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 5 Dec 2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10 | Sanofi-Aventis U.S. LLC | Drug | Class III | 1 |
| 4 Dec 2017 | LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response… | Physio-Control, Inc. | Device | Class I | 1 |
| 4 Dec 2017 | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50 Event 78697 | Solco Healtcare US LLC | Drug | Class II | 1 |
| 4 Dec 2017 | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10 | ALLERGAN | Drug | Class II | 1 |
| 4 Dec 2017 | Publix brand, item # 41596, Southern Style Diced Hash Brown Potatoes, Net wt. 32 oz. Retail's UPC # 0 41415 00549 5. The label is read in parts: "***Publix Southern Style DICED HASH BROWN POTATOES***DISTRIBUTED BY PUBLIX SUPERMARKETS, INC. LAKELAND, FL 33802***". | McCain Foods USA | Food | Class III | 1 |
| 2 Dec 2017 | Sundream 12 V tanning bed Event 78571 | ProSun International, LLC | Device | Class II | 1 |
| 29 Nov 2017 | smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 29 Nov 2017 | Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09. | Prinston Pharmaceutical Inc | Drug | Class II | 1 |
| 28 Nov 2017 | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter Event 78716 | Name withheld | Device | Class II | 1 |
| 27 Nov 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the… | SPINEART SA | Device | Class II | 7 |
| 22 Nov 2017 | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 19 Nov 2017 | Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA Event 78643 | Name withheld | Drug | Class I | 1 |
| 19 Nov 2017 | Dark Chocolate Pecans Net Wt. 7 oz, Farrell Farms, 200 Gin Road, Goldsboro, NC | Farrell Farms, Inc | Food | Class I | 3 |
| 17 Nov 2017 | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are… | CareFusion 303, Inc. | Device | Class II | 2 |
| 17 Nov 2017 | Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the… | Accuray Incorporated | Device | Class II | 4 |
| 16 Nov 2017 | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left | Brainlab AG | Device | Class II | 1 |
| 16 Nov 2017 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | KRS Global Biotechnology, Inc | Drug | Class II | 47 |
| 15 Nov 2017 | Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree. | Cordis Corporation | Device | Class II | 1 |
| 11 Nov 2017 | BUSH'S BEST Homestyle TANGY SAUCE WITH BACON & BROWN SUGAR BAKED BEANS 55 OZ (3 LB 7 OZ) 1.56 kg BUSH BROTHERS & COMPANY P.O. Box 52330, Dep. C KNOXVILLE, TN 37950-2330 | Bush Brothers & Co | Food | Class II | 2 |
| 10 Nov 2017 | Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 4 |
| 10 Nov 2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577 | Bayer HealthCare Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 9 Nov 2017 | Dark Chocolate covered Gingersnaps. Packaged as follows: 1. in clear plastic ziplock bag, sizes range from 8 oz - 12 oz., product code 038-6025-901 2. in a decorative circular gift tin, product #0368 Christmas Ginger Snap Variety | Figi's, Inc | Food | Class II | 1 |
| 8 Nov 2017 | Philips Healthcare Brilliance iCT computed tomography x-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 8 Nov 2017 | Nestle HOT POCKETS FOUR CHEESE PIZZA SNACK BITES in clear plastic bags. | Nestle USA | Food | Class II | 1 |
| 6 Nov 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. | Owen Mumford USA, Inc. | Device | Class II | 2 |
| 6 Nov 2017 | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class III | 3 |
| 3 Nov 2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 30 Oct 2017 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor. | Sorin Group Deutschland GmbH | Device | Class II | 1 |
| 30 Oct 2017 | ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland,… | Pharmedium Services, LLC | Drug | Class II | 1 |
| 27 Oct 2017 | L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage. Event 78658 | L3 Security & Detection | Device | Class II | 1 |
| 27 Oct 2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20 | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 23 Oct 2017 | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 20 Oct 2017 | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977 | Pfizer Inc. | Drug | Class I | 2 |
| 19 Oct 2017 | CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography | Philips Electronics North America Corporation | Device | Class II | 1 |
| 9 Oct 2017 | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S | Inovo, Inc | Device | Class II | 1 |
| 29 Sep 2017 | OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 27 Sep 2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING Event 78682 | Pfizer Manufacturing Deutschland GmbH | Drug | Class II | 1 |
| 26 Sep 2017 | Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20 | Pharmedium Services, LLC | Drug | Class II | 1 |
| 26 Sep 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28 | Pharmedium Services, LLC | Drug | Class III | 3 |
| 20 Sep 2017 | Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885 Event 78073 | Name withheld | Drug | Class I | 1 |
| 19 Sep 2017 | daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 12 Sep 2017 | LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Event 78926 | Zoll Manufacturing Corp. | Device | Class II | 1 |
| 5 Sep 2017 | Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05 Event 78657 | Simple Diagnostics, Inc. | Drug | Class II | 1 |
| 5 Sep 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Drug | Class II | 4 |
| 31 Aug 2017 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. | Orthoscan, Inc. | Device | Class II | 4 |
| 23 Aug 2017 | IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 22 Aug 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics,… | Smiths Medical ASD Inc. | Device | Class II | 2 |
| 16 Aug 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL | Pharmatech LLC | Drug | Class II | 4 |
| 16 Aug 2017 | Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97 | Pharmatech LLC | Food | Class II | 17 |
| 10 Aug 2017 | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81 | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Drug | Class II | 10 |
| 25 Jul 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 21 Jul 2017 | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to… | Edwards Lifesciences, LLC | Device | Class I | 1 |
| 18 Jul 2017 | Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case. | Medline Industries Inc | Device | Class II | 1 |
| 18 Jul 2017 | BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females. | Becton Dickinson & Co. | Device | Class II | 3 |
| 17 Jul 2017 | RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 17 Jul 2017 | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014 | Philips Electronics North America Corporation | Device | Class II | 1 |
| 14 Jul 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or… | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 2 |
| 14 Jul 2017 | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 14 Jul 2017 | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other… | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 2 |
| 11 Jul 2017 | Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 7 Jul 2017 | Mac Pin Non-Cannulated Screw, 6.5 x 60mm | Amendia, Inc | Device | Class II | 1 |
| 7 Jul 2017 | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System. | Amendia, Inc | Device | Class II | 1 |
| 7 Jul 2017 | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 | Hologic, Inc. | Device | Class II | 1 |
| 5 Jul 2017 | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO… | Orthofix Srl | Device | Class II | 1 |
| 5 Jul 2017 | SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS. | Centurion Medical Products Corporation | Device | Class II | 1 |
| 5 Jul 2017 | Persona Partial Knee System, Size 8, Finishing Guide | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 5 Jul 2017 | Phadia 1000 Instrument, Article Number 12-3800-01. | Phadia US Inc | Device | Class II | 1 |
| 29 Jun 2017 | PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 29 Jun 2017 | Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 03022109001 03023109973 03739040001 03739040692 05023572001 05023599001 cobas e 601 module … | Roche Diagnostics Corporation | Device | Class II | 1 |
| 20 Jun 2017 | Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates. | Hamilton Medical, Inc. | Device | Class II | 1 |
| 15 Jun 2017 | PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. Event 78802 | TEI Biosciences | Device | Class II | 1 |
| 12 Jun 2017 | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 7 Jun 2017 | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3:… | Randox Laboratories Ltd. | Device | Class II | 1 |
| 5 Jun 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Zimmer Biomet, Inc. | Device | Class II | 10 |
| 2 Jun 2017 | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various… | Sterilmed Inc | Device | Class I | 1 |
| 24 May 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30 | Shionogi Inc. | Drug | Class III | 1 |
| 22 May 2017 | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE Event 78349 | Somatex Medical Technologies GmbH | Device | Class II | 1 |
| 6 Apr 2017 | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 15 Mar 2017 | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z,… | King Systems Corp. dba Ambu, Inc. | Device | Class II | 1 |
| 13 Mar 2017 | Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring… Event 78036 | Measurement Specialties Inc | Device | Class II | 1 |
| 13 Mar 2017 | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. --- CDRH… | Valeant Pharmacueticals International | Device | Class II | 1 |
| 14 Feb 2017 | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process. | Euro Diagnostica AB | Device | Class II | 1 |
| 9 Jan 2017 | Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11 Event 78842 | Name withheld | Drug | Class II | 1 |
| 10 Mar 2016 | Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180. | Repro-Med Systems, Inc. | Device | Class II | 2 |
| 29 Nov 2014 | Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and… | Vyaire Medical | Device | Class I | 4 |