| 12 Aug 2016 | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses… | Novarad Corporation | Device | Class II | 1 |
| 12 Aug 2016 | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac… | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 2 |
| 4 Aug 2016 | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 3 Aug 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves | LeMaitre Vascular, Inc. | Device | Class II | 3 |
| 3 Aug 2016 | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve. | Medtronic Cardiovascular Surgery-the Heart Valve Division | Device | Class II | 1 |
| 3 Aug 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS. | Golden State Medical Supply Inc. | Drug | Class II | 2 |
| 2 Aug 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82 | Actavis Inc | Drug | Class III | 2 |
| 1 Aug 2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109 | Isomeric Pharmacy Solution, LLC | Drug | Class II | 1 |
| 1 Aug 2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901 | Spectrum Laboratory Products, Inc. | Drug | Class II | 1 |
| 29 Jul 2016 | OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub. | SM Fish Corp. | Food | Class I | 14 |
| 28 Jul 2016 | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class III | 1 |
| 27 Jul 2016 | CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. | INNOKAS MEDICAL OY | Device | Class II | 1 |
| 27 Jul 2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60. | Akorn, Inc. | Drug | Class III | 1 |
| 26 Jul 2016 | IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 26 Jul 2016 | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement. | Encore Medical, Lp | Device | Class II | 1 |
| 26 Jul 2016 | la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box. Event 74791 | La Torre Foods Usa, Inc. | Food | Class II | 1 |
| 25 Jul 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and… | Tecan US, Inc. | Device | Class II | 7 |
| 22 Jul 2016 | OEC UroView 2800, fluoroscopic x-ray system | GE OEC Medical Systems, Inc | Device | Class II | 2 |
| 21 Jul 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 20 Jul 2016 | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses. | OraSure Technologies, Inc. | Device | Class I | 1 |
| 20 Jul 2016 | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is… | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 20 Jul 2016 | Brilliance 64 CT Model number 728231 Product Usage: 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 | 7 |
| 20 Jul 2016 | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 | Integra LifeSciences Corp. | Device | Class II | 2 |
| 19 Jul 2016 | TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 Event 74801 | Novus Scientific Ab | Device | Class II | 1 |
| 19 Jul 2016 | MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038. | Philips Electronics North America Corporation | Device | Class II | 3 |
| 19 Jul 2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 2 |
| 19 Jul 2016 | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded… | Talon Compounding Pharmacy | Drug | Class II | 2 |
| 19 Jul 2016 | Agave Dream Cappuccino Ice Cream Pint UPC code: 899349002048 Event 74747 | Name withheld | Food | Class I | 1 |
| 18 Jul 2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization | Cepheid | Device | Class II | 1 |
| 18 Jul 2016 | Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is… | Medtronic Navigation, Inc. | Device | Class II | 7 |
| 18 Jul 2016 | BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. | Bovie Medical Corporation | Device | Class II | 4 |
| 18 Jul 2016 | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct… | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 18 Jul 2016 | RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R, | Medtronic Sofamor Danek USA Inc | Device | Class II | 8 |
| 15 Jul 2016 | MOSAIQ Oncology Information System | Elekta, Inc. | Device | Class II | 1 |
| 15 Jul 2016 | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. Event 74724 | Topcon Medical Laser Systems, Inc | Device | Class II | 1 |
| 15 Jul 2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08. | Teva North America | Drug | Class III | 1 |
| 15 Jul 2016 | Domino PURE CANE LARGE GRAIN GRANULATED SUGAR, NET WT 50 LB (22.67 kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705 | Domino Foods, Inc. | Food | Class II | 1 |
| 14 Jul 2016 | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 14 Jul 2016 | Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510 | Straumann Manufacturing, Inc. | Device | Class II | 2 |
| 14 Jul 2016 | STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General,… | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 13 Jul 2016 | SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 13 Jul 2016 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 13 Jul 2016 | 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional… Event 74599 | AccessClosure, Inc., A Cardinal Health Company | Device | Class II | 1 |
| 12 Jul 2016 | Quattro Air FFM MED – AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators Event 74736 | Resmed Corporation | Device | Class II | 1 |
| 11 Jul 2016 | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio 2 Monitor and INRatio 2 PT/INR test strip, is used for quantitative… | Alere San Diego, Inc. | Device | Class I | 9 |
| 11 Jul 2016 | Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress. Event 74737 | American National Mfg Inc | Device | Class II | 1 |
| 11 Jul 2016 | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam. | Ivoclar Vivadent, Inc. | Device | Class II | 1 |
| 11 Jul 2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09 | Actavis Inc | Drug | Class II | 1 |
| 11 Jul 2016 | Golden Dipt Jalapeño Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690. | Kerry, Inc | Food | Class I | 2 |
| 8 Jul 2016 | NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from… | BioMerieux SA | Device | Class I | 1 |
| 8 Jul 2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | Medtronic | Device | Class II | 25 |
| 8 Jul 2016 | Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers. Made in a facility that processes Milk and Soy. Distributed by: Snack Factory, PO Box 6917, Hanover, PA 17331 Sold in the following sizes and UPC codes: 12 ct / 116 oz. Net Wt 26 oz (l lb 10 oz.) 737g, UPC 49508-00692, Net. Wt. 30 oz. (1 lb. 14… | Baptista's Bakery, Inc | Food | Class II | 1 |
| 8 Jul 2016 | 100% Organic Spelt Grain, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container. | Montana Flour & Grains, Inc | Food | Class II | 3 |
| 7 Jul 2016 | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 7 Jul 2016 | Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94. Event 74725 | Medicap Pharmacy | Drug | Class II | 1 |
| 6 Jul 2016 | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments. | Dako Denmark A/S | Device | Class II | 1 |
| 6 Jul 2016 | Bard TruGuide Disposable Coaxial Biopsy Needle – Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 6 Jul 2016 | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 6 Jul 2016 | Tortilla Crusted Crumb is a breading system. Product Item Key N21997-B. It composed of flour and other food grade ingredients. Product is bagged in 25 lbs. multiwalled polylined paper bags. Event 74638 | Hydroblend Inc | Food | Class I | 1 |
| 5 Jul 2016 | RePlant Angled Abutment Part Number 6050-52-60 | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 5 Jul 2016 | Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous,… | Siemens Healthcare Diagnostics Inc | Device | Class III | 1 |
| 5 Jul 2016 | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000… Event 74600 | Branan Medical Corporation | Device | Class III | 1 |
| 5 Jul 2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914. Event 74605 | Let's Talk Health, Inc. | Drug | Class II | 1 |
| 5 Jul 2016 | Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes. | Newly Weds Foods Inc | Food | Class I | 1 |
| 5 Jul 2016 | Label reads in part as: "Maga***BACALAITOS CODFISH FRITTER MIX***Peso Neto/Net Weight 4.5oz (128gr)***Productos La Finca Inc.***Zona Ind. Machuchal Ave. Quilinchini #61 Sabana Grande, PR 00637" | Productos La Finca, Inc. | Food | Class II | 1 |
| 4 Jul 2016 | Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width… | Zimmer Surgical Inc | Device | Class II | 7 |
| 1 Jul 2016 | DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access. | Carefusion 2200 Inc | Device | Class I | 1 |
| 1 Jul 2016 | Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 1 Jul 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It… | Nidek Inc | Device | Class II | 1 |
| 1 Jul 2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. | Sunrise Medical (US) LLC | Device | Class II | 1 |
| 1 Jul 2016 | Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. | Mentor Texas, LP. | Device | Class II | 1 |
| 1 Jul 2016 | 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 &… | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 1 Jul 2016 | 120 V Neptune 3 Rover, Model Number: 0703-001-000 | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 1 Jul 2016 | Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Jul 2016 | Cumberland Farms Farmhouse Premium Chocolate Treats - Sea Salt Carmel Delights, 3 oz. bag Event 74586 | New American Food Products, LLC. | Food | Class I | 1 |
| 30 Jun 2016 | Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction… | Zimmer Gmbh | Device | Class II | 1 |
| 30 Jun 2016 | AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. | Vision RT Ltd | Device | Class II | 2 |
| 30 Jun 2016 | PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. | MicroPort Orthopedics Inc. | Device | Class II | 1 |
| 30 Jun 2016 | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients. | C.R. Bard, Inc. | Device | Class III | 1 |
| 30 Jun 2016 | Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. | Zimmer Biomet Spine, Inc | Device | Class II | 2 |
| 30 Jun 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30 | Actavis Inc | Drug | Class II | 1 |
| 30 Jun 2016 | Label reads in part as: "EL ISLE O***SOFRITO GOURMET CON SAZON Y ACHIOTE***PESO NETO/NET WT. ***Keep Refrigerated***Marlin Distributors P.O. Box 8763 Bayamon, PR 00960***HECHO EN PUERTO RICO" Product presentations: 12oz and 32oz Event 74546 | AC Culinary Group LLC | Food | Class II | 1 |
| 30 Jun 2016 | Sundae Shoppe Novelty Ice Cream Dipped "Variety"cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962 Event 74597 | Mister Cookie Face Corporation | Food | Class II | 1 |
| 30 Jun 2016 | Raw Refrigerated Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated cardboard cases, Southern Valley Produce Lot 16300705. (The product was either distributed in original container or were repackaged). Event 74589 | Maglio & Co Ready Fresh | Food | Class I | 1 |
| 29 Jun 2016 | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) | TYRX Inc. | Device | Class II | 3 |
| 29 Jun 2016 | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device | C.R. Bard, Inc. | Device | Class III | 1 |
| 28 Jun 2016 | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and… | B-K Medical A/S | Device | Class II | 1 |
| 28 Jun 2016 | Spirit Plus Bed, A-C Powered Hospital Bed | CHG Hospital Beds Inc | Device | Class II | 2 |
| 28 Jun 2016 | Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 27 Jun 2016 | TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems. | Zimmer Gmbh | Device | Class II | 4 |
| 24 Jun 2016 | Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum… Event 74533 | Danville Materials, Inc. | Device | Class II | 1 |
| 24 Jun 2016 | Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the… Event 74529 | Name withheld | Device | Class II | 1 |
| 24 Jun 2016 | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 24 Jun 2016 | Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174;… | Cook Inc. | Device | Class I | 1 |
| 24 Jun 2016 | Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76 | Teva North America | Drug | Class II | 1 |
| 23 Jun 2016 | Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 23 Jun 2016 | AUTOCOMP6 XPS High Speed Compounder REF 58810 | The Metrix Company | Device | Class II | 8 |
| 23 Jun 2016 | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to… | Edan Diagnostics | Device | Class II | 1 |
| 23 Jun 2016 | Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Jun 2016 | Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Jun 2016 | DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the… Event 74552 | Name withheld | Device | Class II | 1 |
| 23 Jun 2016 | Michael's Naturopathic Programs Cholesterol Metabolism Factors 270 count, 180 count, and 90 count tablets packaged in plastic bottles Event 74517 | Inner Health Group, Inc dba Michael's Naturopathic Programs | Food | Class I | 1 |
| 23 Jun 2016 | Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA UPC 019320016769 | Mondelez International | Food | Class II | 1 |
| 23 Jun 2016 | The Fresh Market, Smoked Supreme Nut Mix, Net Wt. 12.3 oz. (349g), Distributed by: The Fresh Market, Inc., Greensboro, NC 27408, packed in clear plastic package. | Creative Snacks Co., LLC | Food | Class I | 1 |
| 22 Jun 2016 | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8… | Draeger Medical, Inc. | Device | Class II | 1 |
| 22 Jun 2016 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma. | Alere San Diego, Inc. | Device | Class III | 7 |
| 22 Jun 2016 | Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier. | LeMaitre Vascular, Inc. | Device | Class II | 7 |
| 22 Jun 2016 | Olympus Scientific Solutions Americas Corporation (“OSSA”) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta… | Olympus Scientific Solutions Americas | Device | Class II | 1 |
| 22 Jun 2016 | Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 22 Jun 2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16 | Teva North America | Drug | Class II | 1 |
| 22 Jun 2016 | The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4. | Northern Tier Bakery (dba\ Super Mom's) | Food | Class II | 1 |
| 21 Jun 2016 | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The… | Invacare Corporation | Device | Class II | 2 |
| 21 Jun 2016 | Raw Macadamias, 6 oz. clear plastic tubs, NET WT (170g) Whole Foods: Distributed by Whole Foods Market, Emeryville, CA: Ingredients: Macadamia Nuts; contains tree nuts. Product of Malawi: UPC: 9 99482 00132 5 Event 74483 | Marin Food Specialties Inc | Food | Class I | 1 |
| 21 Jun 2016 | Cherokee Rose Hand Made cheese, Produced by Nature’s Harmony in Berton, GA 30635. Event 74531 | Nature's Harmony LLC | Food | Class I | 1 |
| 20 Jun 2016 | Al Rasheed Sardine Item #4017 Label not available - NYSDAM sampling. Event 74491 | Greenland Trading Corp | Food | Class I | 1 |
| 20 Jun 2016 | GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service. | The Father's Table, LLC | Food | Class II | 6 |
| 20 Jun 2016 | Meduri Farms Dried Blueberries/Sugar Infused, Catalog #’s: 080282, 08028X, 08028, 080281, 08127X. Product is packaged in a BULK corrugated box with food grade plastic liner, net weight 10 lbs., 20 lbs., and 25 lbs. Event 74493 | Meduri Farms Inc | Food | Class I | 1 |
| 17 Jun 2016 | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 17 Jun 2016 | 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with… Event 74477 | NeoCoil, LLC | Device | Class II | 1 |
| 17 Jun 2016 | Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle. UPC 184368000114. The responsible firm name on the label is SCD Probiotics, Kansas City, MO 64106. Event 74429 | Sustainable Community Development LLC dba SCD Probiotics | Food | Class II | 1 |
| 16 Jun 2016 | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the… | Ab Sciex | Device | Class II | 4 |
| 16 Jun 2016 | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. | Halyard Health, Inc | Device | Class II | 1 |
| 15 Jun 2016 | Doritos Spicy Sweet Chili Flavored tortilla chips in 3 1/8 ounce bags | Frito-Lay, Inc | Food | Class I | 1 |
| 15 Jun 2016 | Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial Flavors, Plain Icing which are packaged in 2.7oz packages; Unit UPC code 2781500240 . There are 18 packages to a case, Case SKU 2781500240. The responsible firm name on the label is Armour-Eckrich Meats LLC, Cincinnati, OH 45240. Event 74428 | Armour Eckrich Meats Llc | Food | Class II | 1 |
| 15 Jun 2016 | Lance Oyster Crackers, Dist. by Snyder's-Lance, Inc., Charlotte, NC 28277 Event 74467 | S-L Snacks NC, LLC | Food | Class II | 1 |
| 15 Jun 2016 | Macaroni Salad with Cheddar Cheese is packaged in a plastic bag, each case contains 2/5 lbs. bags. The label listed item #23070 and the UPC 8 87241 80712 0. The product was also sold both in Zupan’s Markets service deli salad case, sized to order, and available in prepacked round plastic containers (8, 12 & 16 oz.)… Event 74443 | Zupan Enterprises, Inc. | Food | Class I | 1 |
| 15 Jun 2016 | Kroger DELUXE ICE CREAM S'MORES 48 FL OZ (1.5 QT) 1.4 ML INGREDIENTS: ICE CREAM***GRAHAM COOKIES***CHOCOLATE CHUNKS***CONTAINS: MILK, SOY, WHEAT, COCONUT. UPC 0 11110 01399 6 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 | The Kroger Co | Food | Class II | 1 |
| 14 Jun 2016 | Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 14 Jun 2016 | Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences.… | Hill-Rom, Inc. | Device | Class II | 1 |
| 14 Jun 2016 | Summer Vegetable Salad with Seared Chicken, Garlic Croutons, and Mustard-Chive Vinaigrette | HELLOFRESH | Food | Class I | 4 |
| 14 Jun 2016 | Cherry Cheesecake, 5 oz. | Spartan Stores | Food | Class II | 3 |
| 13 Jun 2016 | Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case. | Richard-Allan Scientific Company | Device | Class II | 1 |
| 13 Jun 2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69 | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 13 Jun 2016 | Coconut milk , 13.5 fld oz, can, 214x406 3 pieces steel tins ,24 tins per case. Refrigerate after opening. Event 74670 | Procesadora de Frutos y Vegetales del Caribe | Food | Class II | 1 |
| 10 Jun 2016 | Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V). Event 74545 | Name withheld | Device | Class II | 1 |
| 10 Jun 2016 | Deli-Food Ancho Chile Powder 50 lb corrugated boxes x 45 each. Event 74516 | Deli-Food Chili & Spice LLC | Food | Class I | 1 |
| 9 Jun 2016 | DF Mavens Chocolate Almond Fudge Frozen Bars, Net 11.52 fl. oz. (340 mL), 4 bars per box, each bar is 2.88 Fl. Oz., UPC 857756004772 --- DF Mavens, a subsidiary of FAL FOODS USA Inc., 24-20 49th Street - Astoria, NY 11103 --- Product is labeled as "Dairy Free". Event 74377 | Fal Foods Usa | Food | Class I | 1 |
| 8 Jun 2016 | Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches. | CH Guenther & Sons, Inc | Food | Class II | 2 |
| 7 Jun 2016 | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction. | Tosoh Bioscience, Inc. | Device | Class III | 1 |
| 7 Jun 2016 | Diced and sliced yellow onions. 2.5 lb & 5 lb clear plastic bags | Club Chef LLC | Food | Class I | 1 |
| 6 Jun 2016 | Sunflower Kernals packaged in a 5.5 OZ clear plastic bag labeled in part " Stuckey's Family Favorites". UPC code 091976440075 Event 74398 | Taylor's Candy, Inc. | Food | Class I | 1 |
| 6 Jun 2016 | Rold Gold Tiny Twists 1 oz., 2 oz., 16 oz., and 20 1/2 oz.; Rold Gold Original Pretzel Thins 4 oz. and 16 oz.; Rold Gold Sticks 16 oz. packaged in flexible plastic bags. | Frito-Lay, Inc | Food | Class II | 7 |
| 3 Jun 2016 | Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 3 Jun 2016 | MaraNatha All Natural Sunflower Seed Butter, NET WT 12 OZ (340g)., UPC 0 51651-09367 5 | The Hain Celestial Group, Inc. - Worldwide HQ | Food | Class I | 1 |
| 2 Jun 2016 | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 2 Jun 2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY Event 74744 | Exact-Rx Inc | Drug | Class III | 1 |
| 2 Jun 2016 | Salad topping labeled under the following brand names: (Product 1) Durkee Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 047600091366. The responsible firm name on the label is ACH Food Companies, Inc. Memphis, TN; (Product 2) Hy-Vee Garden Style Salad Topping in plastic bottle,… Event 74313 | Ach Food Companies Inc | Food | Class I | 1 |
| 31 May 2016 | METS SMILES Total Knee Replacement | Stanmore Implants Worldwide Ltd. | Device | Class II | 1 |
| 31 May 2016 | Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators. | Draeger Medical, Inc. | Device | Class I | 1 |
| 31 May 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Teva North America | Drug | Class III | 1 |
| 31 May 2016 | Honey Bunchies Gourmet Honey Bars, 1.9 oz. snack bar containing honey, sunflower kernels, peanuts and pecans. Packaging: Box containing 20 individual bars in plastic wrappers. Manufactured by: Honey Bunchie, LLC, Longmont, CO. Individual Bar UPC 8 66192 00010 1; Box of 20 Bars UPC 8 66192 00011 8. Event 74485 | Honey Bunchie, LLC | Food | Class I | 1 |
| 26 May 2016 | ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 26 May 2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL. Event 74519 | Stratus Pharmaceuticals Inc | Drug | Class III | 1 |
| 24 May 2016 | ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim 16oz (453G) INGREDIENTS: SUNFLOWER SEEDS ROASTED IN SUNFLOWER AND OR PEANUT OIL UPC 0 82987 05874 8 & Windy Acres 8 OZ (22 G) UPC 0 82987 30172 1 & 5 lb plastic bag WILMINGTON, OH 45177 | Windy Acres Candy & Nut, Outlet Inc. | Food | Class I | 2 |
| 23 May 2016 | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. | Synthes (USA) Products LLC | Device | Class II | 6 |
| 23 May 2016 | Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist Code #C51140/51140 | Name withheld | Food | Class I | 39 |
| 20 May 2016 | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds. | Merz North America, Inc. | Device | Class II | 1 |
| 19 May 2016 | Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes. | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 19 May 2016 | Sun Life Natural Sunflower Kernel Paste, Net Wt. 40 lbs (18.18 kg) buckets and 450 lbs. (204.12 kg) barrels. The responsible name on the label is Nu Life Market, LLC, Scott City, KS. | Nu Life Market LLC | Food | Class I | 5 |
| 18 May 2016 | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine.… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 18 May 2016 | Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator. | Conmed Corporation | Device | Class II | 5 |
| 18 May 2016 | Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01. | Teva North America | Drug | Class III | 1 |
| 13 May 2016 | Haitai Matdongsan Peanuts Crunch Snack, Net Wt. 11.49 oz. (325gr), Imported and Distributed by: Haitai, Inc, 7227 Telegraph Road, Montebello, CA 90640 - H & E Trading Inc, 514 Eugene Way, Wyckoff, NJ 07481, UPC 8 801019606786 Event 74611 | H & E Trading Inc | Food | Class II | 1 |
| 11 May 2016 | Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication. | Medline Industries Inc | Device | Class II | 1 |
| 6 May 2016 | Endotine Transbleph 3.5 (CFD-080-0167) | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 6 May 2016 | Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease. Event 74637 | BEST THERATRONICS LTD. | Device | Class II | 1 |
| 6 May 2016 | Harris Teeter Organics Mixed Vegetables, 16oz bags (product labeling not available). | Harris Teeter Distribution Ctr | Food | Class I | 2 |
| 5 May 2016 | Creative Snacks Brain Food, 3.5 oz. Snack Bag, UPC 816512015124, 10 lb. Bulk, UPC 816512013021, 9.5 oz. cup, UPC 855983002073; Fresh Market Brain Food, 25 lb. Bulk, UPC N/A, 9.5 oz. cup, UPC 737094218270, | Creative Snacks Co., LLC | Food | Class I | 7 |
| 4 May 2016 | ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid… Event 74781 | Reshape Medical Inc | Device | Class II | 1 |
| 3 May 2016 | Sunflower Seeds, PLU# 65167; various weights; various sell by dates; Market District; Distributed by Giant Eagle, Pittsburgh, PA 15238 | Giant Eagle, Inc. | Food | Class I | 1 |
| 2 May 2016 | Organic Blueberries, Brand Columbia River Organics, Net Wt. 10 oz, UPC 5711000125 Wild Blueberries, Brand O Organic, Net Wt. 10 oz, UPC 7989340654 | CRF Frozen Foods, LLC | Food | Class I | 23 |
| 2 May 2016 | Mix Vegetables, brand JFDA (label in Japanese), frozen, net wt. 1 kg., UPC 991438945321 Mixed Vegetables, brand Mountain Mist, frozen, net wt. 1 kg., UPC 4635800055 The ingredients statement declares: Carrots, Corn, and Peas. | CRF Frozen Foods, LLC | Food | Class I | 27 |
| 29 Apr 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 6 |
| 23 Apr 2016 | 7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE NET WT. 4.0 OZ UPC: 052548558741 | Bakery Express of Southern California | Food | Class I | 2 |
| 20 Apr 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 15 Apr 2016 | Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic | Cook Inc. | Device | Class II | 14 |
| 15 Apr 2016 | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging Inc | Device | Class II | 6 |
| 6 Apr 2016 | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent… | Pentax Medical Company | Device | Class II | 6 |
| 6 Apr 2016 | IQF 1/4" Yellow Onion Dice, frozen, item numbers: 103364, 103381, and 104831, bulk cases, net wt. 45 lbs.; 11244CH Onion Dice 1/4, frozen, item number 103381, bulk cases, net wt. 45 lbs. Onion, Diced 1/4" IQF 45#CS, item number 104155, bulk cases, net wt. 45 lbs. | Oregon Potato Company | Food | Class I | 9 |
| 29 Mar 2016 | CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12.4 OZ (351g) INGREDIENTS: ***CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURES***. CONTAINS WHEAT. MAY CONTAIN MILK, EGGS, SOY, PEANUTS AND TREE NUTS. DISTRIBUTED BY: PRICE CHOPPER, INC. SCHENECTADY, NY 12306 UPC 0 41735… Event 73675 | English Bay Batter Inc (Toronto) US Division | Food | Class II | 1 |
| 24 Mar 2016 | Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery | Teleflex Medical | Device | Class II | 1 |
| 24 Mar 2016 | Brilliance 64 Computed Tomography X-ray systems is 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 | 7 |
| 15 Mar 2016 | Invacare Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours. | Invacare Corporation | Device | Class II | 4 |
| 4 Mar 2016 | Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles. Keep Refrigerated. 8oz UPC 0 91037 56624 9 | Name withheld | Food | Class I | 2 |
| 2 Mar 2016 | GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis. | GE Inspection Technologies, LP | Device | Class II | 1 |
| 5 Feb 2016 | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples,… | Beckman Coulter Inc. | Device | Class II | 1 |
| 5 Feb 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 2 Feb 2016 | S3 MedSurg Bed, Model 3005. Stryker Medical | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 31 Jan 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 30 Jan 2016 | iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. | Merge Healthcare, Inc. | Device | Class II | 2 |
| 30 Jan 2016 | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 30 Jan 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 30 Jan 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 12 Jan 2016 | Ice Nuggets, 10 lb plastic bag, UPC 3977919140. | Kwik Trip, Inc. | Food | Class II | 1 |
| 3 Dec 2015 | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the… | Teleflex Medical | Device | Class II | 1 |
| 25 Nov 2015 | Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants | Biomet 3i, LLC | Device | Class II | 119 |
| 17 Nov 2015 | Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ Event 72849 | Casey's Bakery, Inc | Food | Class II | 1 |
| 9 Nov 2015 | Healthwise, Protein Chips, Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA 30813. Event 72625 | Nutritional Resources Inc | Food | Class II | 1 |
| 19 Oct 2015 | Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC | Northwest Wild Products | Food | Class II | 16 |
| 5 Oct 2015 | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical, Inc. | Device | Class II | 4 |
| 30 Jul 2015 | AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories. | Beckman Coulter Inc. | Device | Class II | 3 |
| 23 Jul 2015 | Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 30 Jun 2015 | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 20 Nov 2014 | whole milk yogurt is packaged in a 32 oz. glass jar, sold under brand Flying Cow Creamery. The UPC is 7 13757 87133 4. The product is labeled in parts: "***FLYING COW CREAMERY***Whole Milk Yogurt***209 HYPPA ROAD EAST, ROCHESTER, WASHINGTON 98579***". Event 69828 | Flying Cow Creamery | Food | Class II | 1 |
| 3 Nov 2014 | LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY | House Of Spices (india) Inc. | Food | Class I | 1 |
| 22 Apr 2014 | UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800… | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Oct 2013 | 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 17 Sep 2013 | Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories,… | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 3 |
| 10 Sep 2013 | Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER;… | Hospira Inc. | Device | Class II | 2 |
| 8 Aug 2013 | Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect… | Teleflex Medical | Device | Class II | 1 |
| 18 Feb 2013 | Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire,… | Ge Healthcare It | Device | Class II | 1 |
| 15 Nov 2012 | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review… | GE Healthcare It | Device | Class II | 1 |
| 2 Jul 2012 | Merge HEMO software. | Merge Healthcare, Inc. | Device | Class II | 1 |