| 11 Feb 2013 | Monaco RTP System. Radiation treatment planning. | Elekta, Inc. | Device | Class II | 1 |
| 8 Feb 2013 | Lean Cuisine Culinary Collection Mushroom Mezzaluna Ravioli ravioli filled with portobello & button mushrooms, romano & ricotta cheeses in a creamy marsala wine sauce with spinach & red peppers no preservatives, NET WT 8 5/8 oz (244g) 0 13800 58358 1 DISTRIBUTED BY: NESTLE' USA, INC., SOLON, OH 44139 | Nestle USA | Food | Class II | 1 |
| 6 Feb 2013 | CULINARY Creations (brand) CHEESY BROCCOLI SOUP, 3F3080, CONTAINS: 20/2 LB. CHUBS, NET WT. 40 LBS. 91816 KG), DIVERSIFIED FOODS AND SEASONINGS, INC, 1115 N. CAUSEWAY BLVD. STE.200, MANDEVILLE, LA 70471 1-800-835-3374, FOR INSTITUTIONAL USE ONLY, UPC 00732628330803 (64297) | Diversified Foods & Seasonings, Inc. | Food | Class I | 1 |
| 4 Feb 2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. | Ultradent Products, Inc. | Device | Class III | 2 |
| 1 Feb 2013 | VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 30 Jan 2013 | Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05. | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 30 Jan 2013 | A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site) | Tumalo Farms LLC | Food | Class II | 2 |
| 29 Jan 2013 | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or… | Vascular Solutions, Inc. | Device | Class II | 1 |
| 28 Jan 2013 | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 28 Jan 2013 | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. | ConMed Corporation | Device | Class II | 2 |
| 28 Jan 2013 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation | Philips Healthcare Inc. | Device | Class II | 1 |
| 28 Jan 2013 | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90. | Stat Rx USA | Drug | Class III | 1 |
| 28 Jan 2013 | Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons) (35782) | Altiza Inc. | Food | Class I | 1 |
| 28 Jan 2013 | Labeled in part: "All Natural Chia ReCharged Stix Mix***Chia Seed Sticks***Net Wt. 5oz", UPC Code: 0 94184 01014 6 (64289) | Tropical Nut & Fruit Co., Inc. | Food | Class I | 1 |
| 23 Jan 2013 | Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02 (64137) | Procter & Gamble Hair Care Llc | Drug | Class III | 1 |
| 22 Jan 2013 | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ | Sandoz Incorporated | Drug | Class III | 1 |
| 22 Jan 2013 | Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710 | Annie's Homegrown Inc | Food | Class II | 3 |
| 20 Jan 2013 | Knott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE 38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326 (64138) | Knotts Wholesale Foods Inc | Food | Class I | 1 |
| 19 Jan 2013 | Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated. Product of Guatemala UPC 7 16519 13004 Distributed by Mann Packing, Salinas, CA. (64161) | Mann Packing Co Inc | Food | Class III | 1 |
| 19 Jan 2013 | Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482 | Pamela's Products, Inc. | Food | Class II | 4 |
| 18 Jan 2013 | Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position. (64110) | CHENICA INC. | Device | Class II | 1 |
| 18 Jan 2013 | St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects… | St Jude Medical Inc | Device | Class I | 1 |
| 17 Jan 2013 | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography | Carestream Health, Inc. | Device | Class III | 1 |
| 17 Jan 2013 | Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9 (64184) | United Natural Foods, Inc. - Greenwood | Food | Class I | 1 |
| 16 Jan 2013 | Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications | Philips Healthcare Inc. | Device | Class II | 1 |
| 16 Jan 2013 | Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 16 Jan 2013 | 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving… | Greatbatch Medical | Device | Class II | 1 |
| 16 Jan 2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30. (64151) | Actelion Pharmaceuticals U.S., Inc. | Drug | Class III | 1 |
| 16 Jan 2013 | Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 16 Jan 2013 | Thomas' Bagels, 1 lb 4 oz packages; EVERYTHING, ONION, BLUEBERRY, PLAIN, CINNAMON RAISIN, HEARTY GRAINS 100% WHOLE WHEAT, CINNAMON SWIRL and HONEY WHEAT varieties. | Bimbo Bakeries Usa | Food | Class II | 4 |
| 15 Jan 2013 | Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name "Dried Preserved Plum" and Net Weight 44 lbs. (Product was… (64179) | Nuera Trading Company Incorporated | Food | Class II | 1 |
| 15 Jan 2013 | DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990. | Belmont Confections Inc | Food | Class I | 2 |
| 14 Jan 2013 | Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases. (64057) | Oxus America, Inc. | Device | Class II | 1 |
| 14 Jan 2013 | P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system. (64099) | Tobii Assistive Technology, Inc. | Device | Class II | 1 |
| 14 Jan 2013 | Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare… | Philips Healthcare Inc. | Device | Class II | 1 |
| 14 Jan 2013 | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). | Ansell Healthcare Products LLC | Device | Class II | 1 |
| 14 Jan 2013 | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. | Breg Inc | Device | Class II | 2 |
| 11 Jan 2013 | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | Codman & Shurtleff, Inc. | Device | Class II | 24 |
| 11 Jan 2013 | Spice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188. (64080) | Jiffy Food Service, LLC | Food | Class I | 1 |
| 11 Jan 2013 | Ocean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc. | Dawn's Foods, Inc. | Food | Class II | 7 |
| 9 Jan 2013 | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. (63875) | Envoy Medical Corporation | Device | Class II | 1 |
| 9 Jan 2013 | Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed (64227) | Penzeys LTD | Food | Class II | 1 |
| 8 Jan 2013 | SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures. (64069) | Allergen Medical | Device | Class II | 1 |
| 8 Jan 2013 | Yangchun Noodles, 10 case, 12 bgs per case (35908) | Man Fon Inc | Food | Class II | 1 |
| 8 Jan 2013 | Island Delights Coconut Haystack Candy Maple Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***NATURAL MAPLE FLAVOR***Island Delights, Inc. Seville, OH 44273" | Island Delights, Inc. | Food | Class I | 4 |
| 7 Jan 2013 | Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01. | West-ward Pharmaceutical Corp. | Drug | Class III | 1 |
| 4 Jan 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | DePuy Orthopaedics, Inc. | Device | Class I | 4 |
| 4 Jan 2013 | Kinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9 (64059) | KeHE/Tree of life Bloomington | Food | Class I | 1 |
| 3 Jan 2013 | TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws,… | Biomet, Inc. | Device | Class II | 1 |
| 3 Jan 2013 | Kitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628 | C H S Inc | Food | Class II | 1 |
| 2 Jan 2013 | The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. | Lumenis Limited | Device | Class I | 1 |
| 2 Jan 2013 | Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762. | Star Snacks Co., Llc. | Food | Class II | 1 |
| 2 Jan 2013 | Growth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow. Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers,… (64011) | EonNutra, LLC | Food | Class II | 1 |
| 2 Jan 2013 | Food Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL. | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 31 Dec 2012 | Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens. | Diagnostic Hybrids Inc | Device | Class III | 1 |
| 31 Dec 2012 | Kinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600. | Unified Grocers Inc. | Food | Class I | 1 |
| 31 Dec 2012 | Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case (63996) | Jerusalem Manufacturing Natural Foods & Wholesalers, Inc. | Food | Class I | 1 |
| 28 Dec 2012 | HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03 (64020) | Individual firm, name withheld | Drug | Class II | 1 |
| 27 Dec 2012 | Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14. | Ranbaxy Inc. | Drug | Class III | 2 |
| 26 Dec 2012 | Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 26 Dec 2012 | Chocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package) or in 0.5 lb and 1 lb. boxes. The 2-ounce package has a UPC 19815 90007 8. There is no UPC for 0.5 lb. and 1 lb. packages. The product is labeled in parts: "***Chocolate Covered Coconut Balls***CHOCOLATE DECADENCE***Net Wt.… (63982) | Individual firm, name withheld | Food | Class II | 1 |
| 25 Dec 2012 | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. | bioMerieux, Inc. | Device | Class II | 1 |
| 24 Dec 2012 | ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Raw | Hoop Nuts LLC DBA Christophers Nut Co | Food | Class I | 2 |
| 21 Dec 2012 | MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 21 Dec 2012 | OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France (64132) | Hitachi Chemical Diagnostics Inc | Device | Class III | 1 |
| 21 Dec 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0… (64180) | Lee Pharmaceuticals, Inc | Drug | Class II | 1 |
| 21 Dec 2012 | Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738 | Warner Chilcott Company LLC | Drug | Class III | 2 |
| 21 Dec 2012 | MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487 | NBTY Inc. | Food | Class III | 2 |
| 21 Dec 2012 | "ESTRELLA***Empanadillas de Pizza" (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***". | Suadel Food Products, Inc. | Food | Class I | 6 |
| 20 Dec 2012 | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. (63933) | Healthtronics, Inc. | Device | Class II | 1 |
| 20 Dec 2012 | CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. | Carefusion 303 Inc | Device | Class II | 1 |
| 20 Dec 2012 | Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 19 Dec 2012 | HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics | Hamilton Medical Inc | Device | Class I | 1 |
| 19 Dec 2012 | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. (63942) | P & J Trading Co | Drug | Class I | 1 |
| 18 Dec 2012 | Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90. (64056) | Watson Pharmaceuticals | Drug | Class II | 1 |
| 18 Dec 2012 | Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0. (63917) | Matrixx Initiatives Inc | Drug | Class I | 1 |
| 18 Dec 2012 | Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China. | Tristar Food Wholesale Co Inc | Food | Class II | 1 |
| 17 Dec 2012 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin. | Animas Corporation | Device | Class III | 1 |
| 17 Dec 2012 | Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. | Medacta Usa Inc | Device | Class II | 1 |
| 17 Dec 2012 | Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. (63991) | Individual firm, name withheld | Device | Class II | 1 |
| 14 Dec 2012 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class I | 1 |
| 14 Dec 2012 | Individual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: "The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.*** | The Father's Table, LLC | Food | Class III | 2 |
| 13 Dec 2012 | Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 13 Dec 2012 | Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use | Philips Healthcare Inc. | Device | Class II | 1 |
| 13 Dec 2012 | ***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***. (64082) | Gordon Food Service, Inc. | Food | Class II | 1 |
| 12 Dec 2012 | Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. | Ormco/Sybronendo | Device | Class II | 1 |
| 12 Dec 2012 | Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033 (63879) | Schering-Plough Products, LLC | Drug | Class II | 1 |
| 10 Dec 2012 | BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to… | Becton Dickinson & Co. | Device | Class II | 1 |
| 10 Dec 2012 | Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000 | General Mills, Inc | Food | Class II | 1 |
| 7 Dec 2012 | Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 6 Dec 2012 | Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26;… | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Drug | Class I | 1 |
| 5 Dec 2012 | PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 3 Dec 2012 | Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. | Quidel Corporation | Device | Class II | 1 |
| 30 Nov 2012 | Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 97208 U.S.A.***Product of China***0 15400… (63798) | Acme Food Sales, Inc | Food | Class III | 1 |
| 28 Nov 2012 | COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 28 Nov 2012 | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked… | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class II | 1 |
| 26 Nov 2012 | Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. | Custom Healthcare Systems, Inc. | Device | Class II | 2 |
| 21 Nov 2012 | Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany). | Bracco Diagnostic Inc | Drug | Class I | 2 |
| 20 Nov 2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9 | Upsher Smith Laboratories, Inc. | Drug | Class II | 1 |
| 20 Nov 2012 | Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259 (64047) | Individual firm, name withheld | Food | Class III | 1 |
| 19 Nov 2012 | EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215*** (64116) | Ascend Therapeutics Inc | Drug | Class III | 1 |
| 15 Nov 2012 | ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 15 Nov 2012 | Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. | Viterion TeleHealthcare Llc | Device | Class II | 3 |
| 15 Nov 2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc.,… | Hospira Inc. | Drug | Class II | 1 |
| 12 Nov 2012 | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL | Becton Dickinson & Company | Device | Class II | 1 |
| 8 Nov 2012 | Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56. | Hospira Inc. | Drug | Class I | 2 |
| 6 Nov 2012 | Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545 | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 5 Nov 2012 | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients. | Medrad Inc | Device | Class II | 1 |
| 5 Nov 2012 | Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. | Exactech, Inc. | Device | Class II | 2 |
| 31 Oct 2012 | Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko… | Hill-Rom, Inc. | Device | Class II | 1 |
| 31 Oct 2012 | WP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz. | J F C International Inc | Food | Class III | 2 |
| 29 Oct 2012 | Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures. | Cordis Corporation | Device | Class II | 1 |
| 23 Oct 2012 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01 | Estee Lauder Inc | Drug | Class III | 1 |
| 22 Oct 2012 | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine… | Alere San Diego, Inc. | Device | Class III | 2 |
| 15 Oct 2012 | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. | GE Healthcare, LLC | Device | Class I | 2 |
| 12 Oct 2012 | Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications. | MOOG Medical Devices Group | Device | Class II | 1 |
| 12 Oct 2012 | Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 10 Oct 2012 | The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples. | Remel Inc | Device | Class II | 1 |
| 10 Oct 2012 | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry… (63866) | Alfa Wassermann, Inc. | Device | Class II | 1 |
| 28 Sep 2012 | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or… (64076) | International Technidyne Corp. | Device | Class II | 1 |
| 24 Sep 2012 | PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. | Winco Mfg., LLC | Device | Class II | 4 |
| 20 Sep 2012 | SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873 (63048) | Globe All Wellness, LLC | Drug | Class I | 1 |
| 14 Sep 2012 | Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. | Zimmer, Inc. | Device | Class II | 8 |
| 10 Sep 2012 | Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position. | Invacare Corporation | Device | Class II | 1 |
| 5 Sep 2012 | Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 5 Sep 2012 | Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class II | 1 |
| 30 Aug 2012 | STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor). | Stryker Sustainability Solutions | Device | Class II | 1 |
| 21 Aug 2012 | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used… | Remel Inc | Device | Class II | 1 |
| 21 Aug 2012 | Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK. | Remel Inc | Device | Class II | 1 |
| 20 Aug 2012 | Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for… | Remel Inc | Device | Class II | 2 |
| 14 Aug 2012 | THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump. (63390) | Lansinoh Laboratories Inc | Device | Class II | 1 |
| 6 Aug 2012 | Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical… | Synthes USA HQ, Inc. | Device | Class II | 2 |
| 13 Jun 2012 | GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Jun 2012 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. | GE Healthcare, LLC | Device | Class II | 1 |
| 4 Jun 2012 | Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. | Aesculap, Inc. | Device | Class II | 1 |
| 31 May 2012 | Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2 | Bayer HealthCare Pharmaceuticals Inc. | Drug | Class III | 1 |
| 24 May 2012 | AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. | GE Healthcare, LLC | Device | Class II | 1 |
| 15 May 2012 | Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800 (63201) | Miami Growers Inc. | Food | Class III | 1 |
| 2 May 2012 | HEB Deli General Joes Chicken Entree, UPC 0026966900000; HEB Deli HE Bowl General Joes Chicken, UPC 0026967400000; HEB Deli General Joe's Chicken Retail Pack, UPC 0026520900000; HEB Deli General Joes Chicken UPC 0026703700000 | He Butt Grocery Company | Food | Class I | 4 |
| 27 Apr 2012 | Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products (61870) | Motorola Inc | Device | Class II | 1 |
| 18 Apr 2012 | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On… | Bacterin International, Inc. | Device | Class II | 1 |
| 12 Apr 2012 | Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. | Varian Medical Systems, Inc. | Device | Class II | 2 |
| 22 Mar 2012 | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device. | Extremity Medical LLC | Device | Class II | 1 |
| 30 Nov 2011 | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system. (60906) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Sep 2011 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient… | GE Healthcare, LLC | Device | Class II | 1 |
| 1 Nov 2010 | Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 21 Jan 2010 | Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS (64029) | Lockheed Martin Gyrocam Systems, Inc. | Device | Class II | 1 |
| 30 Nov 2009 | Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340,… | NAImco Inc dba Richmar Inc | Device | Class II | 4 |