| 4 Apr 2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19 | West-Ward Columbus, Inc. | Drug | Class III | 1 |
| 3 Apr 2017 | ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732 | Medisca, Inc. | Drug | Class II | 4 |
| 31 Mar 2017 | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 29 Mar 2017 | Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. | Teleflex Medical | Device | Class III | 1 |
| 29 Mar 2017 | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound… | Volcano Corporation | Device | Class II | 2 |
| 28 Mar 2017 | Artis zee, Angiographic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 28 Mar 2017 | 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements. Event 76920 | Name withheld | Device | Class II | 1 |
| 28 Mar 2017 | Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use… | Draegar Medical Systems, Inc. | Device | Class II | 3 |
| 28 Mar 2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T… | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 1 |
| 27 Mar 2017 | Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components | Alcon Research, Ltd. | Device | Class II | 1 |
| 27 Mar 2017 | French's Crispy Jalapenos Net Wt. 5 oz. (141.7g), UPC 0 41500 95309 0, French's Food Company. Event 76864 | The French's Food Company, LLC SUBS Reckitt Benckiser | Food | Class II | 1 |
| 24 Mar 2017 | Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06) | Qinhuangdao Zizhu Pharmaceutical, Co. | Drug | Class II | 7 |
| 24 Mar 2017 | MIXED NUT MOONCAKES (Trung Thu Thap Cam), individually packaged in clear wrap, with a printed label on top. Best by date is printed on the label. 5 oz/142 grams per unit with UPC code 015200401274 | Sunshine Bakery | Food | Class I | 2 |
| 23 Mar 2017 | Soy Bits and Soy Splits, Organic, Roasted Not Salted, Individual Super Sac (1450 pounds Soy Bits and 1400 - 1600 pound Soy Splits) Event 76845 | Name withheld | Food | Class II | 1 |
| 22 Mar 2017 | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 722038; Allura Xper FD20/20 biplane OR… | Philips Electronics North America Corporation | Device | Class II | 3 |
| 22 Mar 2017 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20. | GlaxoSmithKline, LLC | Drug | Class II | 1 |
| 22 Mar 2017 | Venison Jerky, brand Trophy Series, heat treated shelf stable packaged in hermetically sealed packages. Net wt. 3 oz. UPC 16831 00519. | Whiskey Hill Smokehouse | Food | Class II | 4 |
| 22 Mar 2017 | ChloroFields Micro-greens Asian Mix, Net Wt. 1.5 OZ, packed in clear plastic clamshells Event 76813 | ChloroFields | Food | Class I | 1 |
| 22 Mar 2017 | Private House brand Almond Drinking Powder in 600 g cans, 12 cans per case | FENG MAO BIOTECHNOLOGY ORGANIC FOOD CO., LTD. | Food | Class I | 2 |
| 21 Mar 2017 | Proteus 235, Proton Therapy System | Ion Beam Applications S.A. | Device | Class II | 1 |
| 21 Mar 2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 1 |
| 20 Mar 2017 | Tapered SwissPlus Implant System, Model No. SPB10 | Zimmer Dental Inc | Device | Class II | 1 |
| 20 Mar 2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. | Mylan Pharmaceuticals Inc. | Drug | Class II | 4 |
| 20 Mar 2017 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080. | G & W Laboratories, Inc. | Drug | Class III | 1 |
| 20 Mar 2017 | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04 | Valeant Pharmaceuticals North America LLC | Drug | Class III | 2 |
| 20 Mar 2017 | Kwei Chow brand Prime Spicy Pot Paste, net weight 7.10 Oz, sauce in glass jars, shelf stable | Kwei Chow Sauce Industry Co., Ltd. | Food | Class II | 3 |
| 20 Mar 2017 | Buttermilk Powder, 25kg (BX25) Grade A | United Dairymen of Arizona | Food | Class I | 5 |
| 20 Mar 2017 | 20/20 LifeStyles Yogurt Peanut Crunch Bar. Bar UPC 7 8571 00052. Each bar has net weight 2 oz. Box UPC 7 8571 00053. Each box has 12/2 oz. bars. Case UPC 78571 00054. Each case has 12 boxes and it is for shipment only and not for resale. Event 76799 | Pro Sports Club | Food | Class I | 1 |
| 20 Mar 2017 | Turkey wedge sandwich. Prepared by Gourmet Classic Salads 240 E Bullard Ave. Lake Wales, FL 33853 | Gourmet Classic Salads, Inc. | Food | Class I | 9 |
| 17 Mar 2017 | CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 17 Mar 2017 | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human… | BioMerieux SA | Device | Class II | 1 |
| 17 Mar 2017 | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 Event 76761 | Shire | Drug | Class II | 1 |
| 17 Mar 2017 | LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12 | Akorn, Inc. | Drug | Class II | 1 |
| 17 Mar 2017 | Ronzoni(R) Thin Spaghetti, NO. 9, ENRICHED MACARONI PRODUCT, NET WT 16 OA (454g)., UPC 71300 00009 | Riviana International, Inc | Food | Class I | 1 |
| 17 Mar 2017 | Nutiva Nuture Vitality Organic Plant Protein Superfood 30 Shake - Vanilla; Product # PBP201 - 10-1.2 oz. packets; Packet UPC/Caddy UPC: 6-92752-10716-0; 6-92752-10717-7; Master Case UPC: 6-92752-10718-4. Product # PBP205 - 21.6 oz. HDPE jar; Unit UPC: 6-92752-10711-5; Master Case UPC: 6-92752-10712-2 USDA Organic… | Nutiva | Food | Class I | 2 |
| 16 Mar 2017 | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered… | Becton Dickinson & Company | Device | Class II | 1 |
| 16 Mar 2017 | Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure | Windstone Medical Packaging, Inc. | Device | Class II | 18 |
| 16 Mar 2017 | Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration… | Zimmer Biomet Spine, Inc | Device | Class II | 1 |
| 16 Mar 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08. | Allergan Sales, LLC | Drug | Class III | 1 |
| 16 Mar 2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 15 Mar 2017 | Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing. | Avid Medical, Inc. | Device | Class II | 1 |
| 15 Mar 2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone | Smith & Nephew, Inc. | Device | Class II | 14 |
| 15 Mar 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical 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… | Intuitive Surgical, Inc. | Device | Class II | 16 |
| 15 Mar 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 14 Mar 2017 | Shred Carrots, 3 lb Food Service plastic bag. | J & J Distributing Company | Food | Class II | 8 |
| 13 Mar 2017 | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). | Nihon Kohden America Inc | Device | Class II | 1 |
| 13 Mar 2017 | NEODENT CM Intraoral Scanbody, Article Number: 108.139 Event 76843 | Instradent USA, Inc. | Device | Class II | 1 |
| 13 Mar 2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01. | Genentech Inc. | Drug | Class II | 1 |
| 13 Mar 2017 | AFC Edamame Soybeans in Pods, 8 oz , refrigerated, in cardboard container. UPC 0-23012-00261-9 Event 76771 | Advanced Fresh Concepts Corp | Food | Class I | 1 |
| 11 Mar 2017 | iXL Advanced Performance Matrix, Nutritional Premix, Net Wt. 50 lbs., Item No. 136375. | McShare's Inc | Food | Class III | 2 |
| 10 Mar 2017 | Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. | GE Healthcare, LLC | Device | Class II | 2 |
| 10 Mar 2017 | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Beckman Coulter Inc. | Device | Class II | 1 |
| 10 Mar 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24 | Claris Lifesciences Inc | Drug | Class II | 4 |
| 10 Mar 2017 | Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars; 3 - 3 FL oz.. bars (9 FL ox (266 ml) | Nestle USA | Food | Class II | 1 |
| 9 Mar 2017 | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K | Keystone Dental Inc | Device | Class II | 1 |
| 9 Mar 2017 | Proteus 235 | Ion Beam Applications S.A. | Device | Class II | 1 |
| 9 Mar 2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 9 Mar 2017 | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile. | C.R. Bard, Inc. | Device | Class II | 1 |
| 9 Mar 2017 | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic | Smith & Nephew, Inc. | Device | Class II | 4 |
| 9 Mar 2017 | POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components. | Centurion Medical Products Corporation | Device | Class II | 7 |
| 9 Mar 2017 | Pan Pita with soynut butter spread on top, 4" pita. Manufactured by Greater Miami Caterers 4001 NW 31 Ave., | Greater Miami Caterers, Inc. | Food | Class I | 5 |
| 9 Mar 2017 | LIDIA'S MARINARA, NET WT 25 oz (708g), UPC 897712001018 --- Manufactured for Nonna Foods LLC Woodbury, NY 11797 Event 76689 | NONNA FOODS | Food | Class I | 1 |
| 9 Mar 2017 | RegeneSlim | VivaCeuticals, Inc. dba Regeneca Worldwide | Food | Class II | 7 |
| 8 Mar 2017 | Ferno PROFlexx Model 28Z Chair Cot | Ferno-Washington Inc | Device | Class II | 1 |
| 8 Mar 2017 | Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 8 Mar 2017 | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled “Sterile" | Biomet 3i, LLC | Device | Class II | 1 |
| 8 Mar 2017 | hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc. Event 76863 | Mckesson Medical Surgical | Drug | Class II | 1 |
| 8 Mar 2017 | Nestle Butterfinger Peanut Butter Crisp Chocolate Candy Bar in 3-pack SharePack (2.01 oz); and in 6-pack Snack Tray (4.02oz) | Nestle USA | Food | Class II | 1 |
| 8 Mar 2017 | Vulto Creamery Ouleout soft wash-rind raw milk cheese cut and wrapped in clear plastic | Whole Foods Market | Food | Class I | 5 |
| 8 Mar 2017 | Pecorino Balze Volteranne DOP Societa Agricola Fattoria Lischeto srl, 1.5 kg/wheel. Event 76704 | Pondini, inc. | Food | Class I | 1 |
| 8 Mar 2017 | Gerber Pasta Pick-Ups Cheese Ravioli Net Wt 6 oz (170g) Drained Wt 3 oz (85g) UPC 01500000907-6, Truncated - written on package as: UPC 159070 | Gerber Products Company dba Nestle Infant Nutrition | Food | Class II | 1 |
| 7 Mar 2017 | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens | BioMerieux SA | Device | Class II | 1 |
| 7 Mar 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class II | 1 |
| 7 Mar 2017 | Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 3 |
| 7 Mar 2017 | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 7 Mar 2017 | Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set | Cook Inc. | Device | Class II | 1 |
| 7 Mar 2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 7 Mar 2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01. | Alvogen, Inc | Drug | Class III | 9 |
| 7 Mar 2017 | Klassic COCONUT DESSICATED COCONUT, 25 LBS. NET, ORGANIC MEDIUM BMO25, PRODUCT OF PHILIPPINES Event 76674 | Van Amerongen & Son, Inc. | Food | Class I | 1 |
| 6 Mar 2017 | Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 6 Mar 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 6 Mar 2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2 | GSK Consumer Healthcare | Drug | Class II | 1 |
| 6 Mar 2017 | RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60 Event 76699 | Name withheld | Drug | Class III | 1 |
| 6 Mar 2017 | Wegmans Milk Chocolate Sucker, NET WT 3 OZ. The product is shipped within a carton labeled with an orange label as WEGMANS SWISS RECIPE Milk Chocolate Big Ear Bunny Sucker (3 oz 36 count case). The individual product contains a lavender label and read Wegmans Milk Chocolate Sucker, comes in a 3-oz., clear plastic… Event 76657 | Landies Candies, Inc. | Food | Class I | 1 |
| 6 Mar 2017 | Miranda, 5 lb. wrapped in paper; Vulto Creamery, Walton, NY. | Tomales Bay Foods, Inc. | Food | Class I | 3 |
| 6 Mar 2017 | Assorted Bonbons are molded chocolates with ganache fillings in assorted flavors, No package weight. Product packaged in a black plastic tray and then tray is placed in a paper box with clear plastic lid. | Name withheld | Food | Class I | 26 |
| 4 Mar 2017 | Lake Fresh Whole Smoked Tilapia Net Wt 8 oz Capital Street LLC Old Bridge, NJ 08857 UPC 0680296079 Event 76651 | Capital Street LLC | Food | Class I | 1 |
| 3 Mar 2017 | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit. | Verathon Inc | Device | Class II | 1 |
| 3 Mar 2017 | The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 3 Mar 2017 | The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein. | Arrow International Inc | Device | Class II | 1 |
| 3 Mar 2017 | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application… | Covidien LLC | Device | Class II | 7 |
| 3 Mar 2017 | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and… | Cardiovascular Systems Inc | Device | Class II | 1 |
| 3 Mar 2017 | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 3 Mar 2017 | I.M. Healthy, Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025 | The SoyNut Butter Company | Food | Class I | 11 |
| 3 Mar 2017 | artisanal cheese VULTO Creamery HANDMADE CHEESE, Ouleout, NET WT. 2 lbs | Vulto Creamery | Food | Class I | 8 |
| 2 Mar 2017 | eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide… Event 76660 | Name withheld | Device | Class II | 1 |
| 1 Mar 2017 | Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx | Roche Diagnostics Corporation | Device | Class II | 2 |
| 1 Mar 2017 | Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609. Event 76714 | Signature Club A Ltd | Drug | Class II | 1 |
| 1 Mar 2017 | BRAISED BAMBOO SHOOT TIPS WITH CHILI, 10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10058 3 Companion Foods Corp. Taipei, Taiwan | Companion Foods Corp. | Food | Class III | 7 |
| 1 Mar 2017 | Parmesan Truffle Salt. The product is packaged in glass taster cork jars (0.9 oz.) with cork top lid, glass small jars (1.8 oz.) with glass lids, and glass large jars (6.1 oz.) with glass lids. Sold as single items. The label is read in parts: "***Parmesan Truffle Salt*** INGREDIENTS: SEA SALT, TRUFFLE, PARMIGIANO… Event 76640 | Name withheld | Food | Class II | 1 |
| 28 Feb 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525… | ConMed Corporation | Device | Class II | 5 |
| 28 Feb 2017 | The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION,… Event 76633 | Name withheld | Device | Class II | 1 |
| 27 Feb 2017 | MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 27 Feb 2017 | Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau,… | Welch Allyn Inc | Device | Class II | 1 |
| 27 Feb 2017 | Meijer Caesar Salad labeled as Meijer Greek Salad, Single serve salad, packed in plastic containers with printed labels, Keep Refrigerated | Meijer Inc | Food | Class II | 1 |
| 25 Feb 2017 | Hawaiian Delight, Net Wt. 4.5lb Event 76605 | Fuji Food Products, Inc. | Food | Class I | 1 |
| 24 Feb 2017 | BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 4 |
| 24 Feb 2017 | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | Philips North America, LLC | Device | Class I | 1 |
| 24 Feb 2017 | Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99 Event 76738 | Citron Pharma Llc | Drug | Class III | 1 |
| 24 Feb 2017 | 7-Eleven, Mantecada MUFFIN, Net Wt. 4 oz. , UPC 05254859241-7, in clear flexible plastic, Distributed by 7-Eleven, Inc., Irving, TX 750634. Event 76703 | Name withheld | Food | Class I | 1 |
| 24 Feb 2017 | Apple Juice 5 Gal, Keep Refrigerated, Ripe Liquid Produce | Freshbev LLC | Food | Class II | 4 |
| 23 Feb 2017 | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A). | Hill-Rom, Inc. | Device | Class II | 1 |
| 23 Feb 2017 | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 23 Feb 2017 | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck. Event 76501 | Streck | Device | Class II | 1 |
| 22 Feb 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and… Event 76595 | Name withheld | Device | Class I | 1 |
| 22 Feb 2017 | INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment. | Ace Surgical Supply Co., Inc. | Device | Class II | 1 |
| 22 Feb 2017 | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60 | Novel Laboratories, Inc. | Drug | Class III | 1 |
| 21 Feb 2017 | Two-Bite Pecan Tart 9.2 oz (261g) item number 02023; NL Two-Bite Pecan Tarts 24 x 9.2 oz (261g) item number 02046; Sweet P's Bake Shop Pecan Tarts NET WT 9.2 oz (261g) item number 13076 | Give and Go Prepared Foods Corp - Finch | Food | Class III | 4 |
| 21 Feb 2017 | Premo Turkey & Garlic Mayo Item # 207455, Net wt. 5.5 oz; Core-Mark Turkey & Garlic Mayo Item # 568207, Net wt. 5.5 oz; Fresh Grab Turkey & Provolone with Garlic Mayo Item # 455956, Net wt. 5.5 oz | Lipari Foods, Inc. | Food | Class I | 8 |
| 20 Feb 2017 | Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 | Signal Medical Corporation | Device | Class II | 1 |
| 20 Feb 2017 | SmartTools Knee System Orthopedic Stereotaxic Instrument | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |
| 20 Feb 2017 | La Fe Papa Criollas Yellow Potato Net Wt. 14 oz. Distributed: by La Fe Foods Moonachne, NJ 07074 UPC Event 76550 | Grace Kennedy Foods USA LLC | Food | Class II | 1 |
| 19 Feb 2017 | Cookies ASSORTI, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ). UPC: 8 51929 00358 6. The label is read in parts: "***COOKIES "ASSORTI" *** INGREDIENTS: WHEAT FLOUR, NIACIN, REDUCE IRON THIAMINE, MONONITRATE, RIBOFLAVIN, FOLIC ACID, BUTTER (PASTEURIZED CREAM, NATURAL FLAVORINGS, MILK),… | Kusher LLC | Food | Class I | 6 |
| 17 Feb 2017 | various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and,… | Zimmer Biomet, Inc. | Device | Class II | 6 |
| 17 Feb 2017 | Maggi 2 Minute Noodles, Net Wt. 19.75 oz., 2.46 oz. and 9.87 oz. Event 76559 | Classik Foods Inc. | Food | Class II | 1 |
| 17 Feb 2017 | Meijer Artisan Made Natural Muenster Cheese 8oz retail Plastic packaging Keep Refrigerated | Meijer Distribution, Inc | Food | Class I | 2 |
| 16 Feb 2017 | Cordis S.M.A.R.T. Flex Vascular Stent System | Cordis Corporation | Device | Class II | 1 |
| 16 Feb 2017 | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the… | Datascope Corporation | Device | Class II | 1 |
| 16 Feb 2017 | 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a… | Merit Medical Systems, Inc. | Device | Class I | 1 |
| 16 Feb 2017 | XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768 Event 76511 | Organic Herbal Supply | Drug | Class I | 1 |
| 16 Feb 2017 | GUGGISBERG NATURAL CHEESE COLBY INGREDIENTS: Pasteurized Milk, Cultures, Salt, Enzymes, Annatto Color 1 lb, 2 lb, 6 lb & 15 lb 11275 W 250 N MIDDLEBURY, IN 46540 | Dutch Valley Food Distributors | Food | Class I | 12 |
| 15 Feb 2017 | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. | Focus Diagnostics Inc | Device | Class II | 2 |
| 15 Feb 2017 | DELALLO Premium Sliced COLBY CHEESE NET WT. 8 OZ. (227G) INGREDIENTS: Cultured Pasteurized Milk, Salt, Enzymes, Annatto Color CONTAINS: MILK GEORGE DELALLO CO., INC., JEANNETTE, PA 15644 UPC 0 72368 12452 0 | Biery Cheese, Inc. | Food | Class I | 14 |
| 15 Feb 2017 | Great Midwest Applewood Smoked Gouda Cheese, approximately 6 lbs, keep refrigerated | Saputo Cheese USA, Inc. | Food | Class I | 2 |
| 14 Feb 2017 | Good Plenty Brand Supreme Abalone Noodles, 21.2 oz. box. Each box contains Retort pouch of Noodles and Abalone. These two pouches are packed together in the box; 10 boxes per case. Event 76705 | Lian Hwa Foods (USA) Inc. | Food | Class III | 1 |
| 13 Feb 2017 | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and… | Beckman Coulter Inc. | Device | Class II | 1 |
| 10 Feb 2017 | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial. | United Orthopedic Corporation | Device | Class II | 1 |
| 10 Feb 2017 | Meijer Colby and Colby Jack Deli Cheese 6lb horn; sold from the Meijer store Deli counter, by weight Sold in plastic deli packaging with printed labels | Meijer Distribution, Inc | Food | Class I | 1 |
| 9 Feb 2017 | SynchroMed II implantable drug infusion pump, Model 8637-40, Event 76591 | Name withheld | Device | Class II | 1 |
| 9 Feb 2017 | Copper wood Colby Jack Mini Horn, 4/6# | Lipari Foods, Inc. | Food | Class I | 14 |
| 8 Feb 2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. | X-Gen Pharmaceuticals Inc. | Drug | Class I | 1 |
| 3 Feb 2017 | Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40 | SCA Pharmaceuticals | Drug | Class I | 7 |
| 2 Feb 2017 | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493 | CP Medical Inc | Device | Class II | 1 |
| 2 Feb 2017 | Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. Event 76446 | Elcam Medical, Inc. | Device | Class II | 1 |
| 2 Feb 2017 | Ruth'’s Original Pimento Spread 7oz (UPC 74952-0005), 12oz (UPC 74952-12023) and 24oz (74952-24023), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers. | B & H Foods Inc | Food | Class I | 5 |
| 1 Feb 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN… | Respironics California Inc | Device | Class II | 1 |
| 27 Jan 2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment. | National Biological Corp | Device | Class II | 1 |
| 27 Jan 2017 | Schlabach Amish Bakery Chocolate Chip Grand-ola Bar NET WT. 2.8 OZ (80g) UPC 0 14757 13000 2 Contains: Wheat, Tree Nuts, Dairy Ingredients: Oats, chocolate chips (sugar,chocolate liquor, cocoa butter, whole milk, lecithin [an emulsifier], salt, vanilla), brown sugar, wheat, corn syrup***walnuts, soda, vanilla… Event 76741 | Original Amish Bakery LLC | Food | Class II | 1 |
| 26 Jan 2017 | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V. Event 76384 | Name withheld | Device | Class II | 1 |
| 26 Jan 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 24 Jan 2017 | Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01 | Hospira Inc., A Pfizer Company | Drug | Class I | 1 |
| 23 Jan 2017 | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma. Event 76697 | Strata Skin Sciences, Inc. | Device | Class II | 1 |
| 18 Jan 2017 | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 13 Jan 2017 | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 1 |
| 9 Jan 2017 | Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland | Resource Optimization & Innovation Llc | Device | Class II | 135 |
| 8 Jan 2017 | Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA… | Laerdal Medical Corporation | Device | Class II | 1 |
| 7 Jan 2017 | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30 | Hetero USA Inc | Drug | Class III | 1 |
| 5 Jan 2017 | Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284 | InnovaGel | Drug | Class III | 2 |
| 30 Dec 2016 | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions | Hospira Inc., A Pfizer Company | Device | Class II | 1 |
| 19 Dec 2016 | Buffalo Blue Kettle Cooked Potato Chips 8 oz (227g) Event 76019 | Pinnacle Foods | Food | Class II | 1 |
| 13 Dec 2016 | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN) | Boston Scientific Corporation | Device | Class II | 1 |
| 9 Dec 2016 | QUIK 'N CREAMY VANILLA POWDERED FILLING Item number 00014100 25 pound bag | Dawn Food Products Inc. | Food | Class I | 5 |
| 7 Dec 2016 | Oriental Jamaican Hot Curry Powder, 50 lb bulk. Manufactured by Oriental Packing Co. | Oriental Packing Co., Inc. | Food | Class I | 4 |
| 7 Nov 2016 | Gourmet Kitchen Gourmet/Stuffed/French Toast with Strawberries & Mascarpone 20 PCS 1238 Corlies Avenue Neptune, NJ 07753 gourmetkitcheninc.com | Gourmet Kitchen, Inc. | Food | Class I | 1 |
| 20 Oct 2016 | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide Event 75890 | Micromedics, Inc. | Device | Class II | 1 |
| 19 Oct 2016 | 100% APPLE CIDER 1 Gallon (3.78L) UV TESTED KEEP REFRIGERATED UPC 0 85591 00128 1 Event 75515 | Myers Cider Mill, LLC | Food | Class II | 1 |
| 17 Oct 2016 | Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Sep 2016 | Sammy's Milk (Baby Food), Net Wt. 12.84 oz (364 g), 6 containers per case Event 75333 | Name withheld | Food | Class I | 1 |
| 29 Sep 2016 | 8500M Handheld Pulse Oximeter Event 75424 | Nonin Medical, Inc | Device | Class II | 1 |
| 22 Sep 2016 | Truco 1 50/50 Corn Masa Flour 50 lb bags & totes | Azteca Milling LP | Food | Class II | 5 |
| 2 Sep 2016 | Asher's Chocolate Co, Milk Chocolate (11481) Pretzel Cluster; Net Wt. 5 lb.; Asher's Chocolate Co, Milk Chocolate (75261) Pretzel Cluster; 4 oz. (12/box). | Ashers Chocolates/Lewistown, Inc. | Food | Class I | 87 |
| 1 Aug 2016 | The product is packaged in a white plastic bottle with green lettering. The label reads in part "LIFE RISING DHZC-2, blood circulation regulator (lower abdomen), Chinese Herbal Supplement, 60 tablets, life rising to higher well being", UPC: 616042102727 | Life Rising Corp S | Food | Class I | 1 |
| 9 Jun 2016 | Dark Chocolate bars Choklad Mork Dark Chocolate, Net Wt. 3.5 OZ. AND Chokland Mork Dark Chocolate 70%, Net Wt. 3.5 OZ. Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden. | Ikea North America Srvcs Inc | Food | Class II | 6 |
| 7 Jun 2016 | Luqman Cheese, Monterey Jack, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Monterey Jack Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055 | Cumberland Valley Creamery, LLC | Food | Class II | 29 |
| 2 May 2016 | DX-D600 - DXD Imaging Package | AGFA Healthcare Corp. | Device | Class II | 1 |
| 15 Apr 2016 | Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps | 2k Innovations Inc. | Device | Class II | 12 |
| 8 Apr 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 3 |
| 4 Apr 2016 | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Eye Station and Merge Eye Care PACS. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | iConnect Enterprise Archive software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 28 Mar 2016 | NuGo Slim Crunchy Peanut Butter Protein Bar, 5g net carbs, A gluten-free, soy protein bar with overall peanut butter and chocolate taste covered in dark chocolate, Best Buy 07/28/2017, manufactured for: NuGo Nutrition 520 second Street, Oakmont, PA 15139 INGREDIENTS: SLIM PROTEIN [NON-GMO SOY CRISP (NON-GMO SOY… | NuGo Nutrition HQ | Food | Class I | 1 |
| 20 Jan 2016 | AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis | AGFA Healthcare Corp. | Device | Class II | 1 |
| 14 Dec 2015 | BD Viper LT software, version 3.00H Event 76895 | Name withheld | Device | Class II | 1 |
| 7 Dec 2015 | Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 23 Oct 2015 | Sunrise Brand Marinated Silver/White Croaker - 30 x 14oz, Item No. C0081, UPC 5 08 54336-50081 0 | SEAQUEST SEAFOOD CORPORATION | Food | Class I | 6 |
| 21 Oct 2015 | DH. ANCHOVY 2.2 Lbs.; Item No: D0161; B/C: 59033 50161; DH. ANCHOVY 3.5 oz..; Item No: D0162; B/C: 59033 50162 Event 72473 | Seafood Avenue | Food | Class I | 1 |
| 27 Aug 2015 | Baidyanath brand Sarivadi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006 | Butala Emporium, Inc. | Food | Class I | 10 |
| 29 Jul 2015 | Software version 4.44A utilized on the BD MAX System Event 76900 | BD LIFE SCIENCES | Device | Class II | 1 |
| 17 Jun 2015 | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in… | Agilent Technologies, Inc. | Device | Class II | 1 |
| 20 Jan 2015 | Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer. | Molded Products Inc | Device | Class II | 1 |
| 23 Oct 2014 | JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results,… | Data Innovations, LLC | Device | Class II | 1 |
| 11 Jun 2014 | Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal… Event 76763 | Hitachi Aloka Medical, Ltd. | Device | Class II | 1 |
| 18 Feb 2013 | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations. Event 64545 | Ge Medical Systems Information T | Device | Class II | 1 |
| 28 Nov 2012 | Mobile Diagnostic X-Ray System with Digital Panel | Philips Healthcare Inc. | Device | Class II | 1 |