| 12 Jun 2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344 | Vi-Jon, Inc. | Drug | Class II | 1 |
| 7 Jun 2017 | joray fruit roll FRUIT PUNCH flavor NET WT 1 OZ. (28g). UPC# 0 51063 50009 9. (77472) | Joseph Shalhoub & Son, Inc. | Food | Class II | 1 |
| 6 Jun 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7. | Bausch & Lomb, Inc. | Drug | Class II | 1 |
| 5 Jun 2017 | Western Family Onion Soup Mix, 2.25 oz. pouches packaged in 4.5-oz. cartons | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 2 Jun 2017 | Southern Grove Cashew Halves & Pieces with Sea Salt, Net Weight 8.0 oz. (227 grams) | Star Snacks Co., Llc. | Food | Class II | 1 |
| 1 Jun 2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401 (77428) | MedPark Pharmacy, LLC | Drug | Class II | 1 |
| 1 Jun 2017 | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12 | L. Perrigo Company | Drug | Class II | 1 |
| 1 Jun 2017 | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA. (77427) | Lucid Pharma LLC | Drug | Class II | 1 |
| 31 May 2017 | Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211) | Philips Electronics North America Corporation | Device | Class II | 1 |
| 31 May 2017 | Blue Diamond Almonds Blanc DCD FN C (blanched diced fine); NET WT 11.34 Kg, 25 lbs. corrugated carton with poly liner; Product of the USA. Blue Diamond Almonds, Sacramento, CA | Blue Diamond Growers | Food | Class I | 1 |
| 26 May 2017 | PRIVATE SELECTION AFRICAN - INSPIRED PERI PERI CHILI CULINARY SPICE PASTE NET WT 4 OZ (113g) UPC 0 11110 80699 4 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 MADE IN CANADA | Monfitello | Food | Class I | 2 |
| 26 May 2017 | NutriHeal OPTIMAL CHOLESTEROL Traditional Vegetarian Blend Herbal Supplement, 60 Tablets. Distributed By: Herbmed USA Company Inc. (77322) | Herbmed USA Company Inc. | Food | Class I | 1 |
| 25 May 2017 | California Sun Dry Sun Dried Tomato Pesto; NET WT. 8.5 oz. (241g) glass jar; Ingredients (incorrect) Garlic, Canola oil, sundried tomatoes (preserved with sulfating agents) water, sola oil, spices, onion, salt, citric acid,, soy lecithin. Partially processed with Genetic Engineering. UPC 7 38203 10911 3 California… (77376) | California Sun Dry Foods | Food | Class I | 1 |
| 24 May 2017 | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 24 May 2017 | Merge OrthoPACS software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 24 May 2017 | D'Allesandro Woodland Foods De-stemmed Birdseye Chiles 1, 5, and 35 lbs., food service, bag in box container, singe unit per case. (77388) | Woodland Foods | Food | Class II | 1 |
| 23 May 2017 | Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are… | Magellan Diagnostics, Inc. | Device | Class I | 2 |
| 23 May 2017 | The Green Herb 100% Natural AL-ER-G, 60 and 150 Capsules, Dietary supplement, This item is packed in a white bottle with a white cap. Each bottle contains 60 or 150 capsules, each capsule is 180 mg of ephedra herb in a 650 mg capsule. Batch#1892; product# 314. (77358) | MusclMasster, LLC | Food | Class I | 1 |
| 22 May 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200 | Creganna Medical Devices | Device | Class II | 4 |
| 22 May 2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 | Individual firm, name withheld | Drug | Class II | 4 |
| 22 May 2017 | Simple truth Dry Roasted Macadamia Nuts SEA SALT 12 oz bag UPC 0 1111 00247 8 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 | The Kroger Co | Food | Class I | 1 |
| 22 May 2017 | Fettuccine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.… | Alaska Pasta Company | Food | Class II | 17 |
| 22 May 2017 | GEC TNT Thermanite 60 Capsules Dietary Supplement in clear plastic bottle, UPC: 689466706222. (77278) | Genetic Edge Compounds LLC | Food | Class II | 1 |
| 22 May 2017 | Master Carton is Labeled As: LOBSTER FLAVORED BALL DISTRIBUTED EXCLUSIVELY BY: H & C FOOD INC. BROOKLYN, NY 11237 KEEP FROZEN AT -18 C | H & C Food Inc | Food | Class I | 1 |
| 19 May 2017 | GE Healthcare Revolution EVO X-ray system | GE Healthcare, LLC | Device | Class II | 16 |
| 19 May 2017 | L.A. LUCKY BRAND SWEET BASIL SEEDS: Hot E 2.1 OZ (60 G) BAGS; 100 BAGS PER CASE; Product of Vietnam. Ingredients: Sweet Basil Seeds Serving Size 1.05 oz. (2 servings per container) Distributed by L.A. Lucky Import & Export, Inc., Bell, CA 90201 (77341) | L.A. Lucky Import & Export | Food | Class I | 1 |
| 19 May 2017 | Hail Merry Meyer Lemon Miracle Mini Tarts, 6 tartlets per tray packaged in clear plastic molded trays. (77368) | Hail Merry LLC | Food | Class II | 1 |
| 18 May 2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC… (77315) | Forest Laboratories, LLC | Drug | Class II | 1 |
| 18 May 2017 | Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04 | Hospira Inc., A Pfizer Company | Drug | Class II | 1 |
| 18 May 2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32. | SCA Pharmaceuticals | Drug | Class II | 10 |
| 17 May 2017 | KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 17 May 2017 | QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for… | Z-Medica, LLC | Device | Class II | 1 |
| 17 May 2017 | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by:… | VistaPharm, Inc. | Drug | Class III | 1 |
| 17 May 2017 | Frozen Yellowfin tuna cubes, random; Individually vacuum packed; 15 lb. case. Product of the Philippines; Brand - Krimson Product; UPC 10664183002946 Ingredient: - Frozen Tuna and tasteless smoke - to promote color retention. Imported by Hilo Fish Company Inc., Honolulu, HI. | Hilo Fish Company Inc | Food | Class I | 2 |
| 17 May 2017 | Bright Farms Basil (.75 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package . | BrightFarms, Inc.: WDC Greenhouse LLC | Food | Class II | 10 |
| 15 May 2017 | CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 13 May 2017 | Oatmeal Chocolate Chip Cookies, 18pk, NET WT. 0 lb 10 oz (283 g), Dist. by Whole Foods Market, 1105 N. Lamar, Austin, TX 78703 USPC 0247181 004992 (77296) | Wholefoods Market | Food | Class I | 1 |
| 13 May 2017 | Bean & Cheddar with Salsa, FIRE ROASTED Corn & Red Bell Pepper Burrito. MILD, Net WT 7oz, Item # 886, Case UPC 833425001464, Item UPC 8 33425 00336 9. Packaged in Paper Wrap sealed with Item Label, 12 units per case. Frozen or refrigerated. | Green Chile Foods, Inc. | Food | Class I | 2 |
| 12 May 2017 | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 5 |
| 12 May 2017 | High Liner Foods, Breaded Haddock Tail Portions 5 oz. | ISF "USA", LLC | Food | Class I | 6 |
| 11 May 2017 | Philips DigitalDiagnost 3.1.x X-Ray System | Philips Electronics North America Corporation | Device | Class II | 1 |
| 11 May 2017 | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation. | Teleflex Medical | Device | Class II | 1 |
| 11 May 2017 | Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 11 May 2017 | Red Robin Burgers and Brews Crispy Onion Rings, frozen, Net wt. 14 ounce. Retail package UPC 0 43301 61119 3. | Lamb Weston Inc | Food | Class I | 1 |
| 11 May 2017 | Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz. packed in a paper carton, keep frozen | Tyson Foods, inc. | Food | Class II | 2 |
| 11 May 2017 | Kite Hill Mushroom and Ricotta Ravioli; frozen Ravioli made with almond milk ricotta: 9 oz. package. UPC 856624004173 Owned and distributed by Lyrical Foods, Hayward, CA. (77263) | Lyrical Foods Inc | Food | Class II | 1 |
| 11 May 2017 | Trident Item # 421048, Multi-Grain Alaskan Cod, Frozen, RETAIL packages, Net wt. 12 oz. UPC 0 28029 21048 4 The retail label is read in parts: "***Trident SEAFOODS***Multi-Grain Alaskan Cod***NET WT. 12 OZ.***". The retail case label is read in parts: "***Trident SEAFOODS***10 Grain Breaded Alaskan Cod***ITEM:… | Trident Seafoods Corp - Island Enterprise M/V | Food | Class II | 8 |
| 10 May 2017 | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017 | Zimmer Biomet Spine Inc. | Device | Class II | 1 |
| 10 May 2017 | Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; | ConvaTec, Inc | Device | Class II | 18 |
| 9 May 2017 | Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only, | Teleflex Medical | Device | Class II | 1 |
| 9 May 2017 | Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system | Roche Diagnostics Corporation | Device | Class II | 1 |
| 9 May 2017 | Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages | Cook Inc. | Device | Class II | 1 |
| 9 May 2017 | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels | Arrow International Inc | Device | Class II | 12 |
| 9 May 2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 9 May 2017 | Denali "Original" Moose Tracks Cheesecake, Net Wt. 18 oz (510g). Black plastic base with clear plastic dome. Back label includes nutrition labeling for Pumpkin Swirl Cheesecake. Manufactured by The Father's Table, LLC | The Father's Table, LLC | Food | Class III | 1 |
| 9 May 2017 | Mikawaya Mochi Ice Cream Chocolate Chocolate, 6-1.5oz (43g) pieces, Net Wt. 9.1oz (258g), UPC 070934990609, 24 boxes/case (77228) | Mikawaya | Food | Class I | 1 |
| 8 May 2017 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 May 2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 May 2017 | Beekley Medical 0-SPOT Mammography Skin Markers REF 652 | Beekley Corporation | Device | Class III | 1 |
| 8 May 2017 | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750. | Medtronic Inc. | Device | Class II | 4 |
| 8 May 2017 | Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 8 May 2017 | Pick 5 Chicken & Waffle Sandwich; Mix & Match, Keep Frozen; Net Wt. 14.4 oz.; Distributed by: Save-A-Lot Food Stores, Ltd., Earth City, MO 63045; UPC: 051933353664 (77226) | Fourth Street Barbeque, Inc. | Food | Class II | 1 |
| 8 May 2017 | Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., 6/case, packed in a stand-up pouch. | Meijer, Inc #816 - Grand River Packaging | Food | Class II | 1 |
| 8 May 2017 | Publix Deli, Artichoke & Spinach dip, 16 oz., plastic clamshell, Manufactured and distributed by Publix Super Markets, Lakeland, FL. | Publix Super Markets, Inc. | Food | Class II | 1 |
| 5 May 2017 | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 5 May 2017 | Infant Warmer System (IWS) | GE Healthcare, LLC | Device | Class II | 1 |
| 5 May 2017 | Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent | Cell Marque Corporation | Device | Class II | 12 |
| 5 May 2017 | Hazelnut Cake, Paradise Deli brand, net wt. 15 oz., UPC 0 31619 10201 4. The label is read in parts: "***Contains: Oregon grown hazelnuts, cane sugar, organic unbleached wheat flour, fresh eggs, sea salt, pure vanilla***PARADISE DELI - PO Box 22411, Eugene, OR 97402 *** 925 37th Eugene, OR 97405***". | Choice Northwest | Food | Class II | 2 |
| 5 May 2017 | Honey Bourbon Pecans Net Wt. 20 lb. (9.088g) Mfg. By: Trophy Nut Co. Tipp City, OH 45371 | Trophy Nut Co Inc | Food | Class II | 1 |
| 5 May 2017 | Spinach Sold under the brand names of Harris Teeter Farmers Market, 10 oz bag, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC 0 72036 88023 9 & Peak 10 OZ & 40 oz bags, PACKED BY THE HORTON FRUIT CO., INC. LOUISVILLE, KY 40218 UPC 0 78951 50002 3 & 30 lb totes (77212) | The Horton Fruit Co Inc | Food | Class I | 1 |
| 5 May 2017 | AUNT JEMIMA(R) LIL' GRIDDLES(TM) BLUEBERRY MINI PANCAKES, 40 COUNT, NET WT 14.5oz UPC 019600054603 | Pinnacle Foods, LLC | Food | Class II | 27 |
| 5 May 2017 | Queso Hondureno, Queso Duro Blando - Honduran Cheese, Dry Hard Cheese; 1 lb 454 g (77222) | La Nica Products, Inc. | Food | Class I | 1 |
| 4 May 2017 | Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. | Applied Medical Resources Corp | Device | Class II | 1 |
| 4 May 2017 | NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) | Philips Electronics North America Corporation | Device | Class II | 1 |
| 4 May 2017 | Robin Hood ENRICHED & PRE-SIFTED ALL PURPOSE flour ORIGINAL, UPC 0 59000 01632 0, 1 kg | Bedessee Imports, Inc | Food | Class I | 1 |
| 4 May 2017 | Tuna King Tuna Steaks 10 oz.. ,10 lb Box. Frozen UPC Codes: 8158380206764 | Northern Fisheries Ltd. | Food | Class II | 1 |
| 3 May 2017 | Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages | Cook Inc. | Device | Class II | 1 |
| 3 May 2017 | Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111;… | Medtronic | Device | Class II | 8 |
| 3 May 2017 | OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation | Cook Inc. | Device | Class II | 1 |
| 1 May 2017 | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. (77176) | Circadiance LLC | Device | Class II | 1 |
| 1 May 2017 | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. | Cook Inc. | Device | Class II | 6 |
| 28 Apr 2017 | VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H | Zimmer Biomet, Inc. | Device | Class II | 8 |
| 28 Apr 2017 | Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be… (77313) | MONICA HEALTHCARE LTD | Device | Class II | 1 |
| 28 Apr 2017 | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes… | KCI USA, INC. | Device | Class II | 1 |
| 28 Apr 2017 | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters | Arrow International Inc | Device | Class II | 1 |
| 28 Apr 2017 | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests (77260) | Exact Sciences Corporation | Device | Class II | 1 |
| 27 Apr 2017 | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | AbbVie Inc. | Device | Class II | 3 |
| 27 Apr 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems. | Randox Laboratories | Device | Class III | 1 |
| 27 Apr 2017 | Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01 | Hetero USA Inc | Drug | Class III | 1 |
| 26 Apr 2017 | Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T (77301) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Apr 2017 | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary… (77131) | Individual firm, name withheld | Device | Class I | 1 |
| 26 Apr 2017 | Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 26 Apr 2017 | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20 | Sandoz Inc | Drug | Class III | 1 |
| 25 Apr 2017 | Pereyra-Raz Ligature Carrier | Cook Inc. | Device | Class II | 5 |
| 25 Apr 2017 | Assist Bed Rail - 6632 | Invacare Corporation | Device | Class II | 1 |
| 25 Apr 2017 | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The… | Vascular Solutions, Inc. | Device | Class I | 1 |
| 24 Apr 2017 | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening. | OrthoPediatrics Corp | Device | Class II | 1 |
| 24 Apr 2017 | STILL RIDING FOODS GLUTEN FREE PIZZA CRUST; Sold in the following package sizes: 36/9" NET WT 15lbs (6.80kg); 12/12" NET WT 10lbs (5.44kg); 24/12" NET WT 27lbs (12.25kg); 18/9" NET WT 7lbs (3.18kg) (77076) | Still Riding Foods, LLC | Food | Class II | 1 |
| 24 Apr 2017 | KRISPPE CLAM-FRY-MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs. | Krisppee Products Co. | Food | Class I | 3 |
| 21 Apr 2017 | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated (77261) | Individual firm, name withheld | Device | Class II | 1 |
| 20 Apr 2017 | VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton. | Biomerieux Inc | Device | Class II | 187 |
| 20 Apr 2017 | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems… | Acumed LLC | Device | Class II | 1 |
| 20 Apr 2017 | Hill Country Fare Thin Sandwich UPC 4122046090; Hill Country Fare Extra Thin Sandwich UPC 4122063420; Good Thin Bread; Good Bread Texas Toast; Clear Prison This; Clear Prison X-Thin all units 24 oz per bag | HEB Retail Support Center | Food | Class II | 5 |
| 19 Apr 2017 | Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01, | Qualgen | Drug | Class II | 8 |
| 18 Apr 2017 | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders. | Abbott Laboratories | Device | Class II | 1 |
| 17 Apr 2017 | Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z (77164) | Individual firm, name withheld | Device | Class II | 1 |
| 17 Apr 2017 | AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 17 Apr 2017 | ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327 | American Pharmaceutical Ingredients LLC | Drug | Class II | 1 |
| 13 Apr 2017 | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435. | Spectrum Laboratory Products, Inc. | Drug | Class II | 2 |
| 13 Apr 2017 | Chocolate chip cookie dough larabars, 10 count , UPC 100-21908-49031 incorrectly packaged in peanut butter cookie larabars boxes, 10 count, UPC000-21908-49154. | General Mills, Inc | Food | Class II | 1 |
| 12 Apr 2017 | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume… | Vascular Solutions, Inc. | Device | Class II | 1 |
| 10 Apr 2017 | Elecsys PreciControl Varia 3 | Roche Diagnostics Corporation | Device | Class II | 1 |
| 7 Apr 2017 | Refrigerated, ready-to-eat, sliced, cold smoked, SMOKED NORWEGIAN SALMON in 4 oz., 8 oz., & whole sides in vacuum packages -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543 | The Smokehouse of New York, LLC. | Food | Class I | 12 |
| 4 Apr 2017 | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye… (77170) | Laserex Systems Inc. | Device | Class II | 1 |
| 31 Mar 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 31 Mar 2017 | AAHU BARAH, DRY FIG, NET WT. 1 LB, PRODUCT OF PAKISTAN | GLOBAL COMMODITIES INC | Food | Class III | 1 |
| 23 Mar 2017 | Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals. | Omega Medical Imaging, Inc. | Device | Class II | 1 |
| 23 Mar 2017 | just Cookie Dough Chocolate Chip, Net Wt 14 oz (397g). Keep Refrigerated. | Choice Products USA, LLC | Food | Class II | 2 |
| 21 Mar 2017 | Dimension Troponin 1 (TNI) Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 6 |
| 20 Mar 2017 | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter… | Arrow International Inc | Device | Class II | 56 |
| 14 Mar 2017 | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex… | Nexstim PLC | Device | Class II | 2 |
| 14 Mar 2017 | Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and… (76808) | Hans Pausch Rontgengeratebau Gmbh | Device | Class II | 1 |
| 28 Feb 2017 | Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants | Zimmer Biomet, Inc. | Device | Class II | 35 |
| 17 Feb 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Pharmedium Services, LLC | Drug | Class II | 11 |
| 9 Feb 2017 | Proteus 235 | Ion Beam Applications S.A. | Device | Class II | 1 |
| 8 Feb 2017 | AIA-PACK TPOAb CONTROL SET | Tosoh Bioscience, Inc. | Device | Class III | 2 |
| 6 Feb 2017 | Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems | GE Healthcare, LLC | Device | Class II | 1 |
| 1 Feb 2017 | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 31 Jan 2017 | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Jan 2017 | Market Basket moreBAR Dark Chocolate Peanut , 4.3 oz. bar (77320) | DeMoulas Supermarket, Inc. | Food | Class II | 1 |
| 6 Jan 2017 | DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 25 Sep 2016 | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 8 Aug 2016 | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 7 Jul 2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280. | Safecor Health, LLC | Drug | Class II | 6 |
| 2 Apr 2016 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014 | Complete Pharmacy and Medical Solutions LLC | Drug | Class I | 1 |
| 23 Mar 2016 | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is… | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 29 Dec 2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014 | Complete Pharmacy and Medical Solutions LLC | Drug | Class I | 1 |
| 23 Dec 2015 | Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000 (76975) | Cardinal Scale Mfg Co | Device | Class II | 1 |
| 30 Nov 2015 | Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples. | Acumedia Manufacturers, Inc. | Device | Class II | 1 |
| 11 Sep 2015 | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk,… | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 23 Oct 2014 | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per… | Medtest Holdings, Inc. | Device | Class III | 1 |
| 28 Apr 2014 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Baxter Healthcare Corporation | Device | Class II | 1 |
| 13 Mar 2012 | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. | Medtest Holdings, Inc. | Device | Class II | 1 |
| 8 Jul 2011 | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. | Medtest Holdings, Inc. | Device | Class II | 1 |
| 11 Jan 2011 | Video Bronchoscope | Pentax of America Inc | Device | Class II | 3 |
| 17 Dec 2010 | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 4 Jun 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty… | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |