| 2 Jan 2015 | Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059 | SCA Pharmaceuticals | Drug | Class II | 1 |
| 31 Dec 2014 | Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14. | Valeant Pharmaceuticals North America LLC | Drug | Class II | 1 |
| 29 Dec 2014 | Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be… Event 70136 | Name withheld | Device | Class II | 1 |
| 26 Dec 2014 | Liposomal Amphotericin B 130 mg in dextrose bags | Walgreens Infusion Services | Drug | Class II | 36 |
| 22 Dec 2014 | Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of… | Cordis Corporation | Device | Class II | 1 |
| 22 Dec 2014 | ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 22 Dec 2014 | 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11 | Hospira Inc. | Drug | Class II | 1 |
| 22 Dec 2014 | Tofu Pad Thai Bowl. PERISHABLE, KEEP REFRIGERATED. Net Wt. 13.5 oz UPC 0 30223 00914 6 | Real Foods of Seattle, LLC | Food | Class I | 2 |
| 19 Dec 2014 | Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders. | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 19 Dec 2014 | CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions. | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 19 Dec 2014 | McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices. Event 70144 | McKesson Israel Ltd. | Device | Class II | 1 |
| 19 Dec 2014 | GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner. | GE Healthcare | Device | Class II | 1 |
| 19 Dec 2014 | lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 | SpineFrontier, Inc. | Device | Class II | 1 |
| 19 Dec 2014 | 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144 Event 70261 | 3M Company/3m Espe Dental Products | Drug | Class III | 1 |
| 19 Dec 2014 | Roland brand Bruschetta, Italian-Style Appetizer, NET WT. 12 OZ. (340g), Item 46740, UPC 41224467408, PRODUCT OF TURKEY ---The product is packaged in a glass jar, 12 x 12 oz. jars per case. Event 70098 | American Roland Food Corp. | Food | Class II | 1 |
| 19 Dec 2014 | Sweet Blueberry Almonds - Blueberry Flavored Almonds. Ingredients: Almonds, Sugar, Natural Flavor, Vegetable Color (Red Cabbage Juice Extract), Beet Juice Concentrate. May also contain other tree nuts, peanuts, milk, wheat, egg. Packaged in the following configuration: 4 oz (113 gr) stand up pouch; 5 lbs. (80 oz)… | NatureBox, Inc. | Food | Class II | 1 |
| 19 Dec 2014 | Perfect Bar Peanut Butter, size 2.5 oz, UPC 8-55569-00302-9, 144 units/case | Perfect Foods Bar | Food | Class I | 3 |
| 18 Dec 2014 | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues. | Roche Molecular Systems, Inc. | Device | Class III | 1 |
| 18 Dec 2014 | Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries. Event 70024 | Ziemer Usa Inc | Device | Class II | 1 |
| 18 Dec 2014 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device. | Spinal Elements, Inc | Device | Class II | 1 |
| 18 Dec 2014 | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter | St Jude Medical Cardiac Rhythm Management Division | Device | Class II | 1 |
| 17 Dec 2014 | Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN Event 70084 | Tropichem Research Labs, Inc. | Drug | Class II | 1 |
| 16 Dec 2014 | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8” product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient’s vascular system… | Arrow International Inc | Device | Class II | 1 |
| 16 Dec 2014 | ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 16 Dec 2014 | J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30. Event 70085 | Jaymac Pharmaceuticals L.L.C. | Drug | Class II | 1 |
| 15 Dec 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is 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… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 Dec 2014 | PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is… Event 70012 | Genetic Testing Institute,inc | Device | Class II | 1 |
| 15 Dec 2014 | Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating… | Synthes, Inc. | Device | Class II | 1 |
| 15 Dec 2014 | Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed… | Actavis Elizabeth LLC | Drug | Class II | 3 |
| 15 Dec 2014 | Hors D'Oeuvre, Holiday Foods Breaded Macaroni & Cheese Bites (item number 4802280). UPC 70220748022808, Keep Frozen, For Institutional Use Only, Contains: 100 - 0.7 oz PCS. | Schwan Food Company dba Holiday Foods | Food | Class II | 3 |
| 12 Dec 2014 | MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed… | Biocare Medical Llc | Device | Class II | 1 |
| 12 Dec 2014 | Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376. | Right Value Drug Stores, Inc. | Drug | Class II | 1 |
| 11 Dec 2014 | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. | Mentor Texas, LP. | Device | Class II | 1 |
| 11 Dec 2014 | Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck. | Med Tec Inc | Device | Class II | 2 |
| 10 Dec 2014 | GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic… | GE Healthcare | Device | Class II | 1 |
| 10 Dec 2014 | Citizen Chef Organic Superfood Salad- 4 Organic Salads. Power Greens, Walnuts, Feta, Dried Cranberries and Blueberries with Pomegranate Vinaigrette. Net Wt. 4.5 oz. (142g) USDA Organic UPC 30233 20009 Taylor Farms Pacific Stockton, CA. 95376 | Taylor Farms Pacific Inc. (MacArthur Facility) | Food | Class II | 1 |
| 9 Dec 2014 | Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60). | Akorn, Inc. | Drug | Class III | 1 |
| 9 Dec 2014 | Harvest Blend, Net Wt. 4 oz. (113g) Best If Enjoyed By: 12/05/2014, DISTRIBUTED BY 7-ELEVEN, INC., DALLAS, TX 75201 UPC 052548558253 | Del Monte Fresh Produce NA, Inc | Food | Class I | 13 |
| 8 Dec 2014 | Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants. | Zimmer, Inc. | Device | Class II | 1 |
| 8 Dec 2014 | Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 8 Dec 2014 | GE Healthcare, Proteus XR/a with wall stand model number 600-0301. | GE Healthcare | Device | Class II | 1 |
| 5 Dec 2014 | IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 5 Dec 2014 | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro… | Alere San Diego, Inc. | Device | Class I | 3 |
| 5 Dec 2014 | Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream; 1.5 quart round paper carton with lid. | Safeway Inc | Food | Class I | 1 |
| 4 Dec 2014 | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria. | Ev3, Inc. | Device | Class II | 2 |
| 4 Dec 2014 | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen… | Hansen Medical Inc | Device | Class II | 1 |
| 4 Dec 2014 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and… | Orthovita, Inc., dBA Stryker Orthobiologics. | Device | Class II | 2 |
| 4 Dec 2014 | Abdallah Milk Chocolate Bites CARAMEL, Net Wt 4.5 oz. (127g), UPC 7 6668407116 2, Ingredients: Pure milk chocolate (sugar, chocolate liquor, cocoa butter, whole milk, soy lecithin (an emulsifier), vanilla), corn syrup, sweetened condensed milk, cream, sugar, palm oil, salt, guar gum. carrageenan, locust bean gum,… Event 69944 | Abdallah Candies, Inc | Food | Class I | 1 |
| 3 Dec 2014 | Ferno Model 35X PROFlexx Stretchers, one unit per package | Ferno-Washington Inc | Device | Class II | 1 |
| 3 Dec 2014 | Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from… | Trumpf Medical Systems, Inc. | Device | Class II | 12 |
| 3 Dec 2014 | SOMATOM Force; 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 | 1 |
| 3 Dec 2014 | Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Dec 2014 | POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent. | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 3 Dec 2014 | Jumbo Lump Crab Cakes packed from bulk into clam shell containers with Giant Eagle scale label 100% Jumbo Lump Crab Cake Sell by Date: any date Net Wt. any weight Giant Eagle Market District Distributed by Giant Eagle, Pittsburg, PA 15328 | Giant Eagle, Inc. | Food | Class I | 1 |
| 2 Dec 2014 | Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 2 Dec 2014 | Open Nature Chile Cheese Enchilada Two enchiladas filled with a queso fundido cheese mix topped with guajillo sauce and Mexican cheeses KEEP FROZEN COOK THOROUGHLY NET WT 9 OZ (255 g) COOKING INSTRUCTIONS FOR FOOD SAFETY, FOLLOW THESE COOKING INSTRUCTIONS. PRODUCT NEEDS TO BE THOROUGHLY COOKED. MICROWAVE OVEN… Event 69924 | Overhill Farms Inc | Food | Class I | 1 |
| 1 Dec 2014 | EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and… | Stelkast Co | Device | Class II | 1 |
| 1 Dec 2014 | Organic Southwest Seasoning, Item no. 12785 and Organic Southwestern Seasoning, Item no. 12835, Net Wt. 50 lbs. (22.6 kg). The product is labeled in parts: "***Organic Southwest Seasoning***12785 ***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***". The product is labeled in parts: "***Organic… | Regency Group, Inc., The | Food | Class I | 2 |
| 26 Nov 2014 | Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff. | Steris Corporation | Device | Class II | 1 |
| 26 Nov 2014 | Cilantro Flakes Organic, sold under private label Azure Farm, Net wt. 4 oz. or 1 lb. Product is packed in the heat seal poly bag. The 4 oz. bag has UPC 8 70722 00256 5. The 1 lb. bag has UPC 8 70722 00255 8. The 4 oz bag is labeled in parts: "***Cilantro Flakes Organic***GLUTEN FREE GMO-FREE***Azure Farm***Net Wt 4… Event 69941 | K F K Seasonings Llc | Food | Class I | 1 |
| 26 Nov 2014 | Organic Cilantro Medium Bulk - size is dependent on customer request; Certified Organic by QAI High Quality Organics Reno, NV; Product of Israel | High Quality Organics, Inc. | Food | Class I | 1 |
| 25 Nov 2014 | SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per… Event 70045 | Nonin Medical, Inc | Device | Class II | 1 |
| 25 Nov 2014 | Vintage Pure Bee Flower Honey, Net Weight 16.4 oz (465g), Packaged in a Glass Jar, Product of Turkey, Imported by: Vintage Food Corp., 849 Newark Tpke, Kearny, NJ 07032, USA, UPC 603608629903 | Vintage Food Corp. | Food | Class III | 1 |
| 24 Nov 2014 | Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Nov 2014 | HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977 | Par Pharmaceutical Inc. | Drug | Class II | 1 |
| 24 Nov 2014 | Clear 1 lb packages of Natto Soybean Sprouts. These products are labeled as produced by Henrys Farm Inc. | Henrys Farm Inc. | Food | Class I | 3 |
| 24 Nov 2014 | Flat Creek Lodge, Aztec Cheddar Cheese, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401. | Flat Creek Farm & Dairy | Food | Class I | 2 |
| 21 Nov 2014 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues,… | Atricure Inc | Device | Class II | 1 |
| 21 Nov 2014 | Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge” Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe. | Smiths Medical ASD, Inc. | Device | Class II | 3 |
| 20 Nov 2014 | ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling… | Roche Diagnostics Operations, Inc. | Device | Class II | 12 |
| 20 Nov 2014 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for… | Phadia US Inc | Device | Class II | 1 |
| 20 Nov 2014 | GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY Event 69836 | Name withheld | Drug | Class II | 1 |
| 19 Nov 2014 | iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. | Brainlab AG | Device | Class II | 2 |
| 19 Nov 2014 | CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting. | KCI USA, INC. | Device | Class II | 1 |
| 19 Nov 2014 | Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of… | Boston Scientific Corporation | Device | Class I | 3 |
| 19 Nov 2014 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 14 Nov 2014 | Powered stretcher chair used during facial and eye surgeries. One chair per package. Event 69671 | TransMotion Medical Inc | Device | Class II | 1 |
| 13 Nov 2014 | FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic… Event 70007 | Aptalis Pharmatech Inc. | Device | Class II | 1 |
| 13 Nov 2014 | ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 13 Nov 2014 | QuestBar Protein Bar Double Chocolate Chunk Flavor NET Wt. 2.12 OZ (60g) Lot #: 1BA4DCC14289 Exp Date: October 17, 2015 UPC Codes: - individual bar: 7-93573-22592-4 - caddie: 7-93573-22591-7 The protein bar is wrapped in a plastic wrapper containing labeling information. The bars are placed into cardboard boxes… | Quest Nutrition, LLC. | Food | Class II | 2 |
| 12 Nov 2014 | I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 11 Nov 2014 | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Event 70009 | Vision Rt Inc | Device | Class II | 1 |
| 10 Nov 2014 | Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial… | DePuy Orthopaedics, Inc. | Device | Class II | 3 |
| 10 Nov 2014 | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive… Event 69806 | CSA Medical | Device | Class II | 1 |
| 10 Nov 2014 | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of today’s microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for… | Tecan US, Inc. | Device | Class III | 2 |
| 10 Nov 2014 | The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 10 Nov 2014 | Pride of the Redlands brand Florida green skin avocado, 12ct,14ct, 16ct, 18ct, and 20ct packaged in 1/2 bushel boxes Event 69833 | Unity Groves Corporation | Food | Class I | 1 |
| 7 Nov 2014 | Whole Foods Organic Raw Almonds Imported from Spain USDA Organic; Net WT. 13.5 oz. (383 g) plastic tub; Ingredients: Organic Almonds - Unpasteurized Distributed by Whole Foods Market IP, LP, Emeryville, CA 94608 Event 69725 | Marin Food Specialties Inc | Food | Class II | 1 |
| 6 Nov 2014 | Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 4 Nov 2014 | Baroody Pickled Labneh with Pepper, Net Wt. 20 oz., (1 lb. 4 oz.), 575-g, in sealed glass jar, UPC 642036010549 | Baroody Imports Inc. | Food | Class III | 2 |
| 30 Oct 2014 | MRS FRIDAY'S GOURMET BREADED MEDIUM OYSTERS 18/25 CT/LB, Net Wt. 2.5 lbs (1.13 kg), Ready to Fry, Distributed by: King and Prince Seafood Corporation, Brunswick, GA 31621 Event 69878 | King & Prince Seafood | Food | Class II | 1 |
| 27 Oct 2014 | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. | Straumann USA, LLC | Device | Class II | 1 |
| 23 Oct 2014 | Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) | Centurion Medical Products Corporation | Device | Class II | 4 |
| 22 Oct 2014 | Philips Expression MR200 MRI Patient Monitoring System. | Invivo Corporation | Device | Class II | 1 |
| 17 Oct 2014 | Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5. | Aurobindo Pharma USA Inc | Drug | Class II | 1 |
| 9 Oct 2014 | Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants | Exactech, Inc. | Device | Class II | 1 |
| 8 Oct 2014 | Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion. | Ebi, Llc | Device | Class II | 1 |
| 6 Oct 2014 | HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 6 Oct 2014 | Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures | PEROUSE MEDICAL | Device | Class II | 2 |
| 29 Sep 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 24 Sep 2014 | GOLD STAR'S FINEST COLD SMOKED STEELHEAD, Net Wt. (To Be Weighed At Time of Sale). UPC 021 143140026. Product is sold in a Vacuum Pack with blue and gold label. PERISHABLE. KEEP REFRIGERATED. Distributed by: Gold Star 570 Smith Street Brooklyn, NY 11231, 718-522-1545. Event 69332 | Gold Star Smoked Fish Corp. | Food | Class I | 1 |
| 17 Sep 2014 | Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 Sep 2014 | GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize. | GE OEC Medical Systems, Inc | Device | Class II | 2 |
| 10 Sep 2014 | Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens | Intertrade Imports Inc. | Device | Class II | 2 |
| 21 Aug 2014 | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices. | Maquet Medical Systems USA | Device | Class II | 1 |
| 12 Aug 2014 | The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 3 |
| 8 Aug 2014 | IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device. Event 69751 | Sun Nuclear Corporation | Device | Class II | 1 |
| 6 Jun 2014 | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and… | Becton Dickinson & Co. | Device | Class II | 3 |
| 24 Apr 2014 | Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 8 Apr 2014 | e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 5 Mar 2014 | Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 3 Dec 2013 | Lumbar Extension Machine for Physical Therapy | MedX Holdings, Inc. | Device | Class II | 2 |
| 23 Nov 2013 | The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. Event 69300 | Name withheld | Device | Class II | 1 |
| 26 Sep 2013 | CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 2 |
| 22 Aug 2013 | Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the… | Biomet Spine, LLC | Device | Class II | 1 |
| 22 Aug 2013 | Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 8630‐0204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. | Biomet Spine, LLC | Device | Class II | 1 |
| 22 Aug 2013 | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. | Biomet Spine, LLC | Device | Class II | 1 |
| 16 Jun 2013 | The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 4 Feb 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX,… | Arrow International Inc | Device | Class II | 1 |