| 9 Feb 2016 | TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8. | Alcon Research, Ltd. | Drug | Class II | 1 |
| 28 Jan 2016 | Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 27 Jan 2016 | Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15 (73174) | Bonita Pharmaceuticals, LLC | Drug | Class II | 1 |
| 26 Jan 2016 | Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose) | Amerisource Health Services | Drug | Class III | 1 |
| 25 Jan 2016 | Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter. | Sorin Group USA, Inc. | Device | Class II | 1 |
| 22 Jan 2016 | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation… | Accuray Incorporated | Device | Class II | 1 |
| 21 Jan 2016 | Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling… (73141) | Biomet France SARL | Device | Class II | 1 |
| 19 Jan 2016 | Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN… | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 18 Jan 2016 | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin… | Lab Vision Corporation | Device | Class III | 1 |
| 18 Jan 2016 | LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 18 Jan 2016 | Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. | Bausch & Lomb, Inc. | Drug | Class III | 3 |
| 18 Jan 2016 | Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058. | Perrigo Company PLC | Drug | Class II | 2 |
| 18 Jan 2016 | Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. | Amerisource Health Services | Drug | Class II | 1 |
| 15 Jan 2016 | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral… (73098) | Spectranetics Corp. | Device | Class II | 1 |
| 15 Jan 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000… | CareFusion 303, Inc. | Device | Class II | 1 |
| 15 Jan 2016 | Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Abbott's Compounding Pharmacy, Inc. | Drug | Class II | 43 |
| 15 Jan 2016 | Celestial Seasonings Roastaroma Herbal Tea Lot code: Best Before 20DEC17 Pack size: 6 retail units (20 count)/ per case (73082) | Hain Celestial Group | Food | Class II | 1 |
| 14 Jan 2016 | Uncle Buck's Fish Batter Mix Original, packaged in 22 oz. (623 g) plastic bottles, bottle lot #09241505, UPC 09229725284 and packed 12 bottles/case. Bottles were shipped in cases under lot #09241506 and lot #09241507. Produced and Packaged in the USA for Bass Pro Shops By Monogram Food Solutions, LLC, Memphis, TN… (73079) | BlendTech Inc | Food | Class I | 1 |
| 14 Jan 2016 | Pint Umpqua Dairy Cultured Sour Cream, Item no. 03654, net w. 16 oz.; UPC 0 71203 00403 4. Half Pint Umpqua Dairy Cultured Sour Cream, Item no. 03751, net w. 18 oz.; UPC 0 71203 00401 0. | Umpqua Dairy Products Co | Food | Class II | 14 |
| 13 Jan 2016 | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may… (73071) | Resmed Corporation | Device | Class II | 1 |
| 13 Jan 2016 | Glazers Donuts, 3977904033 040337, 6 PK in cardboard bakery box (fresh). | Kwik Trip Bakery | Food | Class II | 11 |
| 11 Jan 2016 | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 11 Jan 2016 | Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 11 Jan 2016 | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. | Horiba Instruments Inc | Device | Class II | 6 |
| 11 Jan 2016 | Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68 | Pfizer Inc. | Drug | Class II | 2 |
| 10 Jan 2016 | Open Nature Whole Grain White Hot Dog Buns; 8 buns; NET WT 12 oz (340 g) UPC 0 79893 11057 8; Distributed by: Lucerne Foods, inc. Pleasanton, CA 94566 Contains: Wheat, milk May Contain egg, milk. | Albertsons Companies, Inc. | Food | Class II | 14 |
| 8 Jan 2016 | API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips. | BioMerieux SA | Device | Class II | 1 |
| 8 Jan 2016 | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 | Philips Medical Systems | Device | Class II | 1 |
| 8 Jan 2016 | SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 8 Jan 2016 | Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). | Orthofix, Inc | Device | Class II | 1 |
| 8 Jan 2016 | Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 8 Jan 2016 | Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC… | Perrigo Company PLC | Drug | Class II | 2 |
| 7 Jan 2016 | Tong Ren Tang Shenjing Shuairuo Wan Herbal Supplement 240 pills UPC Code: 6 904579 129602 Distributed by: Solstice Medicine Company (73019) | Madison One Acme Inc | Food | Class II | 1 |
| 6 Jan 2016 | IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is… | Zimmer Dental Inc | Device | Class II | 13 |
| 6 Jan 2016 | ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China (73046) | Global Healthcare Inc | Device | Class II | 1 |
| 6 Jan 2016 | Bearded Brothers BOLD Coconut Curry Net Wt. 1.5 oz/43 g UPC: 8-50430-00513-5. | Bearded Brothers LLC | Food | Class II | 2 |
| 6 Jan 2016 | Dark Chocolate, Milk Chocolate, & Yogurt Covered cranberries, Net Wt. 5 oz (140g) Packaged under the following names: Cape Cod Cranberry Candy" UPC 6 12681 10259 3 and Harvest Sweets" UPC 6 12681 44259 0. (73011) | Cape Cod Provisions LLC | Food | Class I | 1 |
| 5 Jan 2016 | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. | Salter Labs | Device | Class II | 1 |
| 5 Jan 2016 | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels. | Bard Peripheral Vascular Inc | Device | Class II | 2 |
| 5 Jan 2016 | Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24. | Hospira Inc. | Drug | Class I | 1 |
| 4 Jan 2016 | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation. | C.R. Bard, Inc. | Device | Class III | 1 |
| 2 Jan 2016 | Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as: New Year's Pretzel Sell By: 01/04/2016 PLU: 39739 UPC: 23979 80499 | Giant Eagle, Inc. | Food | Class I | 1 |
| 31 Dec 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 | Sandoz Inc | Drug | Class III | 1 |
| 31 Dec 2015 | Whole cucumbers | FreshPoint Corporate | Food | Class I | 2 |
| 31 Dec 2015 | Little Temptations Sour Strawberries Net Wt. 7.5 oz (213g) Packed by: Crystal Temptations, North Arlington, NJ 07031 UPC 611190469401 (73244) | JNC International Inc. | Food | Class II | 1 |
| 29 Dec 2015 | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. | Radiometer America Inc | Device | Class II | 1 |
| 29 Dec 2015 | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated. (73053) | Pharmacaribe llc | Device | Class II | 1 |
| 29 Dec 2015 | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 28 Dec 2015 | EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and… | Phadia Ab | Device | Class II | 1 |
| 24 Dec 2015 | BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast). | bioMerieux, Inc. | Device | Class II | 2 |
| 24 Dec 2015 | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | Viewray Incorporated | Device | Class II | 1 |
| 24 Dec 2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10. | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 23 Dec 2015 | Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038. | MOOG Medical Devices Group | Device | Class II | 1 |
| 23 Dec 2015 | GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images. | GE Medical Systems, LLC | Device | Class II | 3 |
| 23 Dec 2015 | APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7. (73016) | Nuway Distributors, LLC | Drug | Class I | 1 |
| 23 Dec 2015 | Mandarin Oranges (In Light Syrup), Net Wt. 8oz (227g), Case UPC#: 100-49022-80895-6, Product UPC#: 0-49022-80895-9 | Milky Way Intl Trading Corp | Food | Class II | 1 |
| 23 Dec 2015 | Signature Cafe Traditional Stuffing; Turkey Broth, Seasoned Bread Crumb Mix, Celery, Yellow Onion. Net WT. 39 oz. (2 lbs 7 oz) 1.1 kg. Perishable, Keep refrigerated. UPC 21130-08320 Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566 (72932) | Taylor Farms Pacific, Inc. | Food | Class I | 1 |
| 22 Dec 2015 | Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support. | Draeger Medical, Inc. | Device | Class I | 2 |
| 22 Dec 2015 | Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System | Cook Medical Incorporated | Device | Class II | 1 |
| 22 Dec 2015 | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays. | Bio-Rad Laboratories, Inc. | Device | Class II | 1 |
| 21 Dec 2015 | Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF) | Baxter Corporation Englewood | Device | Class II | 1 |
| 21 Dec 2015 | ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into… | Acist Medical Systems | Device | Class II | 1 |
| 21 Dec 2015 | This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090 (72909) | Individual firm, name withheld | Food | Class II | 1 |
| 21 Dec 2015 | Zzang! Original Candy Bar, 2.5 oz., packaged in preprinted cardboard boxes, UPC 8 44397 00014 0 | Zingerman's Candy Manufactory | Food | Class II | 5 |
| 20 Dec 2015 | Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box | Signature Breads, Inc. | Food | Class II | 10 |
| 18 Dec 2015 | Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ | GE Medical Systems, LLC | Device | Class II | 1 |
| 18 Dec 2015 | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate | Instrumentation Laboratory Co. | Device | Class II | 1 |
| 18 Dec 2015 | Fuse 1C Colonoscope (73067) | EndoChoice, Inc. | Device | Class II | 1 |
| 17 Dec 2015 | RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E,… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 17 Dec 2015 | Dove Chocolate Assortment Snowflakes Net. Wt. 24.0 oz. Distributed by Mars Chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 400050521 | Mars Chocolate North America | Food | Class I | 1 |
| 17 Dec 2015 | Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL, NET WT 8 OZ, UPC 7142909849 (72883) | Zatarain's Partnership, L.P. | Food | Class I | 1 |
| 16 Dec 2015 | Masago Lake Smelt Roe 6 oz. UPC Code:4866010101 | Ocean Group Inc. | Food | Class I | 1 |
| 15 Dec 2015 | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 15 Dec 2015 | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis. | Bio-Rad Laboratories, Inc. | Device | Class II | 1 |
| 15 Dec 2015 | Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile. (72904) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Dec 2015 | Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 14 Dec 2015 | Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position… (72937) | Individual firm, name withheld | Device | Class II | 1 |
| 14 Dec 2015 | Tonkutsu Ramen, Net Wt. 12 oz. Made by Sun Noodle Honolulu, HI 96819/Rancho Domingo, CA 90220/Teterboro, NJ 07605 UPC 0 85315 40003 5 PACKAGED IN PLASTIC CLEAR CLAMSHELL (72847) | Sun Noodle New Jersey, LLC | Food | Class I | 1 |
| 14 Dec 2015 | Dried Tai Sweet Mango Slice, Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882 UPC 6 944155 210102 | AA USA Trading Inc. | Food | Class I | 2 |
| 10 Dec 2015 | FATwater bottle, 16.9 fl. oz., Berry flavor, UPC 6 09015 50477 2 | Bulletproof Digital Inc | Food | Class III | 3 |
| 10 Dec 2015 | Label reading in part: "CRIADA***PREMIUM GANDULES VERDES GREEN PIGEON PEAS***In water with salt*** NET WT. 15 oz (425g)***Producido para/Produced for Empresas La Famosa, Inc.: P.O. Box 51968 Toa Baja, P.R. 00949***Product of Peru/Producto de Peru". | A.R.Food Brokerage Corp. | Food | Class II | 2 |
| 5 Dec 2015 | Dockside Classics 4 Premium Crab Cakes Net Wt. 12 oz. UPC: 045425165446 | Albertsons Llc | Food | Class II | 2 |
| 4 Dec 2015 | Sunbest Natural Lemon Juice 33.5 Fl. Oz. Distributed by Sunco & Frenchie LLC Clifton, NJ 07011 UPC 089625403007 | SUNCO & FRENCHIE LLC. | Food | Class II | 1 |
| 3 Dec 2015 | VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department. | Del Medical, Inc. | Device | Class II | 2 |
| 2 Dec 2015 | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of… | Medtronic | Device | Class II | 4 |
| 1 Dec 2015 | PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery. (73007) | JosNoe Medical, Inc. | Device | Class II | 1 |
| 27 Nov 2015 | Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 25 Nov 2015 | Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. | Richard Wolf Medical Instruments Corp. | Device | Class II | 3 |
| 25 Nov 2015 | B&D Seafoods Basa Choice Swai Fillets IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11 lbs 2/case (size 6-8) Farm Raised Distributed by B&D Seafoods, Inc. Product of Vietnam IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes. | B & D Seafoods Inc | Food | Class III | 3 |
| 24 Nov 2015 | WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar, NET WT 11.75 OZ (333 g) | Thai Culinary Arts Studio LLC | Food | Class II | 3 |
| 18 Nov 2015 | MEVION S250 Radiation therapy system | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 17 Nov 2015 | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use. | Owens & Minor Distribution, Inc. | Device | Class II | 3 |
| 17 Nov 2015 | Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI, NET WT 9 OZ, UPC #77890 36434, KEEP REFRIGERATED, PRODUCT OF ITALY | Wegmans Food Markets, Inc. | Food | Class I | 1 |
| 13 Nov 2015 | Marky's Puto Seko Special, Net Wt. 200 GMS (72884) | Lee'S Food Corp | Food | Class II | 1 |
| 11 Nov 2015 | SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5. | Fagron, Inc | Drug | Class II | 3 |
| 10 Nov 2015 | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. | C.R. Bard, Inc. | Device | Class II | 1 |
| 6 Nov 2015 | Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476. (72737) | Glades Drugs Inc. | Drug | Class I | 1 |
| 4 Nov 2015 | Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30 | Individual firm, name withheld | Drug | Class III | 3 |
| 3 Nov 2015 | Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. | Philips Electronics North America Corporation | Device | Class II | 2 |
| 3 Nov 2015 | Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). | Philips Electronics North America Corporation | Device | Class II | 29 |
| 2 Nov 2015 | 100% Whole Grain Hot Dog Rolls (72645) | Bake Rite Rolls Divison of Northeast Foods | Food | Class II | 1 |
| 28 Oct 2015 | Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count | Southeastern Grocers Llc | Food | Class I | 3 |
| 21 Oct 2015 | Inclusion chocolate bar 66% Cacao topped with pistachios, cranberries & Sea Salt in a white and green wrapping with white and gray lettering. | E3 Artisan | Food | Class I | 21 |
| 7 Oct 2015 | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 5 Oct 2015 | NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827. (72614) | Inaffit, LLC | Drug | Class I | 1 |
| 5 Oct 2015 | Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products | Sunset Natural Products Inc. | Food | Class II | 10 |
| 1 Oct 2015 | Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. | MSNV, Inc dba National Video Supply | Drug | Class I | 2 |
| 30 Sep 2015 | Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Premiere Sales Group | Drug | Class I | 2 |
| 29 Sep 2015 | Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1. (72874) | Individual firm, name withheld | Drug | Class I | 1 |
| 28 Sep 2015 | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with… | Exactech, Inc. | Device | Class II | 1 |
| 25 Sep 2015 | ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30. | Medline Industries Inc | Drug | Class I | 2 |
| 18 Sep 2015 | MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Sentara Enterprises | Drug | Class II | 34 |
| 3 Sep 2015 | Kraft Singles American packaged in a blue box with white lettering. | The Kraft Heinz Company | Food | Class II | 3 |
| 19 Aug 2015 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Pharmakon Pharmaceuticals | Drug | Class II | 22 |
| 14 Aug 2015 | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 13 Aug 2015 | Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605. | Safecor Health, LLC | Drug | Class II | 1 |
| 5 Aug 2015 | RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111589 | Red Diamond, Inc. | Food | Class II | 3 |
| 22 Jul 2015 | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 13 Jul 2015 | Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida (71733) | Life and More LLC | Drug | Class I | 1 |
| 6 Jul 2015 | Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 22 May 2015 | Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44. | Pharmedium Services, LLC | Drug | Class I | 1 |
| 13 Apr 2015 | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video… | Verathon, Inc. | Device | Class II | 1 |
| 13 Mar 2015 | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 2 Mar 2015 | Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40. | Safecor Health, LLC | Drug | Class II | 1 |
| 13 Jan 2015 | fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium. | Pharmedium Services, LLC | Drug | Class I | 2 |
| 4 Sep 2014 | Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the… (70765) | Midmark Corp dba Progeny Inc | Device | Class II | 1 |
| 29 Aug 2014 | Mung bean sprouts packaged in 10 lb., 15 lb., and 30 lb. plastic bags. (69702) | Wholesome Soy Products | Food | Class I | 1 |
| 14 Aug 2014 | Synthes Small Electric Drive (SED). For use in general traumatology. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 14 Feb 2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901,… | Medisca Inc | Drug | Class I | 1 |
| 30 Jul 2013 | High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule. | Smith & Nephew, Inc., Endoscopy Div. | Device | Class II | 1 |
| 4 Apr 2013 | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument | Smith & Nephew, Inc., Endoscopy Div. | Device | Class II | 2 |
| 19 Jan 2012 | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG) | Nihon Kohden America Inc | Device | Class II | 1 |