| 17 Nov 2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09 | Lupin Limited | Drug | Class II | 1 |
| 15 Nov 2017 | Brewhouse Macadamia Nut Cookie Dough Net Case Wt.: 26 LB 4 oz.. Frozen Net Unit Wt. 3 oz. Approximate Count:140 Product Code: 13804 UPC: 0 00 49800 13804 9 | Rich Products Corp | Food | Class II | 1 |
| 13 Nov 2017 | Arise Gluten Free Bakery Wild Yeast Sourdough; NET WEIGHT 24 OZ (680 grams) UPC 095225600005 | Arise Gluten Free Bakery | Food | Class II | 2 |
| 9 Nov 2017 | Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate., Costco item # 2335. The product is packaged in a clear plastic bag, net weight 5-pounds and has the UPC 37041 05211. The product label is read in parts: "***Dilettante Chocolates, Kent WA 98032, Dilettante Chocolates 19016… (78547) | Seattle Gourmet Foods Inc. | Food | Class I | 1 |
| 9 Nov 2017 | SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Outer case: Net Wt 36 lb (16.32 kg). UPC 1 00 26700 13499 6. Ventura Foods, Brea, CA 92821 | Ventura Foods Llc | Food | Class II | 1 |
| 7 Nov 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution… | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 7 Nov 2017 | Caprese Panini, Net WT: 7 oz/198g, UPC 7 62089 10728 4, Etai's, individual plastic container, keep under refrigeration | Etai's Food, Inc | Food | Class I | 2 |
| 6 Nov 2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. | West-Ward Pharmaceuticals Corp. | Drug | Class III | 2 |
| 3 Nov 2017 | Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com | Ridge Properties, LLC | Drug | Class II | 5 |
| 1 Nov 2017 | Slim & Sassy¿ TrimShake Chocolate, SKU 35200001, 1 lb 5.9 oz, HDPE tub | doTERRA International, LLC | Food | Class I | 2 |
| 1 Nov 2017 | Nature's Touch US frozen Organic Whole Beans, 10-oz., UPC code 8 7366800141 (78472) | NATURES TOUCH FROZEN FOODS LLC | Food | Class II | 1 |
| 1 Nov 2017 | NATURAL MIREPOIX FLAVOR 181.4 kgs/drum Ingredients: Carrot Juice, Celery Juice Concentrate, Dextrose, Autolyzed Yeast Extract, Onion Juice Concentrate, Cabbage Juice Concentrate, Salt, Natural Flavoring Givaudan Flavors Corporation 9500 Sam Neace Drive Florence, KY 41042 | Givaudan Flavours Corp | Food | Class II | 1 |
| 1 Nov 2017 | Dark Chocolate Almonds packaged in: 4 oz. Plastic Pouch, 9 oz. Plastic Cup, 9 oz. Stand Up Plastic Pouch, 12 oz. Square Plastic Tub, 17 oz. Family Size Plastic Pouch. Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Decicco s, Graul s Market, Gourmet Garage, Harvest… | Aurora Products, Inc. | Food | Class II | 5 |
| 31 Oct 2017 | Astor Chocolate Corporation Brand Dark Chocolate Covered Cranberries in Astor or Customer Logo packaging a. 1 oz. giveaway type package sizing b. 4 oz. giveaway type package sizing c. No best by date on units d. Individual cases sold to Astor branded customers i. Case counts include cases of: 1. 36 units 2. 50 units… (78436) | Astor Chocolate Corp. | Food | Class II | 1 |
| 31 Oct 2017 | Dried Dark Chocolate Covered Cherries, The products are packaged in 25-pound corrugated boxes and 6 oz. and 24 oz. stand-up pouch packaging. | Shoreline Fruit, LLC | Food | Class II | 2 |
| 31 Oct 2017 | (1)Setton Farms Deluxe Dark Chocolate Almonds 20oz. plastic tubs UPC: 034325078741 (2) Setton Farms Deluxe Dark Chocolate Almonds 14oz . plastic stubs UPC:034325747661 | Setton International Foods Inc | Food | Class II | 2 |
| 31 Oct 2017 | Monarch Worcestershire Sauce, Net 1 gallon, Distributed by US Foods, Inc. Rosemont, IL, packaged in plastic jugs. | CFS West Holdings Inc | Food | Class I | 5 |
| 31 Oct 2017 | dark chocolate peanuts, 8.5 oz. (78432) | Individual firm, name withheld | Food | Class II | 1 |
| 31 Oct 2017 | Woodstock Dark Chocolate Almonds, 8/8.5oz. | United Natural Trading Inc. dba Woodstock Farms | Food | Class I | 6 |
| 30 Oct 2017 | Plum 360 Infusion System, List number 30010. | ICU Medical Inc | Device | Class II | 1 |
| 30 Oct 2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 30 Oct 2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023 (78404) | Individual firm, name withheld | Drug | Class III | 1 |
| 30 Oct 2017 | Dark Chocolate Espresso Beans: CVS Gold Emblem DARK CHOCOLATE ESPRESSO BEANS 2.25oz (64g) UPC: 0504428576601; Candy Break Dark Chocolate Espresso Beans 2.75oz (78g), UPC:024354650049; Hannaford Excellent Espresso Beans 2.75oz (78g), UPC: 041268206414; Market Basket Dark Chocolate Espresso Bean 3oz (85g), UPC:… | New American Food Products, LLC DBA American Foods | Food | Class II | 4 |
| 30 Oct 2017 | Dark Chocolate Almonds; Packaged in 11 oz. pre-packed plastic cups; UPC: 6-51433-66300-5 Also sold in 20 lb. bulk. Sold in bulk bins at Albertsons/Safeway/Vons/Pak 'N Save) - PLU 21881; UPC: 6-51433-10004-3 Bulk bins at Nugget Markets - PLU 6630; UPC: 6-51433-10004-3 Ingredients: Dark Chocolate (sugar, chocolate… (78417) | DSD MERCHANDISER INC | Food | Class II | 1 |
| 30 Oct 2017 | Harmless Coconut Probiotics Original; Coconut Cultured Beverage; UPC 859078-002542; Keep refrigerated 11 lf. oz. HDPE Bottle Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, live and active cultures. Harmless Harvest | Individual firm, name withheld | Food | Class II | 4 |
| 30 Oct 2017 | 21st CENTURY SNACK FOODS DARK CHOCOLATE ALMONDS Roasted Almonds Covered in Rich Dark Chocolate Net Wt. 6oz (170g) UPC: 0 30603 22854 9. (78410) | 21ST CENTURY SNACK FOODS | Food | Class II | 1 |
| 30 Oct 2017 | Market District Coffee Beans covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809 | Giant Eagle, Inc. | Food | Class II | 3 |
| 28 Oct 2017 | Day of the Dead Truffle Cake Pops in a 10-oz. box, SKU: 162622 (78416) | Veronica's Treats, Inc. | Food | Class II | 1 |
| 28 Oct 2017 | MEIJER BULK DARK CHOCOLATE ALMONDS 18 OZ, Clear plastic clam-shell,12 packages per case | Meijer Distribution, Inc | Food | Class II | 3 |
| 27 Oct 2017 | Dark Chocolate Almond, 12/10 oz., 12/18 oz., 18/14 oz., 8/10 oz., 12/8 oz., 8/8 oz., 18 pc., | GKI Foods, LLC | Food | Class II | 21 |
| 26 Oct 2017 | Frosted Pumpkin Drop Cookies; 2-oz.; sold in clear plastic clamshell container with PLU number 024767; UPC 24767000000 | Whole Foods Market | Food | Class I | 1 |
| 26 Oct 2017 | Wegmans Marshmellow Treat sold by the pound UPC: 2-08012-00000 | Wegmans Food Markets, Inc. | Food | Class II | 7 |
| 25 Oct 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 | Fagron, Inc | Drug | Class II | 1 |
| 25 Oct 2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 25 Oct 2017 | Cheesey Bacon Dip, Muriel's brand, dry mix, packaged in 1 pint glass jar. Cheesey Bacon Dip, Muriel's brand, dry mix, packaged in plastic bag, net wt. 1 oz. The label is read in parts: "***Ingredients: Onion, Bacon Bits (Soy Flour, Salt, Caramel Color, Soybean Oil), Powdered Cheese (Maltodextrin, Tapioca Starch,… | E & E Enterprises | Food | Class II | 2 |
| 24 Oct 2017 | smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL | Smith & Nephew, Inc. | Device | Class II | 1 |
| 24 Oct 2017 | AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. | Windstone Medical Packaging, Inc. | Device | Class II | 1 |
| 24 Oct 2017 | Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01 | Amerisource Health Services | Drug | Class II | 1 |
| 24 Oct 2017 | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA | Ace Surgical Supply Co., Inc. | Drug | Class II | 1 |
| 24 Oct 2017 | Chicken of the Sea Pasteurized Crabmeat Lump Blend, Item #411820; Chicken of the Sea Pasteurized Crabmeat Claw, Item #370810; Jack's Catch Pasteurized Crabmeat Jumbo Lump Item #193980; Jack's Catch Pasteurized Crabmeat Lump, Item #199830. All packaged in 1 LB or 16 OZ tin cans. (78365) | Performance Food Group, Inc. | Food | Class II | 1 |
| 23 Oct 2017 | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove. | Medline Industries Inc | Device | Class II | 1 |
| 21 Oct 2017 | Earthbound Farm¿ Organic Chopped Asian Style Salad Kit; 11 oz. bag; (Salad and toppings 8.5 oz {241g} dressing 2.41 fl. oz. [71 mL]). Ingredients: Cabbage, Romaine lettuce, Kale, Carrots, Cilantro, Crunchy toppings and Tahini Dressing. UPC 32601 95134 Earthbound Farms, San Juan Bautista, CA 95045 (78341) | Earthbound Farm, LLC | Food | Class I | 1 |
| 21 Oct 2017 | ASIAN PASTA SALAD Ingredients: Cooked Pasta, Broccoli, Green Onion, Red Onion, Bell Peppers, Cashews, Peanuts, Carrots, Red Cabbage and Asian Salad Dressing Contains: Wheat, Cashews, Peanuts, Soy | The Kroger Co | Food | Class I | 4 |
| 21 Oct 2017 | Tres Latin Foods Kale & Pinto Bean pupusas Stuffed Corn Tortillas, Net Wt. 10 oz. (283g), UPC 854430002475, Keep Frozen [4] 2.5 oz Pupusas. Vegan. Gluten Free. Packaged in carton. | Tres Latin Foods | Food | Class I | 2 |
| 20 Oct 2017 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction. | Shippert Medical Technologies | Device | Class II | 1 |
| 20 Oct 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO | Terumo BCT, Inc. | Device | Class II | 2 |
| 20 Oct 2017 | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary | Terumo BCT, Inc. | Device | Class II | 1 |
| 20 Oct 2017 | H-E-B Asian Noodle Cup Beef 24 oz. packaged in a plastic cup with a plastic insert and plastic lid. | HEB Grocery Company | Food | Class II | 2 |
| 20 Oct 2017 | Carnival Cauli Florets, 6/16 oz., RETAIL item # 73633, New Seasons Market brand, UPC 10200 24467. Ingredients: Green Cauliflower, Orange Cauliflower, Purple Cauliflower, White Cauliflower. | Pacific Coast Fruit Company | Food | Class I | 9 |
| 20 Oct 2017 | BAY CITIES PRODUCE VEGETABLE BLEND POWER SB; Identifier # 46000004927, 1 lb. container | Whole Foods Market | Food | Class I | 3 |
| 20 Oct 2017 | Vegetable products including: BROCCOLI FLORETS 3 LB BROCCOLI FLORETS LB BROCCOLI FLORETS PLU 4548 PRE-PACKAGED BROCCOLI FLORETS BROCCOLI FLORETS 3 LB BAG | Meijer Distribution, Inc | Food | Class I | 11 |
| 20 Oct 2017 | BrightFarms Baby Spinach (4 oz. and 8 oz., and 3# packages) | Individual firm, name withheld | Food | Class II | 9 |
| 20 Oct 2017 | Asparagus Salad Kit, Produced by CP Fresh of Seattle, WA, 1 x 5 lb. per case, UPC 45009 85722 4. The ingredients are: ASPARAGUS, NAPPA CABBAGE, RED PEPPERS, CARROTS, RED ONIONS, BROCCOLI, SNAP PEAS. | Triple B Corporation | Food | Class I | 11 |
| 20 Oct 2017 | Cauliflower Chopped, 8 oz. UPC 24105000000 Sold in Albertson's and Safeway Stores packed in clear plastic trays and cups. | Albertsons Inc | Food | Class I | 23 |
| 19 Oct 2017 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29 | SCA Pharmaceuticals, LLC | Drug | Class II | 10 |
| 19 Oct 2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612.. | Allergan Sales, LLC | Drug | Class III | 2 |
| 19 Oct 2017 | Paragon Wholesale Foods, Warrendale, PA 15086 Label: Paragon; Best if used by 10/16/17; Broccoli Florets 1/2 Cup 50/1.7 oz.; X0011932 17279; UPC: 86870 03200 AND Paragon; Best if used by: 10/23/17; Broccoli Florets 1/2 Cup 50/1.7 oz.; X0012592 17286; UPC: 86870 03200 Bulk: Paragon Wholesale Foods, Warrendale, PA… (78346) | Paragon Foods | Food | Class I | 1 |
| 19 Oct 2017 | Giant Eagle Breaded Shrimp Pittsburgh, PA 15238 PLU # 86815 refrigerated, packed in plastic clam shell. Sell by dates: up to and including Oct 25 2017. Located in the Grab "n Go refrigerated cases at Giant Eagle and Market District supermarkets. | Giant Eagle, Inc. | Food | Class I | 1 |
| 19 Oct 2017 | Apple Valley Honey Roasted Crunch, 15 lb. poly bag lined brown cardboard cases for bulk Item number: 5537606 UPC: 0 23637 02018 0 | First Source, LLC | Food | Class II | 1 |
| 19 Oct 2017 | Mann's Family Favorites Broccoli Carrots, 12 oz. bags UPC 716519013058 - US HEB brand - 12 oz. bag UPC 4122097508 | Mann Packing Company, Inc. | Food | Class I | 44 |
| 19 Oct 2017 | Ready. Chef. Go! Flounder Fillet; UPC 231495 Items are made in store with generated scale label; sold as single, packaged items from refrigerated cases in the meat/seafood department or from mobile refrigerated merchandise cases. The scale label denotes the net weight of each product. | Albertsons Inc | Food | Class II | 18 |
| 18 Oct 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50 | Bioseal Corporation | Device | Class II | 1 |
| 18 Oct 2017 | NucliSENS Lysis Buffer Extended lot for RES 76675 | BioMerieux SA | Device | Class II | 1 |
| 18 Oct 2017 | Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog… | Teleflex Medical | Device | Class II | 1 |
| 18 Oct 2017 | Thanlwin Fried Bean Snack, Net Weight 227 g 8 oz.. UPC 84682-00095 Product of Myanmar. (78318) | Myanmar Wholesale Trading | Food | Class I | 1 |
| 17 Oct 2017 | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) | 3M Company - Health Care Business | Device | Class II | 1 |
| 17 Oct 2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 17 Oct 2017 | Stonyfield ORGANIC O'soy Strawberry on the bottom SOY YOGURT 5.3 Oz (150g), UPC Codes: 0-52159-00603-7. KEEP REFRIGERATED (78316) | Individual firm, name withheld | Food | Class I | 1 |
| 17 Oct 2017 | Weis, Sunbury, PA; BLT Sandwich; 1 CT | Weis Markets, Inc., Ice Cream Division | Food | Class I | 1 |
| 16 Oct 2017 | Newport -Yellowfin Tuna Loin; (3/5 lbs. and 5/8 lbs.) Frozen, packed in 30 lb. (480 oz.) 13.61 KG cardboard box. Product of Indonesia. Ingredients: Yellowfin tuna (fish), Water, carbon monoxide (for color retention). | RELISH FOODS, INC. | Food | Class I | 2 |
| 16 Oct 2017 | Triple Chocolate Mudslide Cookie, 120 1 oz. cookies, frozen | Midway Specialty Vehicles LLC | Food | Class II | 9 |
| 13 Oct 2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01. | Sanofi-Aventis U.S. LLC | Drug | Class III | 1 |
| 13 Oct 2017 | Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40 | PharMEDium Services, LLC. | Drug | Class II | 1 |
| 13 Oct 2017 | taste of Inspirations Classic Red Skin Potato Salad; Net Wt. 16 oz.,; Sell By: 10-20-2017 (top label). taste of Inspirations Rotini Salad; Ingredients: Rotini Pasta ect. Contains: Whey; Distributed by: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074; Keep Refrigerated; (side and bottom label); | ASK Foods Inc | Food | Class I | 1 |
| 13 Oct 2017 | Whole Foods Hand Pie Apple Cinnamon 3 PK, NET WT 8 oz. PLU number 23646100000 | Whole Foods Market | Food | Class I | 1 |
| 13 Oct 2017 | Sun-Dried Tomato Polenta, Melissa's brand, Shelf stable, 12/16 oz package UPC# 0-45255-11848-3 Ingredients: Water, Organic Cornmeal, Organic Sun-Dried Tomatoes, Organic Tomato Powder, Salt, Yeast Extract, Organic Granulated Onion, Tartaric Acid, Ascorbic Acid, Beta Carotene | San Gennaro Foods, Inc | Food | Class III | 14 |
| 13 Oct 2017 | 038267 - Wegmans Cheese Danish Twist, 13 oz. UPC: 0 77890 38267 7 | Wegmans Food Markets, Inc. | Food | Class II | 6 |
| 12 Oct 2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01. | Genzyme Corporation | Drug | Class III | 1 |
| 12 Oct 2017 | Icybay Brand Frog Legs, 4/6 Ct / Lb Farm Raised Trimmed, Frozen. 30 lb. Master Carton (5 lb. inner boxes 6 boxes per master case) UPC Codes: 073129282770 | Slade Gorton & Company, Inc. | Food | Class II | 1 |
| 11 Oct 2017 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various… | Spacelabs Healthcare, Ltd. | Device | Class I | 1 |
| 11 Oct 2017 | VITEK2 GP-ID, REF 21342 IVD | Biomerieux Inc | Device | Class II | 1 |
| 11 Oct 2017 | SKU 57879, Trader Joe's Organic Tomato & Roasted Red Pepper Soup, packaged in a Tetra Pak aseptic container/carton. There are 12 cartons per case. Net Wt. 32 fl. oz. UPC 00578790. Item # 52603-05405, Pacific Organic Roasted Red Pepper and Tomato Soup Canadian, packaged in a Tetra Pak aseptic container/carton. There… (78266) | Pacific Foods of Oregon, Inc. | Food | Class II | 1 |
| 11 Oct 2017 | Kenny's Buckeye Pie, Net Wt.22 oz. (624g). (78313) | Kenny's Great Pies, Inc. | Food | Class II | 1 |
| 10 Oct 2017 | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | Medline Industries Inc | Device | Class II | 2 |
| 10 Oct 2017 | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog… (78289) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Oct 2017 | Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601 | Banner Pharmacy Services, LLC | Drug | Class II | 14 |
| 9 Oct 2017 | Spicely Organics Organic Tarragon 0.4oz. (11g) UPC codes: 8 26998 04106 7 (78269) | Organic Spices, Inc | Food | Class I | 1 |
| 9 Oct 2017 | Cascadian Farm Organic Cinnamon Raisin Granola, Net Wt 15.6 oz (442g). UPC 21908-74329 | General Mills, Inc | Food | Class I | 1 |
| 6 Oct 2017 | Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case. | Halyard Health, Inc | Device | Class II | 9 |
| 6 Oct 2017 | A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014 (78235) | Kiriko, LLC. | Drug | Class II | 1 |
| 6 Oct 2017 | Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15. | AVKARE Inc. | Drug | Class II | 1 |
| 6 Oct 2017 | American Accent Shredded Imitation Mozzarella Cheese, Net Wt. 32 oz. (2lbs) 907g. UPC 36514-28012 Keep Refrigerated. Distributed by Great Lakes Cheese Co. Inc., Hiram, Ohio 44234. | Great Lakes Cheese Co Inc | Food | Class II | 1 |
| 6 Oct 2017 | 365 Organic Raisin Bran Flakes 15 oz. packaged in plastic bag, then cardboard box | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 6 Oct 2017 | GREAT AMERICAN DELI PREMIUM CHICKEN SALAD WHEATBERRRY sandwiches are packaged in a flexible plastic containers, NET WT. 6.4 oz (181g), Great American Deli, PO Box 27, Ooltewah, TN 37363 UPC 7 41431 00228 6 (78241) | Great American Deli, LLC | Food | Class I | 1 |
| 6 Oct 2017 | Cheesy Breadsticks, 9.98 oz. 24 or 25 units per case, or 22.75 oz. 12 units per case, frozen | Champion Foods, LLC | Food | Class II | 6 |
| 6 Oct 2017 | Toma Celena, A nutty, complex, alpine table cheese. All package sizes are subject to the recall and the plant number on the label is 36-8524. | Cooperstown Cheese Company, LLC | Food | Class I | 3 |
| 5 Oct 2017 | WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO | Teleflex Medical | Device | Class II | 1 |
| 5 Oct 2017 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 (78229) | Purdue Pharma, LP | Drug | Class II | 1 |
| 5 Oct 2017 | Deep Dish pre mix dough (78249) | Blue Line Food Service Distribution | Food | Class III | 1 |
| 4 Oct 2017 | RESONATE EL ICD VR, Model D432, Sterile. | Boston Scientific Corporation | Device | Class II | 5 |
| 3 Oct 2017 | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic… | Arthrex, Inc. | Device | Class II | 1 |
| 2 Oct 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1… | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Oct 2017 | Sid Wainer & Son Jansal Valley brand Dried Chili De Arbol Peppers,packaged in a plastic clamshell container 1 ounce size | Friendly Fruit Market dba Sid Wainer & Son | Food | Class II | 1 |
| 29 Sep 2017 | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems. | Abbott Laboratories, Inc | Device | Class II | 2 |
| 29 Sep 2017 | ENLIGHTENED THE GOOD-FOR-YOU ICE CREAM 60 CALORIES PER SERVING PINA COLADA MORE PROTEIN. LESS SUGAR 1 PINT LOW FAT ICE CREAM, UPC 8 52109 33108 6. KEEP FROZEN. (78208) | Beyond Better Foods Llc | Food | Class II | 1 |
| 29 Sep 2017 | (1) Walgreens NICE Egg Salad on White Bread, 6.1 oz (2) Turkey Hill Fresh Selects Egg salad on Homestyle Bread,4.7 oz (3)Target Egg salad on White Bread, 5.9 oz. (4) American Food and Vending Enza Choice Egg Salad on White Bread,4.7 oz Packaged in plastic wedge container. | Greencore USA, LLC | Food | Class I | 5 |
| 28 Sep 2017 | FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire… | Sorin Group USA, Inc. | Device | Class II | 1 |
| 28 Sep 2017 | Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 | Leading Pharma, LLC | Drug | Class II | 1 |
| 27 Sep 2017 | Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and… (78302) | WalkMed, LLC | Device | Class II | 1 |
| 25 Sep 2017 | Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure. | Resource Optimization & Innovation Llc | Device | Class II | 1 |
| 25 Sep 2017 | GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta. | W L Gore & Associates, Inc. | Device | Class II | 1 |
| 25 Sep 2017 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and… | Smiths Medical ASD Inc. | Device | Class II | 3 |
| 25 Sep 2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080. | Precision Dose Inc. | Drug | Class III | 1 |
| 25 Sep 2017 | Instant Reishi Coffee, 4 in 1; Ca Phe Ling Chi; 20 sachets, Net Wt. 360g (12.7 oz.) UPC 8 93663 00225 8 Ingredients: Sugar, Non Dairy Creamer, Instant Coffee, Reishi Extract. Chun Yuen Trading, So. El Monte, CA (78198) | Chun Yuen Trading Co., Inc. | Food | Class I | 1 |
| 22 Sep 2017 | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 21 Sep 2017 | 2.0-oz. Cinnamon Mini Loaf, shipped in 20-count trays. (78180) | Uptown Bakeries | Food | Class II | 1 |
| 20 Sep 2017 | Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 20 Sep 2017 | Item #013 - Fried Pollock Balls Net Weight: 227g 8oz (0.5lb), UPC 6 16641 46438 7; Fried Pollock Balls NETWEIGHT: 2.27kg (5lb) x 5 UPC 8 15655 01066 9; Fish Balls Net Weight: 9 oz (0.56 lb) 8 15655 01041 6; Item # 014 - Pollock Fish Balls Net Weight: 227g 8 oz (0.5lb) UPC 6 16641 46439 4; 014-5X5 Fish Balls… | America New York Ri Wang Food Group Co. Ltd. | Food | Class I | 6 |
| 19 Sep 2017 | Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX. | Exactech, Inc. | Device | Class II | 34 |
| 18 Sep 2017 | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory… | MicroPort Orthopedics Inc. | Device | Class II | 1 |
| 18 Sep 2017 | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 15 Sep 2017 | EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is… | Encore Medical, Lp | Device | Class II | 2 |
| 15 Sep 2017 | ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11 | Becton Dickinson & Company | Drug | Class II | 1 |
| 15 Sep 2017 | Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58 | Baxter Healthcare Corporation | Drug | Class I | 1 |
| 15 Sep 2017 | Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium, Bottled under the authority of Dr. Pepper/Seven up Inc. Plano TX. packed in 2 liter bottles, 0.5 liter bottles, and 12 oz cans. (78135) | Individual firm, name withheld | Food | Class II | 1 |
| 14 Sep 2017 | smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 13 Sep 2017 | Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC #… | Vi-Jon, Inc. | Drug | Class III | 1 |
| 11 Sep 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601 | United Therapeutics Corp. | Drug | Class II | 1 |
| 10 Sep 2017 | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T) | Medtronic Inc. | Device | Class II | 5 |
| 8 Sep 2017 | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System (78109) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Sep 2017 | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers | Sysmex America, Inc. | Device | Class II | 1 |
| 8 Sep 2017 | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33 | AbbVie Inc. | Drug | Class III | 2 |
| 6 Sep 2017 | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S | Biosense Webster, Inc. | Device | Class II | 5 |
| 5 Sep 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90. | Aidarex Pharmaceuticals LLC | Drug | Class III | 1 |
| 5 Sep 2017 | Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10 (78074) | Llorens Pharmaceutical Corp. | Drug | Class II | 1 |
| 1 Sep 2017 | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's. (78037) | Aaren Scientific Inc. | Device | Class II | 1 |
| 1 Sep 2017 | Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03 | Pharmedium Services, LLC | Drug | Class II | 15 |
| 31 Aug 2017 | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow… | ICU Medical, Inc. | Device | Class II | 1 |
| 31 Aug 2017 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7 | Amneal Pharmaceuticals LLC | Drug | Class II | 1 |
| 29 Aug 2017 | PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4. (78051) | Lucky Mart Inc. | Drug | Class I | 1 |
| 29 Aug 2017 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01 | Amerisource Health Services | Drug | Class III | 1 |
| 23 Aug 2017 | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware (78254) | North Star Imaging Inc | Device | Class II | 1 |
| 22 Aug 2017 | No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239 (78257) | Shata Trading, Inc. | Drug | Class II | 1 |
| 22 Aug 2017 | Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03; | Wockhardt Usa Inc. | Drug | Class III | 1 |
| 14 Aug 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue (78092) | Edap Technomed Inc. | Device | Class II | 1 |
| 11 Aug 2017 | Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as… | Invivo Corporation | Device | Class II | 1 |
| 10 Aug 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box. | Medline Industries Inc | Device | Class II | 2 |
| 10 Aug 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose… (78087) | Nucletron BV | Device | Class II | 1 |
| 8 Aug 2017 | Alcon Custom Pak | Alcon Research, LTD. | Device | Class II | 1 |
| 3 Aug 2017 | Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation. | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Aug 2017 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. | OriGen Biomedical, Inc. | Device | Class I | 1 |
| 24 Jul 2017 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter | Epimed International | Device | Class II | 3 |
| 13 Jul 2017 | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. (77754) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Jun 2017 | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of… | Encore Medical, Lp | Device | Class II | 4 |
| 22 Jun 2017 | MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7. (77841) | Vitility | Drug | Class I | 1 |
| 24 May 2017 | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically. | Northgate Technologies, Inc. | Device | Class II | 1 |
| 22 May 2017 | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 May 2017 | Henning's Wisconsin Cheese Colby Jack, Colby & Monterey Jack Blended Together. Packaged in 1 lb., 2 lb, and mammoth wheels (A mammoth wheel can be classified as anything 75 lbs. and larger). (77242) | Henning Cheese, Inc. | Food | Class II | 1 |
| 25 Apr 2017 | Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 1 Apr 2017 | Wegmans Original Killer Brownies with Pecans, UPC Number 2-08184-00000. The product is sold pre-packaged by the pound in a plastic clamshell, or individually on the self-serve cookie bar, in the Bakery Department at Wegmans stores. | Wegmans Food Markets, Inc. | Food | Class I | 4 |
| 27 Jan 2017 | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960 | Becton Dickinson & Company | Device | Class II | 1 |
| 29 Jul 2016 | ROSA BRAIN 3.0.0 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 20 Jul 2016 | ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 27 May 2016 | ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 8 Apr 2016 | ROSA Surgical Device 2.5.8 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 6 Nov 2014 | ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 4 Jun 2014 | ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 14 Feb 2014 | ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 18 Dec 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 5 Feb 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 19 Apr 2012 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging… | Zimmer Biomet, Inc. | Device | Class II | 1 |