| 7 Jun 2013 | VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10. | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 7 Jun 2013 | vega one, all-in one nutrition bar; chocolate almond flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut… | Sequel Naturals Ltd | Food | Class I | 5 |
| 6 Jun 2013 | 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02 | Hospira Inc. | Drug | Class II | 1 |
| 6 Jun 2013 | ALL NATURAL Julian's RECIPE European Style Pretzel Baguette, BUTTER & SEA SALT, NET WT 11.3 OZ (320 g), UPC 8 55971 00226 9, 2 BAGUETTES, KEEP FROZEN -- Product of Germany. Manufactured for Distribution by Julian's Recipe, LLC PO Box 323, Montgomery, NY 12549. --- The product consists of a frozen pre-baked baguette… (65460) | Julian's Recipe, LLC | Food | Class I | 1 |
| 4 Jun 2013 | Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and… (65374) | Utah Medical Products, Inc | Device | Class II | 1 |
| 4 Jun 2013 | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717… | Respironics California Inc | Device | Class I | 1 |
| 4 Jun 2013 | Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03… (65275) | Pharmacia & Upjohn LLC | Drug | Class II | 1 |
| 3 Jun 2013 | Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc. | Actavis | Drug | Class III | 1 |
| 31 May 2013 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. | Pfizer Inc | Drug | Class III | 1 |
| 31 May 2013 | Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:"uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www.vegancookies.com***". (65335) | International Desserts and Delicacies | Food | Class I | 1 |
| 31 May 2013 | Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 40052 6. Individual bar: Oskri Sesame Bar With Date Syrup,Gluten Free, Net WT 1.9 oz (53g) | Oskri Corp. | Food | Class II | 1 |
| 30 May 2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box) | Sandoz Incorporated | Drug | Class II | 1 |
| 29 May 2013 | ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 29 May 2013 | Lightlife Farmer's Market Veggie Burgers, meat free, 12 oz/4-count bag, packaged in 5/12 oz-bag/cartons. Distributed By: Lightlife Foods, Turners Falls, MA. Case UPC Code: 20043454805252 | Conagra Inc | Food | Class I | 1 |
| 28 May 2013 | BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 28 May 2013 | StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures. (65283) | Dental EZ Stardental Division | Device | Class II | 1 |
| 28 May 2013 | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. | Abbott Medical Optics, Inc. | Device | Class II | 3 |
| 28 May 2013 | Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 28 May 2013 | Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g) (65349) | Faria Limited LLC dba Sheffield Pharmaceuticals | Drug | Class III | 1 |
| 28 May 2013 | Fresh Thai chili peppers. Loose fresh Thai chili peppers packaged with inner plastic mesh bag into paper carton cardboard boxes. Imported bulk. Outer carton labeling reads in part: "***PRODUCE OF MEXICO***JAMMIN PEPPERS***THAI CHILI***DISTRIBUTED BY: JT BROKERAGE 651 KOHLER ST. LOS ANGELES, CA… (65299) | Fruit Treasure Inc | Food | Class I | 1 |
| 28 May 2013 | MINUTE MAID ORANGE JUICE, 10oz and 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. | Coca-Cola Refreshments USA, Inc. | Food | Class II | 5 |
| 24 May 2013 | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or… | Gyrus Acmi, Incorporated | Device | Class II | 1 |
| 24 May 2013 | AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. | Fenwal Inc | Device | Class II | 1 |
| 24 May 2013 | VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102). (65341) | International Biomedical, Ltd. | Device | Class II | 1 |
| 24 May 2013 | Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton. The product is sold in a seafood retail case. Product labeled as:"WILD WHITE EZ PEEL SHRIMP 16/20 CT WILD CAUGHT PRODUCT OF USA CHEM FREE INGREDIENTS:… (65291) | Blessing Seafood, Inc. | Food | Class I | 1 |
| 23 May 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 16 |
| 23 May 2013 | BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. | Prism Medical Services USA | Device | Class II | 4 |
| 22 May 2013 | Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 24 OZ (680 g), UPC… | HP Hood LLC | Food | Class II | 3 |
| 21 May 2013 | Roo's Juice Tropical Orange Flavor (5% juice beverage) 10 FL OZ. (296 mL) Distributed by The Pantry, Inc. Sanford, NC 27330 (65230) | Jus Made, Inc | Food | Class II | 1 |
| 18 May 2013 | White Farm Enriched White Bread. 16 oz (454g), 9pc/box. UPC 0 10314 10002 0. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner. | LL Bakery, Inc. | Food | Class I | 3 |
| 16 May 2013 | Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 | Hospira Inc. | Drug | Class II | 1 |
| 15 May 2013 | AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest,… | AGFA Corp. | Device | Class II | 1 |
| 15 May 2013 | Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures. (65160) | Maytex Corp | Device | Class II | 1 |
| 15 May 2013 | Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. | Biomet, Inc. | Device | Class II | 1 |
| 15 May 2013 | Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132 | Pentec Health | Drug | Class II | 15 |
| 15 May 2013 | ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.). Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers. UPC Code: 6 1300871981 4. (65186) | Arizona Beverages USA LLC | Food | Class III | 1 |
| 15 May 2013 | GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com; (65211) | Arthur Schuman Midwest LLC | Food | Class I | 1 |
| 14 May 2013 | QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 14 May 2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. | Optovue, Inc. | Device | Class III | 1 |
| 14 May 2013 | ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 14 May 2013 | Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support. | GE Healthcare, LLC | Device | Class II | 1 |
| 13 May 2013 | Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction. (65248) | Endologix Inc | Device | Class I | 1 |
| 13 May 2013 | ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples,… | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 13 May 2013 | Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and… | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 10 May 2013 | Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit… | Symbios Medical Products, LLC | Device | Class I | 11 |
| 10 May 2013 | Smiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets) Product in plastic snap-lid containers. (65174) | Smiling Hill Farm, Inc. dba Silvery Moon Creamery | Food | Class II | 1 |
| 10 May 2013 | Ginseng. American Ginseng , 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk products are not labeled. (65208) | Bao Gong Da Inc | Food | Class III | 1 |
| 10 May 2013 | Gromex Camaron Entero (Whole Shrimp) Net Wt. 1 1/2 oz. 43 First St., Passaic, NJ 07055 (973) 458-9399 | Gromex Inc. | Food | Class II | 2 |
| 9 May 2013 | GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3… | GE Healthcare, LLC | Device | Class II | 1 |
| 8 May 2013 | 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 8 May 2013 | 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 8 May 2013 | GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. The GlideScope Video Laryngoscopes… | Verathon, Inc. | Device | Class I | 1 |
| 8 May 2013 | IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart (65142) | Dairy Fresh LLC | Food | Class I | 1 |
| 8 May 2013 | Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk) | Whole Foods Market Group Inc. | Food | Class I | 2 |
| 7 May 2013 | The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities | Zimmer Surgical Inc | Device | Class II | 3 |
| 7 May 2013 | Market Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY, May contain tree nuts, milk, wheat and eggs. Distributed by Target Corporation, Minneapolis, MN 55403. | American Importing Co, Inc | Food | Class II | 1 |
| 6 May 2013 | da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 6 May 2013 | Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments. | Alphatec Spine, Inc. | Device | Class II | 1 |
| 6 May 2013 | Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. | Covidien LP | Device | Class II | 6 |
| 6 May 2013 | Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz bottles= 1 case. (65117) | National Food & Beverage, Inc | Food | Class III | 1 |
| 4 May 2013 | Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle. (65059) | Pure Herbs Ltd | Food | Class I | 1 |
| 3 May 2013 | DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 3 May 2013 | Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062 (65134) | Individual firm, name withheld | Food | Class II | 1 |
| 3 May 2013 | Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic (65201) | Berkshire Cheese LLC | Food | Class III | 1 |
| 2 May 2013 | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 May 2013 | Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 2 May 2013 | Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL | THE COMPOUNDING SHOP, INC. | Drug | Class II | 25 |
| 2 May 2013 | Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in parts: "***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO. 1***Hazelnut Growers of Oregon***401 N. 26… (65099) | Hazelnut Growers of Oregon | Food | Class I | 1 |
| 2 May 2013 | DiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484 | Nestle USA, Inc - Northbrook Pizza Head Office | Food | Class II | 2 |
| 1 May 2013 | Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. | Applied Medical Resources Corp | Device | Class II | 1 |
| 1 May 2013 | XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles (65128) | Atlantic Pro Nutrients, Inc. dba XYMOGEN | Food | Class I | 1 |
| 30 Apr 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive… | American Optisurgical Inc | Device | Class II | 1 |
| 30 Apr 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number:… | Angiodynamics, Inc. | Device | Class II | 2 |
| 30 Apr 2013 | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage. | Nephron Pharmaceuticals Corp. | Device | Class I | 3 |
| 30 Apr 2013 | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring. | TZ Medical Inc. | Device | Class II | 1 |
| 30 Apr 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical Inc | Device | Class II | 1 |
| 30 Apr 2013 | SlingBar 350. Designed to meet the needs for lifting humans. | Hill-Rom, Inc. | Device | Class II | 4 |
| 30 Apr 2013 | Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. | Elekta, Inc. | Device | Class II | 1 |
| 30 Apr 2013 | DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32 | Hospira Inc. | Drug | Class II | 1 |
| 30 Apr 2013 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16 | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 29 Apr 2013 | Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction… | Biomet, Inc. | Device | Class II | 1 |
| 26 Apr 2013 | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. | Heart Sync, Inc | Device | Class II | 2 |
| 26 Apr 2013 | AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood. | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Apr 2013 | Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. | Biomet, Inc. | Device | Class II | 1 |
| 26 Apr 2013 | Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 25 Apr 2013 | BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 24 Apr 2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The… (65175) | Embla System Llc | Device | Class II | 1 |
| 23 Apr 2013 | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. | Cordis Corporation | Device | Class II | 5 |
| 23 Apr 2013 | 7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK (65003) | 7-Eleven Stores of Oklahoma | Food | Class I | 1 |
| 22 Apr 2013 | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The… | Fisher & Paykel Healthcare, Ltd. | Device | Class II | 1 |
| 22 Apr 2013 | Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 22 Apr 2013 | Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, | Nora Apothecary and Alternative Therapies, Inc. | Drug | Class II | 43 |
| 19 Apr 2013 | 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric… | OrthoPediatrics Corp | Device | Class II | 3 |
| 18 Apr 2013 | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified… | Carl Zeiss Meditec, Inc. | Device | Class II | 1 |
| 17 Apr 2013 | The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery. (65006) | Alcon Grieshaber AG | Device | Class II | 1 |
| 17 Apr 2013 | Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate… | Beckman Coulter Inc. | Device | Class II | 1 |
| 16 Apr 2013 | BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 16 Apr 2013 | Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only. | Alere San Diego, Inc. | Device | Class II | 1 |
| 15 Apr 2013 | Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. | Hill-Rom, Inc. | Device | Class II | 1 |
| 15 Apr 2013 | Meijer Diced Pears in Fruit Juice 8oz cup | Meijer Distribution, Inc | Food | Class III | 3 |
| 12 Apr 2013 | BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. | Becton Dickinson & Co. | Device | Class II | 2 |
| 12 Apr 2013 | next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods (65203) | Tropical Valley Foods, Inc. | Food | Class I | 1 |
| 9 Apr 2013 | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV,… (65171) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Apr 2013 | Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India | Aurobindo Pharma USA Inc | Drug | Class III | 1 |
| 4 Apr 2013 | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood | Polymer Technology Systems, Inc. | Device | Class II | 1 |
| 4 Apr 2013 | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 4 Apr 2013 | QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. | Intel-GE Care Innovations LLC | Device | Class II | 2 |
| 2 Apr 2013 | All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme UPC 6-09492 72000-9 : | Chemi- Source Inc, Nutra Pak | Food | Class II | 26 |
| 1 Apr 2013 | VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 30 Mar 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. | American Optisurgical Inc | Device | Class II | 1 |
| 27 Mar 2013 | NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia. | Zimmer, Inc. | Device | Class II | 1 |
| 27 Mar 2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60 | Legacy Pharmaceutical Packaging LLC | Drug | Class III | 1 |
| 19 Mar 2013 | Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01 | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 18 Mar 2013 | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency . | Shimadzu Medical Systems | Device | Class II | 1 |
| 18 Mar 2013 | Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA | Physicians Total Care, Inc. | Drug | Class III | 1 |
| 14 Mar 2013 | Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66 | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 2 |
| 12 Mar 2013 | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables | Berchtold Corp. | Device | Class II | 1 |
| 12 Mar 2013 | Chicken Noodle Soup Mix, "9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8 and World's Best Teacher UPC 7 92290… | Purely American, Inc. | Food | Class II | 11 |
| 11 Mar 2013 | Golden Flower Dried Ginger Net Wt. 6 oz (170g). Packed By: S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China. Distributed by: Prosperity Resources Int'l., Inc. USA. Product of China. (65030) | Prosperity Resources International, Inc. | Food | Class III | 1 |
| 8 Mar 2013 | MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel… (64856) | Linde Gas North America Llc | Device | Class II | 1 |
| 4 Mar 2013 | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal… | Medtronic Xomed, Inc. | Device | Class I | 1 |
| 2 Mar 2013 | Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00 | Physicians Total Care, Inc. | Drug | Class III | 1 |
| 22 Feb 2013 | Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides. (33728) | Aperio Technologies Inc | Device | Class II | 1 |
| 22 Feb 2013 | Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 22 Feb 2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN (64635) | Petnet Solution Inc | Drug | Class II | 1 |
| 20 Feb 2013 | Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360… | Orthopedic Alliance LLC | Device | Class II | 9 |
| 20 Feb 2013 | 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the… | Spinal Solutions, LLC | Device | Class II | 10 |
| 19 Feb 2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument. | Tecan US, Inc. | Device | Class II | 1 |
| 19 Feb 2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged… | Novartis Consumer Health | Drug | Class III | 5 |
| 15 Feb 2013 | RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 14 Feb 2013 | Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress. | Zimmer, Inc. | Device | Class II | 1 |
| 12 Feb 2013 | MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL (64409) | OLAAX International | Drug | Class I | 1 |
| 31 Jan 2013 | Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems… | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 30 Jan 2013 | AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04 | TG United, Inc. | Drug | Class II | 44 |
| 24 Jan 2013 | User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 23 Jan 2013 | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0… | Bard Peripheral Vascular Inc | Device | Class II | 4 |
| 23 Jan 2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | Bion Enterprises Ltd | Device | Class III | 3 |
| 23 Jan 2013 | Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE (64149) | Mission Pharmacal Co | Drug | Class III | 1 |
| 17 Jan 2013 | SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the… | Ormco/Sybronendo | Device | Class II | 2 |
| 16 Jan 2013 | Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics. | Philips Healthcare Inc. | Device | Class II | 2 |
| 16 Jan 2013 | Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications | Philips Healthcare Inc. | Device | Class II | 2 |
| 2 Jan 2013 | "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)" is displayed on the carton's label in error. The lid bears the label "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS (1.661L)". The product bears UPC… (64016) | Individual firm, name withheld | Food | Class I | 1 |
| 28 Dec 2012 | Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013 (63988) | Advance Pharmaceutical Inc | Drug | Class I | 1 |
| 11 Dec 2012 | Natures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106 | Whole Foods Market | Food | Class II | 1 |
| 5 Dec 2012 | Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. (65082) | Canon Inc. | Device | Class II | 1 |
| 19 Nov 2012 | The product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled "Karol" with the Lot No. "01W45" stamped in the upper, right-hand corner on the face of the box. The box states "Distributed by Interstate Fruit & Vegetable", which is an affiliated business of Rio Queen Citrus, Inc. These… (63738) | Rio Queen Citrus, Inc | Food | Class I | 1 |
| 10 Nov 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | Orthovita, Inc., dBA Stryker Orthobiologics. | Device | Class II | 13 |
| 24 Sep 2012 | Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads "mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-" PLU 22096100000 | The Sourdough: A European Bakery Inc. | Food | Class I | 3 |
| 24 Sep 2012 | Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 | Pecan Deluxe Candy Company | Food | Class I | 5 |
| 20 Sep 2012 | Maple Macadamia Nuts, 25 lb bulk boxes (63366) | Nature's Candy, Inc. | Food | Class I | 1 |
| 2 Aug 2012 | E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology (64927) | Kreg Medical Inc. | Device | Class II | 1 |
| 1 Jun 2012 | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission. | I-Flow LLC | Device | Class II | 2 |
| 29 May 2012 | IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms (65245) | IDEV Technologies, Inc. | Device | Class II | 1 |
| 16 Apr 2012 | Preserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar. Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203. Product of Vietnam. (61696) | Hong Lee Trading Inc | Food | Class I | 1 |
| 13 Oct 2011 | Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 23 Sep 2011 | Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 19 Sep 2011 | Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body. | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 6 Apr 2011 | Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg.… | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 4 Mar 2011 | ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 7 Apr 2009 | Trophy Nut Brand 1.5 oz. tube; Trophy Nut Brand 1.25 oz. tube; Nut Barrel Brand 5 oz. Fundraising bag; and Nut Barrel Brand 1.25 oz. tube. | Trophy Nut Co Inc | Food | Class I | 5 |
| 4 Mar 2009 | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal… (65289) | Invatec Llc | Device | Class II | 1 |
| 10 May 2008 | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. | SpineFrontier, Inc. | Device | Class II | 1 |