| 14 Aug 2017 | Rainbow Carrot and Quinoa Salad, ready to eat product, packaged in one pint clear plastic deli containers, sold at random weight. UPC 252383-001604. | NEW SEASONS MARKET | Food | Class II | 1 |
| 11 Aug 2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc.… | PD-Rx Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 10 Aug 2017 | Zydot Ultimate Blend Detox Drink Natural Tropical Ice Flavor 32 fl. oz. (946 ml) and 16 fl. oz. (473 ml) packaged in clear plastic bottles (77900) | Zydot Unlimited, Inc | Food | Class II | 1 |
| 10 Aug 2017 | IQF Green Beans, Keep Frozen. 11 varieties, packaged under the following brands and sizes: 1) Bountiful Harvest French Style Green Beans, 1 - 10lb carton/case; 2) GFS French Style Green Beans, 12 32oz (2lb) poly bags per case; 3) Bountiful Harvest Cut Green Beans, 1 20lb carton/case; 4) West Creek Cut Green… | Lakeside Foods, Inc | Food | Class II | 1 |
| 9 Aug 2017 | Royal Mills, Iced Cappuccino, Premium Coffee. 11.0 FL. OZ. (325 ml) 2-piece aluminum can; Made in Hawaii. UPC: 0 73366 12755 (77942) | Ito En (USA) Inc. | Food | Class II | 1 |
| 9 Aug 2017 | The Best Bar Ever, Peanut Butter Crunch, 1.41 oz., 40 gm. (77953) | The Best Bar Ever Inc. | Food | Class II | 1 |
| 8 Aug 2017 | Wegmans Apple Crostata, Large, Net Wt. 23 oz. and 6 oz. (In-Store Bakery) | Wegmans Food Markets, Inc. | Food | Class II | 4 |
| 7 Aug 2017 | Taylor Farms Creamy Homestyle Coleslaw Kit, dressing included. Green Cabbage, Carrots, Red Cabbage and Creamy coleslaw dressing. Triple washed and ready to enjoy. Salad Net. WT. 11.5 oz. , Dressing NET WT. 3. FL. oz. UPC: 030223040637 | Taylor Farms Retail, Inc. | Food | Class I | 1 |
| 4 Aug 2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01 | Amgen, Inc. | Drug | Class II | 1 |
| 3 Aug 2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940 | KVK-Tech, Inc. | Drug | Class III | 1 |
| 3 Aug 2017 | Broccoli Florets packaged with the following [Product Brand, amount per case / pounds per package, item code]: 1) Imperial Fresh, 1/5#, 6712509; 2) Imperial Fresh, 1/3#, 9731258; 3) Imperial Fresh, 1/5#, 1515360; 4) SYSCO Imperial, 4/3#, 6540843; 5) Imperial Fresh, 1/5#, 6709356; 6) SYSCO Imperial, 4/3#, 6540843 | Go Fresh | Food | Class II | 3 |
| 3 Aug 2017 | SKU 081223, Trader Joes Asian Stir Fry, 12/18 oz packages, UPC 812238 Ingredients Statement: Green Pepper, Broccoli, Red Pepper, Snap Peas, Snow Peas Pods, White Onion, Red Onion, Mushrooms, Carrots, Bok Choy, Bamboo Shoot, Baby Corn, and Water Chestnut. | Mary's Harvest Fresh Foods, Inc. | Food | Class II | 18 |
| 2 Aug 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85 | The Harvard Drug Group | Drug | Class II | 5 |
| 2 Aug 2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 2 Aug 2017 | Gold Coast Packing Broccoli Florets; packed in the following configurations: 12 x 2 lb - Product code 508215 - Costco Canada; 1 x 40 lb.- Product code 504405 4 x 3 lb. - Product Codes 503401; 503409 4 x 3 lb. pizza cut -Product Code 503405 4 x 3 lb. - Mini florets - Product code 503412 2 x 5 lb. - Asian cut -Product… (77879) | Fresh Venture Foods, LLC | Food | Class II | 1 |
| 1 Aug 2017 | Fairway brand Cookies Blondie, 10 oz. Item Code 268492 XXXXXX or 263413 XXXXXX. (77871) | Fairway Group Holdings Corp | Food | Class II | 1 |
| 31 Jul 2017 | J.J. LAWSON BELGIUM CHOCOLATE ICE CREAM, 3 gallon round container | Bliss Microcreamery, Inc. | Food | Class I | 2 |
| 31 Jul 2017 | Friendly Farms Key Lime Crunch Tilts Greek Lowfat Yogurt, 5.3oz plastic cup, Best by date: AUG/26/2017 04-161 and SEP/22/2017 04-161, UPC for this product is 041498239091, Keep refrigerated (77875) | Commonwealth Dairy, Llc | Food | Class I | 1 |
| 28 Jul 2017 | Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case | Cardinal Health 200, LLC | Device | Class II | 1 |
| 28 Jul 2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 28 Jul 2017 | Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns, 11.3 Ounces, in plastic bag (77838) | SIlver HIlls Bakery | Food | Class I | 1 |
| 26 Jul 2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01 | HOSPIRA INC, LAKE FOREST | Drug | Class II | 3 |
| 26 Jul 2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09 | ICU Medical Inc | Drug | Class II | 1 |
| 26 Jul 2017 | Acidophilus-Plus, No. 102, 90 Capsules, Dietary Supplement, | NatureAll-STF Holding, LLC | Food | Class I | 8 |
| 25 Jul 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 24 Jul 2017 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 22 Jul 2017 | Hy-Vee, Cheese Pizza, 12'' Traditional Crust, UPC 288900 908996, Net Wt. 26 oz (1 lb 10 oz) 1.62 lb (737 g), West Des Moines, IA | D & D Foods, Inc. | Food | Class II | 4 |
| 21 Jul 2017 | Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive label with White, black red and green print; bottle has a heat-shrink band. UPC code 8 40851 10054 0. (77806) | Professional Complementary Health Formulas, LLC | Food | Class II | 1 |
| 21 Jul 2017 | Viva ben Femenine Supplement, Dietary Supplement 30 Softgels | Duy Drugs Inc. | Food | Class II | 2 |
| 21 Jul 2017 | BUSH'S BEST¿ Brown Sugar Hickory SWEET HICKORY SAUCE WITH BROWN SUGAR & SPICES BAKED BEANS 28 OZ (1 LB 12 OZ) 794 g BUSH BROTHERS & COMPANY P. O. Box 52330, Dept, C KNOXVILLE, TN 37950-2330 UPC 0 39400 01977 0 | Bush Brothers & Co | Food | Class II | 3 |
| 21 Jul 2017 | The Comfy Cow Banana Pudding Y'all Ice Cream 1 pint | Koogee-Queen Anne, LLC | Food | Class II | 9 |
| 20 Jul 2017 | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30 | Hetero USA Inc | Drug | Class II | 1 |
| 20 Jul 2017 | "Because They Work" GRANDMA'S HERBS CHOLESTEROL SUPPORT, Dietary Supplement, 100 Capsules 480 mg. Packaging: PET plastic bottles, UPC# 714938 00046 (77941) | Individual firm, name withheld | Food | Class III | 1 |
| 19 Jul 2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12 | AVKARE Inc. | Drug | Class III | 1 |
| 19 Jul 2017 | IQF White Rice ES CA, Cardboard Tote, product #4621686100. | General Mills, Inc | Food | Class I | 1 |
| 19 Jul 2017 | Pumpkin Seeds, Blackened Seasoned 10 LB (77819) | TRULY GOOD FOODS | Food | Class I | 1 |
| 17 Jul 2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate… | Vi-Jon, Inc. | Drug | Class II | 1 |
| 17 Jul 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005. | Linde Eckstein Gmbh + Co KG | Drug | Class III | 14 |
| 17 Jul 2017 | NatureBox Sticks 'n Stones; roasted nuts with sesame sticks. Packed in 5 oz. pouch and 5 lb. corporate bag | NatureBox, Inc. | Food | Class II | 1 |
| 14 Jul 2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58. | SCA Pharmaceuticals | Drug | Class II | 6 |
| 14 Jul 2017 | BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40 | SCA Pharmaceuticals | Drug | Class II | 30 |
| 14 Jul 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12 | Cantrell Drug Company | Drug | Class II | 18 |
| 14 Jul 2017 | WOODSTOCK ORGANIC MATCHA VANILLA OATS, 1.8 oz (50g) cup UPC: 0-42563-01786-6 (77767) | Garden Of Light Inc. | Food | Class I | 1 |
| 14 Jul 2017 | Coconut Beverage, So Delicious brand, 1.89 liter carton. | The Idaho Foodbank | Food | Class II | 4 |
| 13 Jul 2017 | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The… | In2Bones, SAS | Device | Class II | 1 |
| 13 Jul 2017 | Whole Foods Market Thai Shrimp Salad, Net Wt. 14 oz.. packaged in a clear clamshell container (refrigerated) (77755) | Cafe Spice GCT DBA Zaika Flavors of India Inc. | Food | Class II | 1 |
| 12 Jul 2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025 (77757) | Individual firm, name withheld | Drug | Class II | 1 |
| 12 Jul 2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701. | Akorn Inc | Drug | Class III | 3 |
| 12 Jul 2017 | STUTZMAN FARMS Organic Spelt Berries 25 lb 11.4 kg 6197 | Stutzman Farms | Food | Class II | 2 |
| 11 Jul 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence | Olympus Scientific Solutions Americas | Device | Class II | 1 |
| 11 Jul 2017 | Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. (77734) | Individual firm, name withheld | Drug | Class III | 1 |
| 10 Jul 2017 | Silver Star Tex-Mex Style Chipotle Queso Medium Dip Net Wt 16 OZ (1 Lb) packaged in a glass jar (77766) | Texas Legend Foods | Food | Class I | 1 |
| 8 Jul 2017 | Whole Foods Market PB & J Parfait Made With Greek Yogurt; Net Wt 8 OZ.; (77730) | Sunneen Health Foods, LLC | Food | Class I | 1 |
| 6 Jul 2017 | BioHealth Pasture Fed Precision Blend Time Release Protein: Cookies and Cream Flavor; Sold in 2 lb.(960G) UPC 6 42014 59446 7 and 4 lb. (1,920G) UPC 6 42014 59447 4 white plastic containers. (77740) | Innovative Nutrition Technologies | Food | Class II | 1 |
| 6 Jul 2017 | ISABEL, Octopus in vegetable oil, Pulpo en aceite vegetal, Net wt - Peso Neto 4 oz(115g) | ISABEL NORTH AMERICA, INC. | Food | Class II | 3 |
| 6 Jul 2017 | Fudge Brownie, Net Wt. 9 oz. (0.6 lb.) (255g), with the following brands: 1. Cashwise Gluten Free Bakery, 2. Coborn's Gluten Free Bakery. | Coborn's, Inc | Food | Class II | 1 |
| 5 Jul 2017 | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. | Baxter Healthcare Corporation | Device | Class II | 2 |
| 5 Jul 2017 | ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0 | Individual firm, name withheld | Drug | Class I | 2 |
| 5 Jul 2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59. | Precision Dose Inc. | Drug | Class II | 1 |
| 5 Jul 2017 | Anarkali Peshawari Naan Bread Frozen 15oz. retail plastic pouch 24 retail units per wholesale case (77685) | Raja Foods, L.L.C. | Food | Class I | 1 |
| 5 Jul 2017 | Clif Builders Variety Pack Chocolate Peanut Butter and Chocolate Mint 18-count | Clif Bar & Company | Food | Class I | 5 |
| 3 Jul 2017 | Steamers in 5 Clams in Butter & Garlic Sauce, Goose Point brand. Product is packaged in a plastic tray with heat sealed plastic film and packed in fiber pre-printed retail box. Net wt. 1 lb (454 gram). UPC 0 92206 16101 2. The label is read in parts "****100% NATURAL INGREDIENTS: Clams, Butter (Cream, Salt), Garlic,… (77677) | Nisbet Oyster Co Inc | Food | Class II | 1 |
| 3 Jul 2017 | HY-TOP Rice MIX CHICKEN FLAVORED RICE & VERMICELLI WITH SEASONINGS NET WT 6.9 OZ (196g) | Trinidad Benham Corp | Food | Class II | 1 |
| 30 Jun 2017 | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein. | CareFusion 303, Inc. | Device | Class II | 1 |
| 30 Jun 2017 | STOCKERT Heater-Cooler System 3T, 230 V | Sorin Group USA, Inc. | Device | Class II | 6 |
| 30 Jun 2017 | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery | Alcon Research, Ltd. | Device | Class II | 2 |
| 30 Jun 2017 | Publix Greenwise Cashew Butter, NET WT 16 oz (1 lb) 454g, Distributed by Publix Super Markets, Inc, Lakeland, FL 33802 (77769) | Publix Supermarkets, Inc. (Deli Kitchen) | Food | Class II | 1 |
| 29 Jun 2017 | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or… | Boston Scientific Corporation | Device | Class II | 3 |
| 29 Jun 2017 | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA | Sorin Group USA, Inc. | Device | Class II | 16 |
| 29 Jun 2017 | Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM)… | Medtronic Navigation, Inc. | Device | Class II | 8 |
| 28 Jun 2017 | GE Inspection Technologies Blade|line Industrial Cabinet X-ray system | GE Inspection Technologies, LP | Device | Class II | 1 |
| 28 Jun 2017 | Kettle Brand Krinkle Cut Potato Chips Spicy Queso, 8.5 oz., Distributed by: Kettle Foods, Inc., Salem, OR 97301, UPC: 84114 90042 | Kettle Foods, Inc. | Food | Class II | 1 |
| 28 Jun 2017 | Dierbergs Kitchen, Grilled Chicken Caesar Wrap, NET WT. 10 oz, UPC 0 233983 804994 | Dierbergs Markets, Inc Corporate Office | Food | Class I | 4 |
| 27 Jun 2017 | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument. | Hologic, Inc | Device | Class II | 1 |
| 27 Jun 2017 | Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from… | Cardinal Health 200, LLC | Device | Class II | 2 |
| 27 Jun 2017 | Black Beans Bonanza Tamales with black beans. No Dairy: (77779) | Individual firm, name withheld | Food | Class I | 1 |
| 27 Jun 2017 | PB Crave, Coconut Milk Chocolate Peanut Butter Spread, NET WT 16 OZ (1 LB) -454 g. Plastic jars, 6 per case. (77688) | Peanut Butter holdings, LLC | Food | Class III | 1 |
| 26 Jun 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001 | Individual firm, name withheld | Device | Class II | 4 |
| 26 Jun 2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50 | VistaPharm, Inc. | Drug | Class II | 2 |
| 26 Jun 2017 | Plain Ol' Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO. | Shatto Milk Co | Food | Class II | 8 |
| 23 Jun 2017 | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is… (77653) | Xintec Corp | Device | Class II | 1 |
| 23 Jun 2017 | Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle | Exactech, Inc. | Device | Class II | 1 |
| 23 Jun 2017 | Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. | International Medsurg Connection, Inc. | Device | Class II | 59 |
| 22 Jun 2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery | Medtronic Perfusion Systems | Device | Class II | 5 |
| 22 Jun 2017 | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in… | Quidel Corporation | Device | Class II | 1 |
| 22 Jun 2017 | MCCAIN ONION RING BATTERED PORTION PERFECT ¿ 60X4 oz (77612) | McCain Foods Canada, Inc. | Food | Class II | 1 |
| 22 Jun 2017 | SAMI'S BAKERY, Peanut Butter Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL. | Sami's Pita Bakery, Inc. | Food | Class II | 5 |
| 21 Jun 2017 | PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. | Valorem Surgical LLC | Device | Class II | 144 |
| 20 Jun 2017 | Medium Coated Jo-Jo Wedges / 00040 (5lb bags) | Penobscot McCrum LLC | Food | Class II | 10 |
| 19 Jun 2017 | iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. | Elekta, Inc. | Device | Class II | 1 |
| 19 Jun 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15 | Apace KY LLC | Drug | Class II | 2 |
| 16 Jun 2017 | CS 100i Intra-Aortic Balloon Pump | Maquet Datascope Corp - Cardiac Assist Division | Device | Class I | 3 |
| 16 Jun 2017 | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50 (77576) | Time-Cap Laboratories, Inc. | Drug | Class II | 1 |
| 16 Jun 2017 | Planetary Herbals Ginseng Classic; Classic Chinese Energizer 710 mg; 60 and 120 UPC 0 21078 10215 1 tablet bottles; 60 count - UPC 0 21078 10214 4; Product code PF0214 120 count - UPC 0 21078 10215; Product code PR0215. | Threshold Enterprises Ltd | Food | Class II | 1 |
| 15 Jun 2017 | Plum 360 Infusion System | ICU Medical Inc | Device | Class II | 1 |
| 15 Jun 2017 | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 | Boston Scientific Corporation | Device | Class II | 1 |
| 15 Jun 2017 | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety… (77962) | Custom Assemblies Inc | Device | Class II | 1 |
| 15 Jun 2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01 | Hospira a Pfizer Company | Drug | Class II | 4 |
| 15 Jun 2017 | DFS Cranberry Pumpkin Salad. Contains 4 / 8 Lb Bags, Net WT 32 lbs Item # 12071, Manufactured for Direct Food Service by Dawns Foods - Portage, WI. | Morski Brands Inc. dba Dawn's Fresh Foods | Food | Class I | 1 |
| 15 Jun 2017 | Nature s Promise Organic Campfire Trail Mix 12oz. | United Natural Trading Inc. dba Woodstock Farms | Food | Class I | 9 |
| 14 Jun 2017 | Bhufit Bar Apple Chunk Cinnamon Nutmeg; Vegan Organic Pea Protein Net Wt. 1.6 oz (45G) | Individual firm, name withheld | Food | Class I | 9 |
| 13 Jun 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with… | Cyberonics, Inc | Device | Class II | 2 |
| 13 Jun 2017 | NutiLight Protein + Pistachio Spread, Net WT 11oz (312gr), NATUREFOOD 2010 COMPANY, PALM COAST, FL 32137 USA (77622) | Naturefood 2010 Company | Food | Class I | 1 |
| 13 Jun 2017 | North Atlantic Brand - Approx8OZ Raw Breaded Swai Fillet - NET WT. 10lbs (4.54KG) | Channel Fish Processing Co. Inc | Food | Class III | 57 |
| 12 Jun 2017 | INVUITY(R) PhotonBlade(TM), REF PB1 (77607) | Invuity, Inc. | Device | Class II | 1 |
| 9 Jun 2017 | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. | Sorin Group USA, Inc. | Device | Class II | 1 |
| 9 Jun 2017 | Best Choice 12/12oz Breaded Minced Fish Sticks; Item Number: B1000 | High Liner Foods Inc. | Food | Class II | 186 |
| 8 Jun 2017 | 1) Key Lime Dessert Cake, Grandma's Bake Shoppe, NET WT. 14 OZ. (400 g), UPC 8 24153 02582 2 (77516) | Beatrice Bakery Co | Food | Class II | 1 |
| 7 Jun 2017 | Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027 | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 7 Jun 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices | Cenorin, LLC | Device | Class II | 3 |
| 6 Jun 2017 | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions | Spectranetics Corporation | Device | Class II | 1 |
| 2 Jun 2017 | BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which… | C.R. Bard, Inc. | Device | Class II | 1 |
| 1 Jun 2017 | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction. | Shippert Medical Technologies | Device | Class II | 7 |
| 1 Jun 2017 | VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy). | Solta Medical Inc | Device | Class II | 2 |
| 31 May 2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening. | PerkinElmer Health Sciences, Inc. | Device | Class III | 1 |
| 31 May 2017 | SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, | Soft Computer Consultants, Inc. | Device | Class II | 1 |
| 25 May 2017 | Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial… | Atrium Medical Corporation | Device | Class II | 1 |
| 25 May 2017 | CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987 (77375) | Individual firm, name withheld | Drug | Class I | 1 |
| 23 May 2017 | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from… | Pentax of America Inc | Device | Class II | 2 |
| 22 May 2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in… | Sentinel CH SPA | Device | Class II | 1 |
| 22 May 2017 | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076 (77357) | Global Marketing Enterprises, Inc. | Drug | Class II | 1 |
| 21 May 2017 | Cashews, Whole Roasted & Salted: Organic Roasted & Salted Whole Cashews, Net weight 12 lb. and 25 lb. vacuum packed cartons (Wholesale) and Whole Roasted & Salted Cashews | HVF Inc. d.b.a Huson Valley Farms | Food | Class I | 51 |
| 19 May 2017 | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation… | Fisher Diagnostics | Device | Class II | 2 |
| 19 May 2017 | Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004 (77333) | Individual firm, name withheld | Drug | Class I | 1 |
| 17 May 2017 | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 | X-Gen Pharmaceuticals Inc. | Drug | Class II | 1 |
| 16 May 2017 | VITEK 2 Gram Negative test kits containing colistin (cs01n) | Biomerieux Inc | Device | Class II | 1 |
| 16 May 2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 (77323) | Lupin Limited (Unit 1) | Drug | Class I | 1 |
| 11 May 2017 | Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images,… | GE Medical Systems, LLC | Device | Class II | 9 |
| 11 May 2017 | Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485. (77760) | AtHome Medical, Inc. | Drug | Class II | 1 |
| 10 May 2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 3 |
| 5 May 2017 | GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842 (77208) | Genetic Edge Compounds LLC | Drug | Class I | 1 |
| 3 May 2017 | Nelson's Dutch Farms; Butterscotch Vanilla; Half Gallon Nelson's Ice Cream, Inc., Royersford, PA 19468. Merrymead Farm Market Premium Ice Cream; Butterscotch Vanilla; Half Gallon; Dist by: Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA; | Nelson's Creamery, LLC. | Food | Class II | 11 |
| 24 Apr 2017 | Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 (77712) | Konica Minolta, Inc. | Device | Class II | 1 |
| 20 Apr 2017 | Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10 | Individual firm, name withheld | Drug | Class I | 6 |
| 20 Apr 2017 | Lam Sheng Kee Frozen Fried Tofu NET Weight 240g(8.5 OZ) | Global Lam Sheng Kee inc. | Food | Class I | 3 |
| 19 Apr 2017 | Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail. | Ortho Solutions Inc | Device | Class II | 1 |
| 31 Mar 2017 | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US | C.R. Bard, Inc. | Device | Class II | 1 |
| 30 Mar 2017 | Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194 | Bayer HealthCare Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 22 Mar 2017 | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy… | Cook Medical Incorporated | Device | Class I | 1 |
| 17 Mar 2017 | DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead… (77839) | Individual firm, name withheld | Device | Class II | 1 |
| 2 Mar 2017 | Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels (77508) | Myelotec, Inc. | Device | Class II | 1 |
| 15 Feb 2017 | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip… | Greatbatch Medical | Device | Class II | 1 |
| 9 Dec 2016 | Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 11 Nov 2016 | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 | Greatbatch Medical | Device | Class II | 1 |
| 11 Oct 2016 | ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 20 Jan 2016 | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead… | Magellan Diagnostics, Inc. | Device | Class II | 1 |