| 8 May 2015 | Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 4 May 2015 | GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). | GE Healthcare | Device | Class II | 1 |
| 1 May 2015 | Fetting's Jumbo 2.5 oz Cinnamon Roll Dough 140, Approx. 120 count, Keep Frozen, NET WT 18.8 LB., UPC 0 75812 79140 0, Packaged in plastic liner in cardboard box, Manufactured by Top Taste Inc, Finley, ND 58230.. (71163) | Top Taste, Inc | Food | Class I | 1 |
| 1 May 2015 | Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. | Poco Dolce Confections, Inc. | Food | Class II | 6 |
| 30 Apr 2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23 | Mission Pharmacal Co | Drug | Class II | 2 |
| 29 Apr 2015 | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. | Richard-Allan Scientific Company | Device | Class II | 2 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side). | HeartWare Inc | Device | Class I | 1 |
| 29 Apr 2015 | Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen… | Janssen Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 28 Apr 2015 | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. | Covidien LLC | Device | Class II | 1 |
| 27 Apr 2015 | Raw Pine Nuts sold in the following brands and package sizes: -Good Sense 3 oz. (85g) bag UPC 30243-86681, -Good Sense 4 oz. (113g) bag, UPC 30243-86680, -Good Sense 4 oz. (113g) tub UPC 30243-50799, -Good Sense 15 oz. (425g) bag UPC 30243-86687, -Good Sense 5 lbs. box UPC 30243-02860, -Good Sense 4 oz. bags may have… (71103) | Waymouth Farms, Inc | Food | Class I | 1 |
| 27 Apr 2015 | D&D Foods, Inc. Summer Fresh Pasta 31830, packaged in 8-lb. plastic buckets. The firm name on the label is D&D Foods, Inc., Omaha, NE. | D & D Foods, Inc. | Food | Class I | 1 |
| 24 Apr 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25. | Cipla Limited | Drug | Class III | 1 |
| 24 Apr 2015 | Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607 (70914) | Romark Laboratories, L.C. | Drug | Class II | 1 |
| 23 Apr 2015 | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 23 Apr 2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 | RemedyRepack Inc. | Drug | Class II | 1 |
| 23 Apr 2015 | 7 -Layer Bar, 7-ounce(200 gram) flexible plastic wrap with adhesive-backed label. (71123) | Alpine Bistro & Bakery Company | Food | Class II | 1 |
| 23 Apr 2015 | Black & White Mini Cookies, Net Wt. 2 oz. (56 g), SKU 408785, UPC code 833282000495, Manufactured for: Starbucks Coffee Company, Seattle, WA --- The product comes in a clear film package, each containing two cookies. Each case contains 12 - 2 oz. packages (units). (71075) | Sweet Sam's Baking Company, LLC | Food | Class I | 1 |
| 23 Apr 2015 | Today's Harvest(TM) Field Peas w/Snaps, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209 | Greystone Foods LLC | Food | Class II | 3 |
| 22 Apr 2015 | CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector. | GE Healthcare | Device | Class II | 1 |
| 22 Apr 2015 | Purely Elizabeth Cranberry Cashew Ancient Grain Muesli, 10 ounces, packaged in plastic bag sealed into paper cartons, 6 packages per case, Manufactured by Natural Foodworks Group, LLC. Denver, CO (71060) | Natural Foodworks Group | Food | Class III | 1 |
| 21 Apr 2015 | Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of… | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 21 Apr 2015 | Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage. | Zimmer Surgical Inc | Device | Class III | 1 |
| 21 Apr 2015 | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 | Alvogen, Inc | Drug | Class II | 1 |
| 21 Apr 2015 | OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ, UPC 739885114174 --- The product is packaged in clear, plastic containers/tubs. | SM Fish Corp | Food | Class I | 3 |
| 20 Apr 2015 | 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided… | ICU Medical, Inc. | Device | Class II | 8 |
| 20 Apr 2015 | Blintzes with Cherry, Net Wt. 18oz (510g), 10 pieces. 18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Cherry with bar code 6 0723830021 8; 12 packs per case. | Royal Frozen Food | Food | Class I | 3 |
| 17 Apr 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 17 Apr 2015 | DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity. | DeRoyal Industries Inc | Device | Class II | 1 |
| 17 Apr 2015 | Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type… | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 17 Apr 2015 | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413 | Biosense Webster, Inc. | Device | Class II | 1 |
| 17 Apr 2015 | Walnuts Halves & Pieces in black foam trays with a green and gold label. Net Weight 16-oz 454.0 grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201 | Hines Nut Co | Food | Class I | 1 |
| 17 Apr 2015 | WHOLE FOODS MARKET Raw MACADAMIA NUTS NET WT 11OZ (312g) Distributed by Whole Foods Market Austin, TX 78703 | Whole Foods Market | Food | Class I | 1 |
| 16 Apr 2015 | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement | BioHorizons Implant Systems Inc | Device | Class II | 1 |
| 16 Apr 2015 | Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile (71016) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Apr 2015 | PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY | Wright Medical Technology, Inc. | Device | Class II | 4 |
| 16 Apr 2015 | The product comes in a 4-ounce clear plastic tear-strip enclosed container. The pine nuts are sold in store Produce Departments with a clear package front and tan-colored label on the back. The back label list Pine Nuts as the only ingredient. (71032) | Superior Nut & Candy Dist. Co. | Food | Class I | 1 |
| 15 Apr 2015 | Tastefully Simple, Blackberry Syrup, 12 FL oz ( 360 ml), Item 763905. Ingredients: Corn syrup, blackberries, cane sugar, lemon juice, natural flavor. Container consists of Glass, flask bottle with black boot seal over cap/neck of bottle. These multi-product items also include Blackberry Syrup: Rise ,n Shine… (71018) | Tastefully Simple, Inc | Food | Class II | 1 |
| 15 Apr 2015 | TRADER JOES A Dozen Sweet Bites Chocolate and Coffee Opera Cake, Raspberry Macaroon Cake, Caramel & Chocolate Cake, 9.16 oz UPC 00967679 or SKU 096767. (71017) | PROLAINAT | Food | Class II | 1 |
| 14 Apr 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 14 Apr 2015 | EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2)… | Philips Ultrasound, Inc. | Device | Class II | 2 |
| 14 Apr 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s). | bioMerieux, Inc. | Device | Class II | 1 |
| 14 Apr 2015 | The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT). | Integra LifeSciences Corp. | Device | Class II | 3 |
| 14 Apr 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to… | Nihon Kohden America Inc | Device | Class II | 1 |
| 14 Apr 2015 | Earth Coco Raw Coconut Water 100% Pure -320ml UPC 799632-585022 -500ml UPC 799632-585015 Distributed by: Earthcoco, Inc. 2651 Main Street Santa Monica CA 90405 www.earthcoco.com Product of Philippines **store frozen for maximum freshness** (70989) | Earthcoco | Food | Class II | 1 |
| 14 Apr 2015 | Border Grill Tortilla Soup Item # BOR-010, 3 x 8 lbs bags/case with Lot Codes Numbers between 140409 and 150311 Corn Maiden Foods, Inc. 24201 Frampton Av. Harbor City, CA 90710 LOT # Expiration Date Frozen: Expiration After Thaw: 7 days Border Grill Tortilla Soup INGREDIENTS: Sauce: Water, tomato filets (tomatoes,… (70998) | Corn Maiden Foods | Food | Class II | 1 |
| 13 Apr 2015 | COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells. | Beckman Coulter Inc. | Device | Class II | 1 |
| 13 Apr 2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 13 Apr 2015 | Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49 | Hospira Inc. | Drug | Class II | 2 |
| 13 Apr 2015 | Spinach; Packaging configurations per case: One 4 pound bag; Four 2.5 bags; Four 1 pound bags; | Taylor Fresh Foods Inc | Food | Class I | 1 |
| 13 Apr 2015 | Terra Spice Company Jalapeno Cheddar (dry spice mix). Sold in 0.5, 1, 3, or 5 qt. jars, 6x10 stand up pouches, and bulk up to 50 lbs | Greenies LLC d.b.a. Terra Spice Company | Food | Class II | 6 |
| 10 Apr 2015 | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number. | Pega Medical Inc. | Device | Class II | 1 |
| 10 Apr 2015 | EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1)… | Philips Ultrasound, Inc. | Device | Class II | 2 |
| 10 Apr 2015 | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only | Alphatec Spine, Inc. | Device | Class II | 1 |
| 10 Apr 2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30 | Medtech Products, Inc. | Drug | Class III | 1 |
| 10 Apr 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 | Oasis Medical, Inc. | Drug | Class III | 1 |
| 10 Apr 2015 | BRIDGE CITY Baking gluten free Marionberry Crumble Pie. This product is frozen ready to bake. Net Wt 24oz UPC 0 91037 54454 4 | Bridge City Baking LLC | Food | Class II | 3 |
| 9 Apr 2015 | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 9 Apr 2015 | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 9 Apr 2015 | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. | Synthes, Inc. | Device | Class II | 1 |
| 9 Apr 2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of… | Spinal Elements, Inc | Device | Class III | 1 |
| 9 Apr 2015 | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction. | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 9 Apr 2015 | Macadamia Nuts in 8 oz and 16 oz clear plastic bags. | Texas Pecan Co | Food | Class I | 4 |
| 9 Apr 2015 | Bountiful Harvest Chopped Spinach, KEEP FROZEN, Net Wt. 3 LBS. (1.36kg), Case with 12; Chopped Spinach (Cheney Brothers) 3 pounds, 12 per case; Essential Everyday Chopped Spinach Net Wt. 10 oz. (283g), 24 per case; Essential Everyday Chopped Spinach Net wt. 16 oz. (1 LB) 454g, 12 per case; Fareway Grade A Fancy… (71068) | Magic Valley Fresh Frozen, Inc | Food | Class III | 1 |
| 8 Apr 2015 | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. | Baxter Corporation Englewood | Device | Class II | 1 |
| 8 Apr 2015 | AMERICA'S BEST (JEERA) CUMIN POWDER, 1) NET WT. 7 OZ. (200 GMS), 2) 14 OZ. (400 GMS), and 3) 28 OZ. Packed by: Patel Grocery 5303 4th Avenue Brooklyn, NY 11220 Tel: 718-748-6369 (70671) | Patel Grocery Corp | Food | Class I | 1 |
| 7 Apr 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Apotex Inc. | Drug | Class III | 3 |
| 7 Apr 2015 | Central Market Teriyaki Salmon Jerky, 3 oz. per plastic retail pouch. The front label is correctly identified as Teriyaki Salmon Jerky, but the back side was mis-labeled as Smoked Salmon Jerky with the UPC 0 41220 34270 9. (70935) | World Wide Gourmet Foods, Inc. dba Alaska Smokehouse | Food | Class I | 1 |
| 7 Apr 2015 | Sabra Classic Hummus 10 oz UPC 040822011143 / 300067, Sabra Dipping Co. LLC, White Plains, NY | Sabra Dipping Company, LLC | Food | Class I | 5 |
| 6 Apr 2015 | Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal… (70836) | GA Industries | Device | Class II | 1 |
| 6 Apr 2015 | Deer Cumin Powder Packed for Best Foods Inc., Edison, NJ 08817 a) 7 oz. UPC 71476027497 b) 14 oz..UPC 714760027503 Not all packages are marked with a UPC barcode 12 packages to a case | Best Foods NJ, Inc. | Food | Class I | 1 |
| 3 Apr 2015 | Peterson's Macadamias Net Wt 16 oz. (454g) King Nut Companies Solon, OH 44139 www.petersonsnuts.com INGREDIENTS: Macadamia Nuts, Peanut and/or Canola Oil, Salt. 0 74870 10365 9 | Kanan Enterprises, Inc. | Food | Class I | 1 |
| 2 Apr 2015 | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection. (71127) | MELA Sciences, Inc. | Device | Class II | 1 |
| 2 Apr 2015 | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. | Zimmer, Inc. | Device | Class II | 1 |
| 2 Apr 2015 | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Apr 2015 | Cleveland Crops Chili Cheezy Kale Chips Made with 100% Dehydrated Raw Kale, Raw, Gluten Free, Vegan, No Preservatives FRESH PRODUCE NO SUGAR ADDED CUYAHOGA COUNTY Board of Developmental Disabilities INGREDIENTS Raw Dehydrated Kale, Tomatoes, Lemon Juice, Chili Powder, Garlic Powder, Onion Powder, Sea Salt. NT WT 2 OZ… (70973) | Cleveland Crops Food Innovation Center | Food | Class I | 1 |
| 2 Apr 2015 | Smith's Bakery brand fresh carrot cake, net weight 5 ounces 7 50903 91714 0, 22 ounce 1.38 pound 1/8 Sheet) 7 70118 22460 4, 82 ounce (5.13 pound 1/4 sheet) 0 41573 07058 8 Smith's Food & Drug Stores (71007) | Smith's Food And Drug, Inc | Food | Class I | 1 |
| 2 Apr 2015 | KT's Energy Bars, net weight per bar is 2.9 oz (82.21 g). | Taylor Catering,LLC | Food | Class II | 4 |
| 2 Apr 2015 | Whole Foods Market Health Starts Here Rye Bread (formerly 100% Rye) 16 oz. PLU# 41844 | Whole Food Market | Food | Class II | 1 |
| 1 Apr 2015 | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Teleflex Medical | Device | Class II | 1 |
| 1 Apr 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected… | Dako North America Inc. | Device | Class II | 1 |
| 31 Mar 2015 | C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414 (70921) | Cody Laboratories, Inc. | Drug | Class II | 1 |
| 31 Mar 2015 | Organic Hummus HOPE Kale Pesto Spread Good Things, Net Wr 8 oz (227g), Best By date of 05/04/15. (70892) | Hope Foods, LLC dba Hope HUmmus | Food | Class I | 1 |
| 30 Mar 2015 | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space. | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 30 Mar 2015 | Navajo Pride Bleached All Purpose Flour in 50 lb, 25 lb, and 5 lb Cloth Bags by Navajo Agricultural Products Industry. (70880) | Navajo Agricultural Products Industry dba Flour Milling | Food | Class I | 1 |
| 29 Mar 2015 | Plain Bagels; Sell By: (up to and including) 04/02/15; UPC: 67785 30499; Net Wt 22oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels. | Giant Eagle, Inc. | Food | Class II | 9 |
| 29 Mar 2015 | Heat & Serve Fried Fish Sell By: (up to and including) 4/02/15 PLU: 37156 Contains Fish (Pangasus), Soy, Wheat Giant Eagle Distributed by: Giant Eagle, inc., Pittsburgh, PA 15238 | Giant Eagle, Inc. | Food | Class I | 3 |
| 27 Mar 2015 | CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal… | B. Braun Medical, Inc. | Device | Class II | 1 |
| 27 Mar 2015 | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. | Biomerieux Inc | Device | Class II | 3 |
| 27 Mar 2015 | AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. (70888) | Amtryke LLC | Device | Class II | 1 |
| 27 Mar 2015 | Deer Raisin Golden 7 oz., marked and unmarked packages Packed for Best Foods Inc. Edison, NJ 08817 Some have UPC 714760029255. packaged in clear plastic packages. | Best Foods NJ, Inc. | Food | Class I | 1 |
| 26 Mar 2015 | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 12 |
| 26 Mar 2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. | Handicare USA, Inc. | Device | Class II | 1 |
| 26 Mar 2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 26 Mar 2015 | Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case (70850) | Mead Johnson Nutrition | Food | Class II | 1 |
| 26 Mar 2015 | Style 2 South Africa Macadamia Nuts, (70848) | Red River Foods Inc | Food | Class I | 1 |
| 26 Mar 2015 | CHEESE DANISH 2 COUNT; PLU: 59779; NET WT 6.0 oz.; CONTAINS: WHEAT, SOY, MILK; In clear plastic clamshell | Giant Eagle, Inc. | Food | Class I | 4 |
| 25 Mar 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The… | Stryker Instruments Div. of Stryker Corporation | Device | Class III | 1 |
| 25 Mar 2015 | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Lumenis Limited | Device | Class II | 1 |
| 25 Mar 2015 | Giant Eagle Buffalo Boneless Chicken Wings; PLU#: 27320; Sell By: (up to and including) 03/30/2015; Contains: Soy, Wheat; Keep Refrigerated; Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 Packed in rigid plastic Clear/Black container Prepared and packaged at retail store. FINISHED PRODUCT IS NOT A USDA… | Giant Eagle, Inc. | Food | Class II | 6 |
| 24 Mar 2015 | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 23 Mar 2015 | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 23 Mar 2015 | Simply Balanced Organic Chopped Spinach NET WT 10 OZ (283g) steam-in-bag Needs to be fully cooked Keep frozen (70819) | Superior Foods | Food | Class II | 1 |
| 21 Mar 2015 | Giant Eagle Store cut Fontal Cheese wrapped in plastic wrap Belgium Imported Fontal - CD; Sell By: (up to and including) 04/23/2015 PLU: 16124 Giant Eagle Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 | Giant Eagle, Inc. | Food | Class I | 1 |
| 20 Mar 2015 | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery. | CooperSurgical, Inc. | Device | Class II | 1 |
| 20 Mar 2015 | Nature's Eats Natural Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00912-7; Central Market Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00820-5 | Texas Star Nut and Food Co., Inc. | Food | Class I | 2 |
| 20 Mar 2015 | La Terra Fina Organic Thick & Creamy Spinach Dip and Spread; Made with Greek Yogurt. 24 oz. plastic tub (1 lb. 8 oz,) 680 g: Keep refrigerated UPC 640410513730. Manufactured by" La Terra Fina, Union City, CA 94587 | La Terra Fina, Inc. | Food | Class I | 3 |
| 20 Mar 2015 | Wawa brand Kale and Quinoa Salad, 7.5-oz. plastic container, UPC Code: 726191066402 | Taylor Farms Florida, Inc. | Food | Class I | 1 |
| 20 Mar 2015 | Walnuts: America Choice, 12 oz. Plastic Pouch, UPC: 75480779049; Aurora , 6.5 oz. Plastic Cup, UPC: 65585200097; Aurora, 14.0 oz. Plastic Tub, UPC: 65585200070; Aurora, Bulk, NO UPC; Aurora, 4.0 oz. Plastic Pouch, UPC: 65585200490; Aurora, 12.0 oz. Plastic Pouch, UPC: 65585200316; Belmont Market, 6.5 oz. Plastic Cup,… | Aurora Products, Inc. | Food | Class I | 12 |
| 20 Mar 2015 | Essential Everyday Chocolate Covered Raisins, Net Wt. 32 oz. in Clear plastic tub with black lid. UPC Code 41303-05311 | Supervalu | Food | Class I | 2 |
| 20 Mar 2015 | Cadia Organic Cut Spinach, 16 oz. (454 g) frozen packages, UPC 15369 01165 | Twin City Foods Inc | Food | Class II | 4 |
| 19 Mar 2015 | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic… (70906) | Incisive Surgical Inc | Device | Class II | 1 |
| 18 Mar 2015 | Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder. | Zimmer Gmbh | Device | Class II | 1 |
| 17 Mar 2015 | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods. | Biocare Medical, LLC | Device | Class II | 1 |
| 17 Mar 2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Akorn, Inc. | Drug | Class II | 3 |
| 17 Mar 2015 | Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Fallon Wellness Pharmacy, L.L.C. | Drug | Class II | 10 |
| 17 Mar 2015 | Trader Joe's Nuts Raw California Walnut Pieces NET WT. 16oz. (1 LB) 454g UPC 00373685 Trader Joe's Nuts Raw California Walnut Halves & Pieces NET WT. 16 OZ (1 LB) 454g UPC 00943338 Trader Joe's Nuts Raw California Walnut Baking Pieces NET WT. 16 OZ (1 LB) 454g UPC 00519342 Trader Joe's Nuts Raw California Premium… | Trader Joes Company | Food | Class I | 1 |
| 17 Mar 2015 | All varieties and packaging configurations of iced cut out cookies, labeled as Decorated Cut Out Cookie and Cut Out Cookies, 1oz and 2oz sold individually behind the bakery department service counter, and also pre-packaged in 2 counts (5oz), 10 counts (15oz), inside clear plastic containers, "processed on shared… | Giant Eagle, Inc. | Food | Class I | 3 |
| 17 Mar 2015 | Wegmans Organic Food You Feel Good About Walnut Halves & Pieces, NET WT. 6 oz (170 g), UPC 077890358009. Distributed by Wegmans Food Markets, Inc. Rochester, NY 14609. Product is packed in a clear tub. Each case has contains 12 units (tubs). (70760) | First Source Llc Buffalo | Food | Class I | 1 |
| 16 Mar 2015 | Cheese Ravioli, RV 301, 96 Ct. Deep Frozen, MF# RV301 and Frozen Cheese Ravioli (Jumbo) Mama Ricottas, MF# RV366, 192 ct., Manufactured by: Drakes Fresh Pasta Company, 636 Southwest Street, High Point NC 27260 (sold in bulk to food service facilities only). (70795) | Drake's Fresh Pasta Company, Inc. | Food | Class II | 1 |
| 15 Mar 2015 | Spinach & Goat Cheese Pizza (Focaccia) Mackenzie Limited Spinach & Goat Cheese Focaccia 18 PCS #SGC18 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. | Gourmet Kitchen, Inc. | Food | Class II | 6 |
| 13 Mar 2015 | Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 13 Mar 2015 | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure. | Vital Signs Colorado Inc. | Device | Class II | 2 |
| 13 Mar 2015 | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media… | Bard Access Systems | Device | Class II | 1 |
| 12 Mar 2015 | Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA | Wockhardt Usa Inc. | Drug | Class II | 1 |
| 11 Mar 2015 | Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 11 Mar 2015 | Sunrise Foods Saffron (Kasvbha), Net Wt. 1 oz. (29g), Product of the Philippines, Manufactured by: Sunrise Native Foods Product, GMC May-Tamo Bagungbayan Teresa, Rizal, Philippines | Phil-Am Trading, Inc. | Food | Class II | 1 |
| 10 Mar 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 10 Mar 2015 | ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. (70661) | Ultra ZX Supplements | Drug | Class I | 1 |
| 9 Mar 2015 | Black Bean Burger 4.5 oz 40 pieces Net Wt. 11.25 lbs. (5.10 kg)Manufactured by: Cuisine Innovations, LLC Lakewood, NJ 08701 USA UPC 00030499640296 For Institutional Use Only | Cuisine Innovations LLC dba Bon Appetizers, LLC | Food | Class II | 4 |
| 6 Mar 2015 | ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. | Brainlab AG | Device | Class II | 1 |
| 6 Mar 2015 | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC. | Cyberonics, Inc | Device | Class II | 1 |
| 6 Mar 2015 | MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1. | Hospira Inc. | Drug | Class I | 1 |
| 5 Mar 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25. | Hospira Inc. | Drug | Class I | 1 |
| 27 Feb 2015 | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 26 Feb 2015 | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures. | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 26 Feb 2015 | Gouveia Crushed Red Pepper Imported from the Azores Pimenta Moida, Packed in glass jar, Net Wt 16 oz (70718) | Gouveia & Sons Imports | Food | Class I | 1 |
| 24 Feb 2015 | Clear Choice Diet Orange Mango | Cott Beverages Inc. | Food | Class II | 11 |
| 20 Feb 2015 | 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 4 |
| 19 Feb 2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit. (70662) | Arc Medical Inc | Device | Class III | 1 |
| 19 Feb 2015 | AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities. | Steris Corporation | Device | Class II | 1 |
| 19 Feb 2015 | Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required. | Steris Corporation | Device | Class II | 1 |
| 17 Feb 2015 | EOS, Digital radiography system used in general radiographic examinations. (70732) | Eos Imaging Inc | Device | Class II | 1 |
| 17 Feb 2015 | Jose' Madrid SALSA BLACK BEAN CORN POBLANO SALSA NET WT 13 OZ (369 G) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934***0 93662 45287 4 | Michael Zakany LLC | Food | Class II | 1 |
| 12 Feb 2015 | 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Health Innovations Pharmacy, Inc | Drug | Class II | 65 |
| 9 Feb 2015 | Philips Healthcare DigitalDiagnost System X-Ray | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 7 Feb 2015 | Guacamole Dip Net Wt. 8 OZ. (.5LB) Distributed By: Whole Foods Market UPC/PLU: 0-36406-30279-0; WFM Dip Guacamole PPK UPC/PLU: 3640630278; Guacamole Bulk CC UPC/PLU: 27013500000 in plastic container | Whole Foods Market | Food | Class I | 39 |
| 4 Feb 2015 | FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 4 Feb 2015 | Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 4 Feb 2015 | Ground Cumin, Bulk Package Size: a) 50 lb. paper carton b) 16 oz. jar/ 8 plastic jars per case | International Foodsource, LLC | Food | Class I | 1 |
| 3 Feb 2015 | Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 29 Jan 2015 | Aleia's Parmesan Croutons, Gluten Free, NET WT 8 oz (226.8g). UPC Code: 8 55930 00162 3, Product is packaged in a brown cardboard box with white text. | Aleias Gluten Free Foods LLC | Food | Class III | 2 |
| 29 Jan 2015 | Pride of Szeged Hungarian Exquisite 100 % Sweet Delicacy Paprika, Net Wt. 5 oz., 142g, UPC 0 78006 00010 2 | Spiceco, Inc. | Food | Class I | 16 |
| 28 Jan 2015 | 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products,… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 26 Jan 2015 | Sazon Coriander & Annatto | Sazon, Inc. | Food | Class II | 5 |
| 25 Jan 2015 | EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4. | Individual firm, name withheld | Drug | Class I | 5 |
| 17 Jan 2015 | RADER FARMS¿ Fresh Start Smoothie Blend, Costco item no. 911885, Net wt. 48 (oz) 3 lbs. The UPC is 8 84038 85148 9. | Inventure Foods | Food | Class II | 3 |
| 15 Jan 2015 | ViewRay System, Radiation Therapy System | Viewray Incorporated | Device | Class II | 1 |
| 9 Jan 2015 | Krystyna Bakery Polish Style Cheese Cake, Weight 18 oz., UPC 789438000096 (70939) | Krystyna Bakery | Food | Class II | 1 |
| 8 Jan 2015 | JCB Flavors, LLC, Product Code 10064010, Chili Powder, 10 lb bulk. | JCB Flavors, LLC | Food | Class I | 42 |
| 6 Jan 2015 | Woodsmen's American Seasoning Net Weight 13 oz; and 3.2 oz Distributed by: WOODSMEN'S AMERICAN SEASONING, LINESVILLE, PA 16424 UPC: 32489; 35765 LOT #: 212281 | Con Yeager Spice Co | Food | Class I | 30 |
| 2 Jan 2015 | Goya Congri Cuban-Style Black Beans & Rice (Moros & Cristianos), Net Wt./Peso Neto, 8 oz.(227g), Distributor: Goya Foods Inc., Secaucus, NJ 07096 USA, UPC 041331025959 | Goya Foods | Food | Class II | 4 |
| 23 Dec 2014 | FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . | Therasage, LLC. | Device | Class II | 3 |
| 22 Dec 2014 | Vital Labs Halo-V, 80 Capsules, Dietary Supplement, Supplement Facts: Serving Size: 1 Capsule, Servings per Container: 80, Amount Per Serving, 4-Chloro-17 a-Methyl-Android-1,4-Dieme-3-17b-Diol 25mg Other ingredients: Gelatin, Magnesium Stearate, Rice Flour Vital Labs, 7 98304 19367 1, (775) 298-LABS, Packaged in… (70833) | A2Z Industries, LLC | Food | Class II | 1 |
| 19 Dec 2014 | GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx | GE Healthcare | Device | Class II | 3 |
| 12 Dec 2014 | M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Anabolic Science Labs, LLC | Drug | Class I | 7 |
| 28 Nov 2014 | Cambridge House Balmoral Thinly Sliced Exceptional Ready to Enjoy Smoked Salmon Keep Refrigerated at 38 or below Ingredients Atlantic Salmon, Salt, Sugar, and Oakwood Smoke Produced By: The Santa Barbara Smokehouse 312 N. Nopal Santa Barbara, CA 93103 www.sbsmokehouse.com Coastal Harbor by The Santa Barbara… | The Santa Barbara Smokehouse, Inc. | Food | Class I | 1 |
| 3 Nov 2014 | Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA | REFA Enterprises, LLC | Drug | Class I | 2 |
| 24 Oct 2014 | GE Discovery MR950 MRI system | GE Healthcare | Device | Class II | 1 |
| 20 Oct 2014 | La Fe Green Hot Sauce, 5.6 Fl. Oz. - 165 mL, Imported by: G & T Foods, Inc., Moonachie, N.J. 07074, Distributed by: LA FE Foods, Product of Columbia, UPC 023545211052 (70218) | Le Fe Foods, Inc. | Food | Class II | 1 |
| 4 Sep 2014 | IBERIA Yellow Rice Spanish Style Enriched Parboiled Rice (70349) | Iberia Foods Corp. | Food | Class II | 1 |
| 15 Aug 2014 | Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular… | Stryker Howmedica Osteonics Corp. | Device | Class II | 3 |
| 8 Aug 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan… | Beckman Coulter, Inc. | Device | Class II | 7 |
| 24 Jul 2014 | Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216 (70703) | Physician Preferred Medical, LLC | Drug | Class I | 1 |
| 14 May 2014 | MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 17 Apr 2014 | The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 8 Apr 2014 | MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 11 Jul 2012 | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 11 May 2012 | ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |