| 10 Jun 2015 | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31. | AstraZeneca Pharmaceuticals LP | Drug | Class II | 1 |
| 3 Jun 2015 | Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03 | Baxter Healthcare Corp | Drug | Class II | 1 |
| 2 Jun 2015 | CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier,… | Boston Scientific Corporation | Device | Class II | 1 |
| 1 Jun 2015 | Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. | Elekta, Inc. | Device | Class II | 1 |
| 29 May 2015 | AGFA DX-D 100 is a mobile digital radiography x-ray system | AGFA Healthcare Corp. | Device | Class II | 1 |
| 29 May 2015 | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device… (71405) | Mortara Instrument, Inc | Device | Class II | 1 |
| 28 May 2015 | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational… | Synthes, Inc. | Device | Class II | 1 |
| 28 May 2015 | Byrds Famous Cookies, Benne Bits, Net Wt. 6 oz. tins, UPC: 0-74882904651-8, Byrd Cookie Company, P.O. Box 1308, Savannah, GA 31416. | Byrd Cookie Co | Food | Class II | 2 |
| 27 May 2015 | Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 26 May 2015 | CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings. | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 22 May 2015 | Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India | Individual firm, name withheld | Drug | Class II | 2 |
| 22 May 2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via… | Novartis Pharmaceuticals Corp. | Drug | Class III | 2 |
| 22 May 2015 | Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02 | Blenheim Pharmacal, Inc. | Drug | Class II | 2 |
| 21 May 2015 | Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. | Elekta, Inc. | Device | Class II | 1 |
| 21 May 2015 | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 21 May 2015 | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433 | Medtech Products, Inc. | Drug | Class II | 1 |
| 20 May 2015 | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 | CooperSurgical, Inc. | Device | Class II | 1 |
| 20 May 2015 | Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7. (71218) | Mylan Lab Inc | Drug | Class II | 1 |
| 20 May 2015 | Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40, 41/50, 51/60, 61/70, 71/80, 81/90, Large Pcs, Medium Pcs.) I.Q.F P&D Round T/ON Net Weight 3 Lbs. (48 oz.) in plain bag and master; 18 lbs. per case, 6 bags per case. Wild Caught Gulf Shrimp Packed For: Gerald Pockrus;… (71301) | Texas Pack, Inc. | Food | Class II | 1 |
| 19 May 2015 | Fresh Driscoll Strawberries, 8 x 16 oz. clamshell, 4 x 32 oz. clamshell. Keep refrigerated Driscoll's Strawberries, Watsonville, CA (71303) | Individual firm, name withheld | Food | Class III | 1 |
| 18 May 2015 | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature… (71279) | Coreva Health Science LLC | Device | Class II | 1 |
| 18 May 2015 | M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular… | Zimmer, Inc. | Device | Class I | 1 |
| 18 May 2015 | ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 18 May 2015 | ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse | Orthofix, Inc | Device | Class II | 1 |
| 18 May 2015 | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS | CooperSurgical, Inc. | Device | Class II | 1 |
| 18 May 2015 | CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Advanced Physician Solutions, Inc. | Drug | Class II | 18 |
| 18 May 2015 | Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 REFRIGERATE AFTER OPENING .0 93662 45252 2 | Michael Zakany LLC | Food | Class II | 1 |
| 15 May 2015 | Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 May 2015 | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis… | Philips Ultrasound, Inc. | Device | Class II | 1 |
| 15 May 2015 | MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04 | Mallinckrodt, Inc. | Drug | Class II | 1 |
| 15 May 2015 | Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Montana Compounding Pharmacy | Drug | Class II | 12 |
| 14 May 2015 | The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac. (71365) | BIOMET FRANCE S.A.R.L. | Device | Class II | 1 |
| 13 May 2015 | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for… | Synthes, Inc. | Device | Class II | 1 |
| 13 May 2015 | Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction) | Advanced Back Technologies, Inc. | Device | Class II | 2 |
| 13 May 2015 | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone. | Synthes, Inc. | Device | Class II | 1 |
| 13 May 2015 | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. | CareFusion 303, Inc. | Device | Class II | 1 |
| 13 May 2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25. | West-Ward Pharmaceutical Corp. | Drug | Class III | 1 |
| 12 May 2015 | T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation (71247) | Vidacare Corporation | Device | Class II | 1 |
| 12 May 2015 | Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon… | Allegiant Health | Drug | Class II | 1 |
| 11 May 2015 | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of… | Advanced Sterilization Products | Device | Class II | 2 |
| 11 May 2015 | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use. | Abbott Laboratories | Device | Class II | 1 |
| 11 May 2015 | Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 May 2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 8 May 2015 | RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 8 May 2015 | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO | Gyrus Acmi, Incorporated | Device | Class II | 2 |
| 8 May 2015 | 250cc White Plastic Container containing 120 capsules, labeled Natural Creations New Zealand Colostrum, Colostrum Supplement, MFG. FOR: Natural Creations, Woodbine, IA 51579, 712-647-1600 (71245) | Natural Creations Inc | Food | Class II | 1 |
| 8 May 2015 | 1-lb, 2-lb and 10-lb bags of Soybean Sprouts in clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated | Good Seed, Inc. | Food | Class I | 2 |
| 7 May 2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 6 May 2015 | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class III | 1 |
| 6 May 2015 | enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 6 May 2015 | syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 6 May 2015 | R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due… | Smith & Nephew, Inc. | Device | Class II | 5 |
| 6 May 2015 | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded… | Biocare Medical, LLC | Device | Class III | 1 |
| 6 May 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India | Individual firm, name withheld | Drug | Class III | 4 |
| 6 May 2015 | Golden Krust SOYA PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN | Golden Krust Caribbean Bakery, Inc. | Food | Class I | 2 |
| 5 May 2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | ResMed Ltd. | Device | Class II | 1 |
| 5 May 2015 | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 5 May 2015 | Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 5 May 2015 | Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 5 May 2015 | evolution FRESH brand Fresh Berries & Honey, Nonfat Greek Yogurt with Strawberries, Blueberries, Pure Honey, & Granola; NET WT 6.5 OZ/184 g; Perishable Keep Refrigerated; SKU 11048364; Made Exclusively For: Evolution Fresh, Inc. 2401 Utah Avenue South Seattle, WA 98134 USA. The product is packaged in clear plastic… (71210) | Flying Food Group - LAW | Food | Class II | 1 |
| 4 May 2015 | Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously. | Smiths Medical Asd Inc | Device | Class II | 1 |
| 4 May 2015 | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions. | Remel Inc | Device | Class II | 1 |
| 4 May 2015 | Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 4 May 2015 | Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC… | Ohm Laboratories, Inc. | Drug | Class III | 1 |
| 4 May 2015 | Coconut Water with Pineapple, 12 bottles/case, 12 oz (355 mL) | Creative Food Concepts | Food | Class II | 2 |
| 2 May 2015 | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The… (71191) | Synovis Surgical Innovations, Inc. | Device | Class I | 1 |
| 1 May 2015 | Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality | Biomet, Inc. | Device | Class II | 1 |
| 1 May 2015 | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 1 May 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits | Beaver-Visitec International Inc. | Device | Class II | 5 |
| 1 May 2015 | Kroger Raw #4 Macadamia Nut, Dist. by the Kroger Company Cincinnati, Ohio 2 04192 50867 6 | The Kroger Co | Food | Class I | 1 |
| 1 May 2015 | Salted Caramel Premium Puffed Corn, Cosmo Creations brand, Nitrogen filled, 3-layer laminate packaging, Net weight 14 oz., UPC 8 51710 00141 8. (71165) | 4 Him Food Group LLC | Food | Class II | 1 |
| 1 May 2015 | Sun Rich Apple Slices with Caramel Dip, Parfait Cup, 6 x 6 oz. | Sun Rich Fresh Foods Inc | Food | Class I | 5 |
| 30 Apr 2015 | PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument | Zimmer, Inc. | Device | Class II | 1 |
| 30 Apr 2015 | I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system… | Neuro Kinetics, Inc. | Device | Class II | 1 |
| 30 Apr 2015 | Oregano, Mediterranean ground, stock code 03355, packaged in 0.2 lb., .75 lb., 0.8 lb., 1 lb., 4 lbs., 10 lbs., 15 lbs., 25 lbs., or 50 lbs. container. The UPC for 50 lbs. container is 0 23605 03355 6. | Regency Group, Inc., The | Food | Class II | 11 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. | HeartWare Inc | Device | Class I | 1 |
| 29 Apr 2015 | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device. | Zimmer, Inc. | Device | Class II | 1 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. | HeartWare Inc | Device | Class II | 1 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure. | HeartWare Inc | Device | Class I | 1 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. | HeartWare Inc | Device | Class I | 1 |
| 28 Apr 2015 | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove. | Alcon Research, Ltd. | Device | Class II | 1 |
| 28 Apr 2015 | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. . | Acclarent, Inc. | Device | Class III | 1 |
| 28 Apr 2015 | KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20. | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 28 Apr 2015 | PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029. | SCA Pharmaceuticals | Drug | Class II | 1 |
| 27 Apr 2015 | 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe. | MRP, LLC dba AMUSA | Device | Class II | 1 |
| 27 Apr 2015 | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 27 Apr 2015 | Channel Island Old Fashioned Smoked Atlantic Salmon Keep Refrigerated Exclusively Distributed By Gourmet Foods, Rancho Dominguez, CA 90221 The product is ROP and is either kept refrigerated or frozen. | The Santa Barbara Smokehouse, Inc. | Food | Class I | 5 |
| 24 Apr 2015 | EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 24 Apr 2015 | D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and… | GE Healthcare | Device | Class II | 1 |
| 24 Apr 2015 | Mother's Milk was labeled as "Mature milk". This is breast milk and was donated from nursing mothers. Product is packaged in glass bottle, 4 oz. The logo of Mother's Milk Bank is observed on a label. All milk was shipped frozen. (71259) | Mothers' Milk Bank of Montana | Food | Class III | 1 |
| 23 Apr 2015 | Seasoning Fish Filet Ingredients: Mixed Fish, Sugar, Salt, Monosodium Glutamate, Sorbic Acid Bulk cases with 12kg of fish fillets which are packaged in clear plastic. The label does not declare the type of fish, other ingredients in the product, or nutrition facts. (71083) | Roxy Trading Inc | Food | Class II | 1 |
| 22 Apr 2015 | AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. | Roche Diabetes Care, Inc. | Device | Class II | 2 |
| 22 Apr 2015 | Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. | Vilex In Tennessee Inc | Device | Class II | 3 |
| 22 Apr 2015 | Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs… (71059) | Alere Scarborough, Inc. dba Binax, Inc. | Device | Class II | 1 |
| 22 Apr 2015 | Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. | Biomet, Inc. | Device | Class II | 1 |
| 21 Apr 2015 | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 | DePuy Spine, Inc. | Device | Class II | 1 |
| 20 Apr 2015 | Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled. (71112) | Compass Health Brands | Device | Class II | 1 |
| 20 Apr 2015 | Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 20 Apr 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 20 Apr 2015 | Gromex Camaron Molido (Ground Shrimp), Net Wt. 2 oz., packaged in a clear bag, Mexican Products, Importers & Distributors, UPC 690912620108 (71126) | Gromex Inc. | Food | Class III | 1 |
| 19 Apr 2015 | Tibial Alignment Guide; Orthopedic Stereotaxic Instrument; (71202) | Individual firm, name withheld | Device | Class II | 1 |
| 17 Apr 2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01. | Valeant Pharmaceuticals North America LLC | Drug | Class II | 1 |
| 17 Apr 2015 | Guayaki Brand Yerba Mate - Revel Berry; 16 oz aluminum can, Best By 12SEP16. UPC 6 32432 73777 5 Guayaki Yerba Mate is a high energy infusion made from the leaves of the celebrated South American mate tree. Guayaki S.R. P. Sebastopol, CA 95472 Certified Organic by CCOF Certified Fair Trade by IMO (71069) | Guayaki S.R.P., Inc. | Food | Class II | 1 |
| 16 Apr 2015 | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners. | Biomet, Inc. | Device | Class III | 4 |
| 15 Apr 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC… | Sandoz, Inc | Drug | Class III | 1 |
| 15 Apr 2015 | Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry), Distributed by Reaction Nutrition, Carnegie, PA | Reaction Nutrition LLC | Food | Class II | 13 |
| 14 Apr 2015 | KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135). | Halyard Health, Inc | Device | Class II | 1 |
| 14 Apr 2015 | Pasta salad sold under the brand name CHEF'S EXPRESS CALIFORNIA PASTA SALAD, UPC 2 10612 30070 6. Product is sold by weight through firm's Deli / Chef's Express department in plastic containers. Variable weight item. The responsible name on the label is Schnucks St. Louis, MO. | Schnucks Markets Corporate Office | Food | Class I | 1 |
| 13 Apr 2015 | Brilliance iCT Computed Tomography X-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 13 Apr 2015 | Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | United Surgical Associates | Device | Class II | 3 |
| 13 Apr 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 13 Apr 2015 | Garber's Old Fashioned Ice cream, Birthday Cake Flavored 1.75 quarts, packed in a shrink wrap of 3. #1 lot of 211/ 3 pk produced on 12/12/13 expires on 12/12/14 #2 lot of 451/3 pk produced on 3/31/14 expires 3/31/15 #3 lot of 454/3 pk produced on 11/5 14 expires on 11/5/15 1116 (three packs) = 3348 singles (71221) | Garber Ice Cream Company Inc | Food | Class I | 1 |
| 12 Apr 2015 | Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy. (71168) | Stroheckers Inc Pharmacy | Drug | Class I | 1 |
| 10 Apr 2015 | Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II… (71047) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Apr 2015 | UBERVITA LOSE WEIGHT FAST W700 THERMOGENIC HYPER-METABOLIZER DIETARY SUPPLEMENT. The product has an outer box which contains a labeled bottle. This is a bright red box with gold and chrome foil. Bottle inside is black and red in color. UPC 7 00115 35277 2 (70978) | Uber Vita LLC | Food | Class II | 1 |
| 9 Apr 2015 | Desiccated Coconut Distributed by: Phildesco , Inc. Somerset, New Jersey 08873 USA (71146) | Phildesco Inc. | Food | Class I | 1 |
| 7 Apr 2015 | Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16 | Akorn, Inc. | Drug | Class II | 2 |
| 6 Apr 2015 | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 6 Apr 2015 | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing. | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 3 Apr 2015 | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | Carefusion 211 Inc dba Carefusion | Device | Class I | 1 |
| 2 Apr 2015 | FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations. | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 1 |
| 2 Apr 2015 | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25 | Boehringer Ingelheim Roxane Inc | Drug | Class II | 1 |
| 31 Mar 2015 | BRAN Whole Foods Market Muffin Bran 6Pk packaged in clear plastic "clam shell" containers, NET WT. 12 oz., PLU 24857800499 Dist. by Whole Foods Market Austin, TX 78703 | Whole Food Market | Food | Class I | 1 |
| 25 Mar 2015 | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Mar 2015 | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. | Nidek Inc | Device | Class II | 1 |
| 22 Mar 2015 | Amy's Vegetable Lasagna, 9.5 oz (269 g) 12 boxes per case. UPC 0 42272 00032 6 - US Distribution: UPC 0-42272-90032-9 - Canadian distribution Vegetable Lasagna 8 pack - 9.5 oz, (269g) UPC: 0-42272-00032-6 - US distribution Family Size, 28 oz. (794 g), 8 boxes per case UPC 0-42272-00965-7 - US distribution Club size,… | Amys Kitchen Inc | Food | Class II | 13 |
| 21 Mar 2015 | Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 20 Mar 2015 | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift. | Hill-Rom, Inc. | Device | Class II | 1 |
| 20 Mar 2015 | Apricot Filled Cookie OTC Sell By: (all dates up to) 3/23/2015 Net WT. 1 OZ Contains:Egg, Wheat, Soy ; Cookies affected are only sold direct from bakery counter and packaged at time per customer request and packed either in clam shell plastic or wax paper. ; Net Weight on label may differ depending on number of… | Giant Eagle, Inc. | Food | Class I | 2 |
| 19 Mar 2015 | SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is… | Biosense Webster, Inc. | Device | Class II | 1 |
| 19 Mar 2015 | Hacizade Pismaniye Pashmak (Cotton Candy with Rose), Net Wt. 250-g (8.80-oz.), UPC 8697407913372 | Turkana Food Inc. | Food | Class III | 1 |
| 17 Mar 2015 | Citrus Organic Vinaigrette Dressing packaged in a plastic gallon jar with a white twist cap. Sold under the Conway Dressing brand name Storage instructions: must refrigerate. | Conway Import Co | Food | Class I | 2 |
| 16 Mar 2015 | MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 11 |
| 16 Mar 2015 | Frontier Natural Products Co-Op Garlic Powder, Certified Organic, Non-Irradiated with responsible firm name Frontier Norway, IA packaged in the following configurations: (1) Foil packet labeled Powdered Garlic Allium sativum, Net 453 g 16 oz. UPC code 0 89836 00352 2; (2) Glass bottle with green plastic cap labeled… | Frontier Natural Products Co-op | Food | Class I | 25 |
| 12 Mar 2015 | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 11 Mar 2015 | Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 11 Mar 2015 | LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08. | Hospira Inc. | Drug | Class I | 1 |
| 9 Mar 2015 | Rugby Poly Vitamin Liquid, 50ml | Pharmatech Llc | Food | Class II | 2 |
| 6 Mar 2015 | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 35 |
| 5 Mar 2015 | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and… | Codman & Shurtleff, Inc. | Device | Class II | 1 |
| 5 Mar 2015 | Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 2 |
| 5 Mar 2015 | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. | Siemens Medical Solutions Diagnostics | Device | Class II | 6 |
| 4 Mar 2015 | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery. | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 2 Mar 2015 | Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11 | American Health Packaging | Drug | Class II | 1 |
| 27 Feb 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. | Volk Optical Inc | Device | Class III | 1 |
| 25 Feb 2015 | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Amerx Health Care Corp. | Device | Class II | 1 |
| 20 Feb 2015 | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. (70672) | Optimedica Corporation | Device | Class II | 1 |
| 9 Feb 2015 | T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe. | MRP, LLC dba AMUSA | Device | Class II | 1 |
| 12 Jan 2015 | Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3 | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 24 Dec 2014 | Roche Brothers Berry Nutty Mix trail mix packed in 9 oz. and 20 oz. clear plastic containers | Northhampton Peanut Company | Food | Class II | 2 |
| 21 Nov 2014 | BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages… | Becton Dickinson & Co. | Device | Class II | 2 |
| 7 Nov 2014 | BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic. | Becton Dickinson & Co. | Device | Class II | 1 |
| 17 Oct 2014 | Bizcocho de Queso (Cheese Cake) 10oz | AYAA Popcorn Manufacturing Corp. | Food | Class I | 6 |
| 1 Jul 2014 | Kratom (Kr8om) Maeng Da Thai Pure Alkaloid Suspension Oil in 150 mg, | Nuevotanicals | Food | Class II | 10 |
| 22 May 2014 | GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 8 Mar 2014 | Neusoft NeuViz 64 Multi-slice CT Scanner System (71306) | Neusoft Medical System Co | Device | Class II | 1 |
| 20 Sep 2013 | MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. (71296) | Medrad Inc dba Bayer R&I | Device | Class II | 1 |