| 15 May 2013 | Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 8 May 2013 | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique. | DePuy Orthopaedics, Inc. | Device | Class III | 1 |
| 7 May 2013 | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. | Medical Information Technology, Inc. | Device | Class II | 1 |
| 3 May 2013 | PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications | ConMed Corporation | Device | Class II | 1 |
| 3 May 2013 | Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case. (65153) | Gruma Corp | Food | Class II | 1 |
| 1 May 2013 | Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024*** | Eastland Food Corporation | Food | Class II | 1 |
| 30 Apr 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 | King Legacy, a wholly owned subsidiary of Pfizer | Drug | Class II | 11 |
| 30 Apr 2013 | CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: COOKIE: Flour,… | Carson's Country Market | Food | Class I | 2 |
| 26 Apr 2013 | Krinos TAHINI ground sesame seeds, 1) Net. Wt. 1 lb (454g) in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28500-3, 2) Net. Wt. 2 lb in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28510-2 and 3) Net. Wt. 40 lb (18 kg) in plastic tub packed 1 tub per case-UPC Code… (65041) | Krinos Foods, Inc. | Food | Class I | 1 |
| 26 Apr 2013 | Orville Redenbacher's Classic Kettle Korn, sweet and salty popcorn, ready-to-eat, packaged in 5-oz/plastic bags (Unit UPC code 027000523216) and 1.5-oz/plastic bags (Unit UPC code 027000523254). | Conagra Inc | Food | Class I | 1 |
| 25 Apr 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light… | Hologic, Inc. | Device | Class II | 2 |
| 25 Apr 2013 | Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. | Maple View Ice Cream | Food | Class I | 3 |
| 25 Apr 2013 | La Romanella Precooked Tri Color Cheese Tortellini, 2.5-lb bag (65063) | SMART AND FINAL STORES CORP | Food | Class II | 1 |
| 24 Apr 2013 | Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0. (65023) | Early Bird Foods & Co., LLC | Food | Class II | 1 |
| 22 Apr 2013 | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products | Device | Class II | 1 |
| 22 Apr 2013 | Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO.… | Legacy Pharmaceutical Packaging LLC | Drug | Class II | 1 |
| 22 Apr 2013 | Bean Sprouts: Keep Refrigerated: Ingredients: Mung Beans Net WT: 10 lbs (4.54 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. UPC 00000 20001 | Alfred Louie Inc | Food | Class I | 2 |
| 22 Apr 2013 | Snap! crisped rice in a rice-milk chocolatey coating, 1.75 oz, dairy-free, vegan, no trans fats, no hydrogenated oils, no cholesterol, nothing artificial. Distributed by Go Max Go Foods, LLC 57 Puye Road, Santa Fe, NM 87505. | Go Max Go Foods | Food | Class I | 7 |
| 19 Apr 2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85 | Novartis Consumer Health | Drug | Class III | 1 |
| 19 Apr 2013 | GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21. | Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 18 Apr 2013 | Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal… | Cook, Inc. | Device | Class I | 2 |
| 18 Apr 2013 | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. | Sandoz Incorporated | Drug | Class II | 1 |
| 17 Apr 2013 | TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Axium Healthcare Pharmacy dba Balanced Solutions Compounding | Drug | Class II | 26 |
| 16 Apr 2013 | Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286 | Wegmans Food Markets | Food | Class I | 1 |
| 15 Apr 2013 | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 15 Apr 2013 | FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to… | Abbott Diabetes Care, Inc. | Device | Class I | 1 |
| 15 Apr 2013 | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth. | Cypress Medical Products LLC | Device | Class II | 1 |
| 15 Apr 2013 | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.… | Bio-rad Laboratories, Inc. | Device | Class III | 1 |
| 15 Apr 2013 | Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution information on the label. A general… (64907) | Nexgen Pharma, Inc. | Food | Class III | 1 |
| 15 Apr 2013 | O Organics Black Bean Enchiladas 9 oz. (64917) | Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. | Food | Class I | 1 |
| 12 Apr 2013 | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 12 Apr 2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | Progressive Medical Inc | Device | Class II | 17 |
| 12 Apr 2013 | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. | Covidien LLC | Device | Class III | 2 |
| 12 Apr 2013 | Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8. | OPMX, LLC | Drug | Class II | 2 |
| 11 Apr 2013 | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 11 Apr 2013 | Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz (65069) | Winn-Dixie Logistics, Inc. | Food | Class II | 1 |
| 11 Apr 2013 | Organics Nature's Promise Organic Cranberry Juice Blend UPC 688267036163 - 64 FL OZ (2 QT) 1.89L Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 | Clement Pappas & Co., Inc. | Food | Class II | 18 |
| 11 Apr 2013 | Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6 (64897) | Wild Blue Yonder Foods/Waugh | Food | Class I | 1 |
| 10 Apr 2013 | Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor (64962) | Symmetry Medical/SSI | Device | Class II | 1 |
| 10 Apr 2013 | LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. | Boston Scientific CRM Corp | Device | Class II | 1 |
| 10 Apr 2013 | Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | FVS Holdings, Inc. dba. Green Valley Drugs | Drug | Class II | 78 |
| 9 Apr 2013 | Meijer Essential M with Real Strawberries, 12 oz. | Meijer Distribution, Inc | Food | Class II | 1 |
| 9 Apr 2013 | Cabrales Rojo Prieto Cheese, 1.9 kg or 4.1 lbs each wheel. 2 units per carton. (64877) | La Espanola Meats Inc | Food | Class II | 1 |
| 8 Apr 2013 | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. | Philips Healthcare Inc. | Device | Class II | 1 |
| 8 Apr 2013 | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. | Covidien LLC | Device | Class II | 2 |
| 8 Apr 2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. | Hospira Inc. | Drug | Class II | 1 |
| 8 Apr 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01 | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 6 Apr 2013 | Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6 | Paleteria Y Neveria La Rosita, LLC | Food | Class II | 13 |
| 5 Apr 2013 | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation… | Newport Medical Instruments Inc | Device | Class I | 1 |
| 5 Apr 2013 | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, (64800) | Medtox Diagnostics Inc | Device | Class II | 1 |
| 5 Apr 2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. | Glenmark Generics Inc., USA | Drug | Class III | 3 |
| 5 Apr 2013 | Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case | Royal Foods, Inc. | Food | Class III | 2 |
| 4 Apr 2013 | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone. (64988) | Medshape Solutions, INC. | Device | Class II | 1 |
| 4 Apr 2013 | Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 4 Apr 2013 | Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Apr 2013 | Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8. | Aaron Industries Inc | Drug | Class III | 1 |
| 3 Apr 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 2 Apr 2013 | Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small) (64827) | Centerville Pie Company, Inc. | Food | Class I | 1 |
| 1 Apr 2013 | cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 1 Apr 2013 | 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. | Encore Medical, Lp | Device | Class II | 1 |
| 1 Apr 2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01 | Lloyd Inc. of Iowa | Drug | Class II | 20 |
| 1 Apr 2013 | ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts. (64838) | Consumer Concepts, Inc. | Drug | Class I | 1 |
| 1 Apr 2013 | Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case (64822) | Planet Food | Food | Class III | 1 |
| 28 Mar 2013 | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. | Teleflex Medical | Device | Class II | 1 |
| 28 Mar 2013 | A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for… | Baxter Healthcare Corp. | Device | Class II | 4 |
| 28 Mar 2013 | Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being… | Smiths Medical ASD, Inc. | Device | Class II | 6 |
| 28 Mar 2013 | Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 28 Mar 2013 | MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand. | GE Healthcare, LLC | Device | Class II | 2 |
| 28 Mar 2013 | Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.. | Integra LifeSciences Corporation | Device | Class II | 21 |
| 28 Mar 2013 | Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244 (64722) | NuVision Pharmacy, Inc. | Drug | Class II | 1 |
| 28 Mar 2013 | all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters | All One, Inc. | Food | Class II | 2 |
| 28 Mar 2013 | Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 41322 37813 2; Product Code 37691 Net Wt.… | Rich Products Corp | Food | Class I | 4 |
| 27 Mar 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. | Individual firm, name withheld | Device | Class II | 20 |
| 27 Mar 2013 | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane. | Summit Medical, Inc. | Device | Class II | 1 |
| 27 Mar 2013 | RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. | Accuray Incorporated | Device | Class II | 1 |
| 26 Mar 2013 | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 26 Mar 2013 | MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply… | Owens & Minor Distribution, Inc. | Device | Class II | 1 |
| 26 Mar 2013 | Presource PBDS, Gyn Laparoscopy Kit, Circulator | Cardinal Health, Medical Products & Services | Device | Class I | 14 |
| 26 Mar 2013 | Adobo sin pimienta (Adobo without pepper) in 5 oz, 14 oz, and 32 oz | Lisy Corp. | Food | Class I | 5 |
| 25 Mar 2013 | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 25 Mar 2013 | Lam Sheng Kee, Frozen White Fish Ball - Shrimp Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002. UPC 6949682804640 | Win Luck Trading Inc | Food | Class I | 4 |
| 25 Mar 2013 | Bakehouse Granola, 12 oz, 340 g Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally (64772) | SIB, Inc. | Food | Class II | 1 |
| 22 Mar 2013 | ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 5 |
| 22 Mar 2013 | Island Mix, 12 oz. with best by date of 02/17/2014 (64909) | Nuts Are Good! Inc. | Food | Class II | 1 |
| 20 Mar 2013 | AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.… | Beckman Coulter Inc. | Device | Class II | 1 |
| 20 Mar 2013 | Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. | Heartland Gourmet, LLC | Food | Class I | 3 |
| 18 Mar 2013 | Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 18 Mar 2013 | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered… | Hospira Inc. | Device | Class I | 2 |
| 18 Mar 2013 | NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. | NxStage Medical, Inc. | Device | Class II | 1 |
| 18 Mar 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two… | Hospira Inc. | Device | Class I | 2 |
| 18 Mar 2013 | Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054 (64652) | Reckitt Benckiser Inc | Drug | Class III | 1 |
| 18 Mar 2013 | Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 16 Mar 2013 | "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015. (64963) | Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals | Drug | Class II | 1 |
| 15 Mar 2013 | Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion. | Vital Images, Inc. | Device | Class II | 1 |
| 15 Mar 2013 | Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between… | Insight Instruments, Inc. | Device | Class II | 1 |
| 15 Mar 2013 | Dried Mango (3.5oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578. | S & M International Inc | Food | Class II | 5 |
| 15 Mar 2013 | Grippo's Potato Chips, 1oz, 1 1/8oz , 1¿oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61701 5 Product Quantity Distributed: 1,410cs/60/1oz bags; 860cs/48/1 1/8oz bags;… | Grippo Potato Chip Co., Inc. | Food | Class II | 6 |
| 14 Mar 2013 | VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 13 Mar 2013 | SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension. (64718) | Separation Technology, Inc. | Device | Class II | 1 |
| 13 Mar 2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). | Masimo Corporation | Device | Class II | 1 |
| 12 Mar 2013 | Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc.,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 12 Mar 2013 | Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01, | L. Perrigo Co. | Drug | Class III | 1 |
| 11 Mar 2013 | BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms. | Becton Dickinson & Co. | Device | Class II | 3 |
| 11 Mar 2013 | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1. | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 8 Mar 2013 | APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree 184016-10 Anterior Psoas Lumbar 18 x 40… (64578) | Spinal Solutions, LLC | Device | Class II | 1 |
| 7 Mar 2013 | Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The… | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 1 |
| 7 Mar 2013 | Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod 5.5 x 90mm BGR0100 Straight Rod 5.5 x 100mm… (64584) | Orthopedic Alliance LLC | Device | Class II | 1 |
| 7 Mar 2013 | Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net | Ozone Confection & Bakers Supply Co. | Food | Class II | 3 |
| 6 Mar 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 Mar 2013 | The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative… | Alere San Diego, Inc. | Device | Class II | 1 |
| 4 Mar 2013 | NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice… | Philips And Neusoft Medical Systems Co., Ltd. | Device | Class II | 2 |
| 4 Mar 2013 | Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato, Ca 94949. Product of USA (64871) | Juice Bar Solutions | Food | Class III | 1 |
| 1 Mar 2013 | Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 1 Mar 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat… | American Medical Systems, Inc. | Device | Class II | 2 |
| 1 Mar 2013 | Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr. (64923) | Jans Enterprises Corp. dba WIRA Corp. | Food | Class II | 1 |
| 27 Feb 2013 | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. (64508) | Sirtex Medical Limited | Device | Class III | 1 |
| 26 Feb 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 | 4 |
| 26 Feb 2013 | Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 25 Feb 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Nova Biomedical Corporation | Device | Class II | 2 |
| 22 Feb 2013 | Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 15 Feb 2013 | Molift Smart 150 | Individual firm, name withheld | Device | Class II | 2 |
| 15 Feb 2013 | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation. (64618) | Unimed Surgical Products, Inc. | Device | Class II | 1 |
| 15 Feb 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 | Warner Chilcott Company LLC | Drug | Class III | 3 |
| 11 Feb 2013 | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90 | Jubilant Cadista Pharmaceuticals Inc. | Drug | Class II | 1 |
| 8 Feb 2013 | BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks,… | Becton Dickinson & Co. | Device | Class II | 1 |
| 8 Feb 2013 | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET),… | Individual firm, name withheld | Device | Class I | 2 |
| 8 Feb 2013 | Dried mushrooms sold under the following brand names: 1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 1/2 cup (7g… (64315) | DZH Import & Export Inc. | Food | Class I | 1 |
| 5 Feb 2013 | BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website:… | Buffalo Trace Distillery | Food | Class I | 5 |
| 4 Feb 2013 | Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA;… (64634) | Carib Import & Export, Inc. | Drug | Class II | 1 |
| 31 Jan 2013 | Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3. | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 31 Jan 2013 | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1. | Gilead Sciences, Inc. | Drug | Class I | 1 |
| 30 Jan 2013 | QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook. | QIAGEN Gaithersburg, Inc. | Device | Class II | 2 |
| 25 Jan 2013 | Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 21 Jan 2013 | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use. | Alere San Diego, Inc. | Device | Class III | 1 |
| 9 Jan 2013 | Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Dec 2012 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | Heartware Inc | Device | Class II | 1 |
| 22 Dec 2012 | Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9. (64190) | D& S Herbals, LLC | Drug | Class I | 1 |
| 21 Dec 2012 | 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye… | Johnson & Johnson Vision Care, Inc. | Device | Class II | 2 |
| 17 Dec 2012 | libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253. | Performance Plus Marketing, Inc. | Drug | Class I | 7 |
| 10 Dec 2012 | WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico. (63867) | Brower Enterprises Inc | Drug | Class I | 1 |
| 4 Dec 2012 | Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV. | Green Valley Drugs | Drug | Class I | 2 |
| 1 Nov 2012 | VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum. | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 8 Oct 2012 | Goldenbrook Farms Peanut Butter Bash Ice Cream, 1/2 gallon carton with UPC code 0009282530538 (63418) | Brookshire Grocery Company Manufacturing | Food | Class I | 1 |
| 1 Oct 2012 | Chicken Spring Rolls Dist. by Whole Foods Market, UPC 225757203997 | Whole Foods Market | Food | Class I | 2 |
| 18 Sep 2012 | CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. | Trophy Sas | Device | Class II | 4 |
| 18 Sep 2012 | Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series. | Iris Diagnostics | Device | Class II | 1 |
| 28 Aug 2012 | Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 | Hospira Inc. | Drug | Class II | 2 |
| 23 Aug 2012 | Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351 | Evol Nutrition | Drug | Class I | 2 |
| 16 Aug 2012 | KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview. | Karl Storz Endoscopy America Inc | Device | Class II | 1 |
| 10 Aug 2012 | MyRay RXDC dental unit x-ray unit (65036) | CEFLA DENTAL GROUP | Device | Class II | 1 |
| 3 Jul 2012 | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. (65018) | Chicago X-Ray Systems, Inc. | Device | Class II | 1 |
| 25 Jun 2012 | Hokkai Frozen Half Shell Oyster, 144 pcs/case. | Hong Chang Corporation | Food | Class II | 4 |
| 8 Jun 2012 | GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. | GE Healthcare, LLC | Device | Class II | 3 |
| 18 May 2012 | a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule… (61900) | InSo-Independent Contractor for West Coast Nutritionals,LTD | Drug | Class I | 1 |
| 7 Mar 2012 | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 20 Dec 2011 | GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. | GE Healthcare, LLC | Device | Class II | 1 |
| 6 Oct 2011 | GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence,… | GE Healthcare, LLC | Device | Class II | 1 |
| 25 Jul 2011 | GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission. | GE Healthcare, LLC | Device | Class II | 1 |
| 21 Jul 2011 | SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures (64621) | Discus Dental LLC | Device | Class II | 1 |
| 31 May 2011 | Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation… | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 23 May 2011 | Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD. | Physicians Total Care, Inc. | Drug | Class III | 1 |
| 8 Feb 2011 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146. | Physicians Total Care, Inc. | Drug | Class III | 1 |
| 29 Jul 2010 | TD-Synergy. Laboratory Information System. (56447) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Nov 2009 | Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus… | Olympus America Inc. | Device | Class II | 1 |
| 1 Jun 2009 | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | Karl Storz Endoscopy America Inc | Device | Class II | 12 |
| 17 Apr 2009 | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements, Inc | Device | Class III | 21 |
| 6 Apr 2009 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement… (64594) | Stellate Systems | Device | Class II | 1 |