| 9 Sep 2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59 | West-Ward Columbus Inc | Drug | Class II | 1 |
| 9 Sep 2019 | MiCal brand YELLOWFIN TUNA POKE CUBE, Raw, Frozen, Product of Vietnam, Wild Caught. Cube size - 1 inch (2cm x 2cm) AAA grade. Product is packed in 1lb vacuum packed bags in a pre-printed labeled master case. Master case weight is 5lbs. Event 83756 | Stavis Seafoods, Inc. | Food | Class II | 1 |
| 6 Sep 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01. | Torrent Pharma Inc. | Drug | Class II | 1 |
| 6 Sep 2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 | Pfizer Inc. | Drug | Class II | 1 |
| 6 Sep 2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 6 Sep 2019 | MDH Sambar Masala; Spices blend for South Indian Cuisine 3.5 oz. (100 g) box. code 6291103750327 Ingredients: coriander, Chili Rec, Cumin Powder, Tumeric, Salt White, Fenugreek seeds, Mustard, Lentil (Chana Dal) Lentil (Pigeon peas lentil) Black Pepper, Fennel, Cassia, Cloves, Curry leaves, Nutmeg, Fenugreek Leaves,… | House of Spices India, Inc. | Food | Class II | 1 |
| 4 Sep 2019 | Ore Ida Spud Bites, packaged in 5lb. plain poly foodservice bags, six bags per case, frozen, Case UPC: 1 00 72714 00093 2. SKU: OIF00093A | McCain Foods USA | Food | Class II | 1 |
| 3 Sep 2019 | 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. | Compounded Solutions in Pharmacy | Drug | Class II | 3 |
| 30 Aug 2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | Plastikon Healthcare LLC | Drug | Class I | 1 |
| 30 Aug 2019 | Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 | Pacifico National, Inc. dba AmEx Pharmacy | Drug | Class II | 2 |
| 30 Aug 2019 | One-Half Gallon Hiland Dairy Lemonade UPC: 72060-00519-6 packaged in plastic bottle and Pint Hiland Dairy Lemonade UPC: 72060-00524-0 packaged in plastic bottle Event 83690 | Hiland Dairy Foods | Food | Class I | 1 |
| 30 Aug 2019 | Glazed Pumpkin Cake Donut, 49226, UPC 10020569492266, NET WEIGHT 9.00 LB (4.08 kg), 12/12 OZ PKG PER CASE | WESTON FOODS (CANADA) INC | Food | Class II | 3 |
| 30 Aug 2019 | YoCrunch VANILLA LOWFAT YOGURT WITH SNICKERS PIECES 4 - 4 oz (113g) - 16 oz (453g) 6 packaged or 4 cups per case. UPC 46675 01326 Event 83691 | Danone Waters of America, Inc | Food | Class II | 1 |
| 30 Aug 2019 | Cena Vegan Pollo Asado Plant-Based Meat; Net Wt. 16 oz. (448 grams) retail, Net Wt. 5 lb. - food service; UPC: 8 55687 00701 5; Ingredient: Vital wheat gluten, Garbanzo bean flour, Vegetable bouillon, Orange juice, Less than 2% of: Vegetable Oil, Lime Juice, Onion Powder, Garlic Powder, Garlic, Paprika, Cumin,… Event 83723 | Name withheld | Food | Class II | 1 |
| 30 Aug 2019 | Sea Cuisine Asian Grill Rubbed Salmon. Two Atlantic Salmon fillets with garlic, ginger, soy sauce & chiles; NET WT 8 OZ (227 g); KEEP FROZEN; Cooking instructions included - " be sure to cook to a minimum temperature of 165F before enjoying" | High Liner Foods Inc. | Food | Class II | 2 |
| 28 Aug 2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50. | AVKARE Inc. | Drug | Class II | 1 |
| 28 Aug 2019 | Plastic Bottles labeled with: "Ancient Youth Secret - Since 500 B.C., DR. NARAM'S RASAYANA D TABLET, Calcium Supplement with Vitamin D*, Dietary Supplement, 60 Tablets, FOR EXPORT ONLY, Imported & Distributed by: Jivan Shakti INC, 933 South Street, Peekskill, NY 10566, Manufactured by: Reve Pharma, Plot No-78, STICE,… Event 83631 | Jivan Shakti Inc. | Food | Class III | 1 |
| 28 Aug 2019 | El Monterey XXL Bean and Cheese Burrito; 9.5 oz. frozen burrito in film Microwaveable Case UPC: UPC 1 00 71007 06217 6; Sell unit UPC: 0 71007 06217 9 Event 83663 | Ruiz Food Products Inc | Food | Class II | 1 |
| 27 Aug 2019 | AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 27 Aug 2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH | American Health Packaging | Drug | Class III | 1 |
| 27 Aug 2019 | Savory Tuna salad 16 oz. packaged in Clear PP containers UPC 4122033749 Event 83666 | BAKKAVOR USA | Food | Class II | 1 |
| 26 Aug 2019 | Nice! Espresso Trail Mix, Net Wt 2.5 Oz (70g) Pouch. Distributed by Sun Tree Snack Foods, LLC, Ambient Storage | Suntree Snack Foods, LLC | Food | Class II | 1 |
| 26 Aug 2019 | PediaSmart Organic Soy Vanilla Beverage Mix, 12.7 oz. (360g) composite can Event 83643 | Natures One Inc | Food | Class II | 1 |
| 26 Aug 2019 | Martha White Gluten Free Sweet Yellow Cornbread & Muffin Mix packaged in a 7oz. pouch. 12 pouches per wholesale case. Item UPC: 0 1330082014 8. | Hometown Food Company | Food | Class II | 1 |
| 23 Aug 2019 | Monaco Radiation Treatment Planning System (RTP) System | Elekta, Inc. | Device | Class II | 1 |
| 23 Aug 2019 | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to… | Philips North America, LLC | Device | Class II | 1 |
| 23 Aug 2019 | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21 | Aurolife Pharma, LLC | Drug | Class II | 11 |
| 23 Aug 2019 | Coconut Macaroons "Besitos de Coco" packaged in 6 oz. clamshell containers with brand name La Orocovena Biscuit. Event 83638 | La Orocovena Biscuit de PR, Inc. | Food | Class II | 1 |
| 23 Aug 2019 | TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE were distributed nationwide in retail stores and through mail orders. The product comes in 500gram (17.65 oz), clear plastic package marked with container code #15 03 2019 SS. The text on the label is written in Russian. | Krasnyi Oktyabr Inc. USA | Food | Class I | 2 |
| 22 Aug 2019 | QQ Fish brand Mushroom Fish Ball, 200g | Great One Trading Inc. | Food | Class I | 5 |
| 21 Aug 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator | Boston Scientific Corporation | Device | Class II | 2 |
| 21 Aug 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10 | Macleods Pharma Usa Inc | Drug | Class III | 1 |
| 21 Aug 2019 | FungusAmongUs Shiitake Organic Mushrooms are dried mushrooms. Packaged in a clear cellophane bag, net Weight 1 ounce. UPC 7 19870 60023 3 for individual 1 ounce bags UPC 50719870600016 for Master caddy that holds 8 packages of 1 ounce bags The label is read in parts: "***Organically Grown Shiitake Mushrooms… Event 83611 | Seattle Gourmet Foods Inc. | Food | Class III | 1 |
| 21 Aug 2019 | Stonyfield Kids Strawberry Beet Berry Tubes, 8 count-2oz each; 453g/package; Keep Refrigerated Event 83609 | Name withheld | Food | Class II | 1 |
| 20 Aug 2019 | Maple Iced Cinnamon Rolls, Net Wt. 1.33 lbs., Walnuts on top in see-through clamshells with clear plastic lids. 8 rolls per clamshell. Event 83605 | Schrock's Sugar 'N Spice LLC | Food | Class II | 1 |
| 20 Aug 2019 | All colors and sizes of Confectionery Arts International, LLC brand Jewel Dust, a pearlescent pigment, manufactured and sold prior to 4/25/19; 4g packed in 1/4 oz. jars and 14g packed in 1 oz. jars. Event 83588 | Confectionery Arts International, LLC | Food | Class II | 1 |
| 19 Aug 2019 | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures. | CooperSurgical, Inc. | Device | Class III | 1 |
| 19 Aug 2019 | Bubbies Cookie Dough Ice Cream Bites - Brownie Batter, Item Code CDR00003, UPC 50012-4, UPC GTIN 10787325500121. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes. | Bubbies Homemade Ice Cream and Desserts, Inc. | Food | Class II | 22 |
| 16 Aug 2019 | Diet Mountain Dew (Dewnited Michigan) 20 oz. plastic bottle Promotional give away as individual units | Pepsico Inc | Food | Class II | 1 |
| 16 Aug 2019 | Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton. Event 83608 | Abbott Nutrition, Division of Abbott Laboratories | Food | Class II | 1 |
| 16 Aug 2019 | Ground Cinnamon 4oz plastic container 24 containers per wholesale case Event 83543 | Kashat Wholesale, Inc. | Food | Class II | 1 |
| 15 Aug 2019 | XP- CR Tibial Tray- Interlok 59mm Item # 195268 | Zimmer Biomet, Inc. | Device | Class II | 35 |
| 15 Aug 2019 | Grained Salmon Caviar 95g (Sockeye Salmon Caviar), refrigerated, packed in a metal tin with Cyrillic lettering. The tin is green, with red and white writing with an easy open pull lid. UPC 8 85202 00044 3. The label is read in parts: "***GRAINED SALMON CAVIAR ***INGREDIENTS: RED SALMON (FISH) ROE, SALT, SORBIC ACID… Event 83585 | AWERS Inc | Food | Class II | 1 |
| 14 Aug 2019 | RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017. | Pfizer Inc. | Drug | Class II | 1 |
| 12 Aug 2019 | Red Bean bread package contains two bread pastries filled with red bean paste filling, packaged in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and reads in part: ***Olive bakery ***Ingredients: Red bean… | Olive Bakery | Food | Class II | 12 |
| 9 Aug 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline | Medline Industries Inc | Device | Class II | 1 |
| 9 Aug 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. | Ridge Properties, LLC | Drug | Class II | 6 |
| 9 Aug 2019 | 365 Organic Maple & Brown Sugar Pecan Instant Oatmeal 2.3 oz (65 g) microwaveable cups that are sold individually | Whole Foods Market | Food | Class II | 1 |
| 9 Aug 2019 | Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G) | Vitony Bakery, Inc. | Food | Class II | 3 |
| 9 Aug 2019 | Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 and 0 480000 11817 7 individual pouch; UPC 1 00 48000 01179 1 - Case Chicken of the Sea International El Segundo, CA Product of Thailand. | Tri-Union Frozen Products, Inc. | Food | Class II | 2 |
| 8 Aug 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles.… | Alkermes Inc | Drug | Class II | 1 |
| 7 Aug 2019 | Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 7 Aug 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. | Aesculap Implant Systems LLC | Device | Class II | 2 |
| 7 Aug 2019 | Sweet Basil Farm Hawaii Event 83550 | Name withheld | Food | Class II | 1 |
| 6 Aug 2019 | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker. | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 2 |
| 6 Aug 2019 | Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90. | Akorn, Inc. | Drug | Class III | 3 |
| 5 Aug 2019 | Martin's 8 Sandwich POTATO ROLLS NET WT. 15oz (425 GRAMS) plastic bag MARTIN'S PASTRY SHOPPE, INC. 1000 Potato Roll Lane Chambersburg, PA 17202-8897 UPC 0 75185 00003 9 Event 83506 | Martin's Famous Pastry Shoppe, Inc. | Food | Class II | 1 |
| 2 Aug 2019 | Lipton DIET ICED TEA PEACH 6/16.9 oz plastic bottles MANUFACTURED BY INDEPENDENT PRODUCERS FOR THE PEPSI/LIPTON TEA PARTNERSHIP, PURCHASE, NY 10577 Event 83493 | Pepsi Bottling Ventures, LLC | Food | Class III | 1 |
| 2 Aug 2019 | PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc., 4450 Fortune Ave. NW Concord, NC… Event 83483 | PreGel America, Inc. | Food | Class II | 1 |
| 1 Aug 2019 | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008 | Becton Dickinson & Company | Device | Class II | 1 |
| 1 Aug 2019 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. Event 83510 | Name withheld | Device | Class II | 1 |
| 31 Jul 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90… | Haag-Streit USA Inc | Device | Class II | 3 |
| 31 Jul 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data | Siemens Medical Solutions USA, Inc | Device | Class II | 7 |
| 30 Jul 2019 | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281;… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Jul 2019 | Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management | Teleflex Medical | Device | Class I | 8 |
| 29 Jul 2019 | Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 | Aurobindo Pharma USA Inc. | Drug | Class III | 1 |
| 27 Jul 2019 | Fresh basil packaged in plastic bags, each weighing one pound. (No label) Event 83484 | Harvest Sensations, LLC | Food | Class I | 1 |
| 26 Jul 2019 | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 | Becton Dickinson & Co. | Device | Class II | 2 |
| 25 Jul 2019 | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Jul 2019 | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus. | Stryker GmbH | Device | Class II | 13 |
| 25 Jul 2019 | Diges-Teas Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05665 2. The label is read in parts: "***Diges-Teas ***CAFFEINE-FREE HERBAL TEA*** Mountain Mels Essential Goods, LLC Welches, OR 97067***Supplement Facts***Fennel*** Directions: Drink 1-4 cups daily with meals or… | Mountain Mel's Essential Goods LLC | Food | Class I | 3 |
| 24 Jul 2019 | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the… | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 24 Jul 2019 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical Inc. | Device | Class II | 1 |
| 24 Jul 2019 | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Exactech, Inc. | Device | Class II | 1 |
| 24 Jul 2019 | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style… | Allergan PLC | Device | Class I | 15 |
| 23 Jul 2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328 | OMNIlife science Inc. | Device | Class II | 3 |
| 23 Jul 2019 | ROTEM ex-tem; US Part No: 503-05-US | Instrumentation Laboratory Co. | Device | Class II | 3 |
| 22 Jul 2019 | Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. | GETINGE US SALES LLC | Device | Class II | 1 |
| 22 Jul 2019 | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS… | Zeus Scientific, Inc. | Device | Class II | 1 |
| 19 Jul 2019 | Fujifilm FDR Go Plus mobile X-ray system | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 19 Jul 2019 | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161 | Boston Scientific Corporation | Device | Class II | 1 |
| 19 Jul 2019 | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F Event 83396 | Coltene /Whaledent AG | Device | Class II | 1 |
| 19 Jul 2019 | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration | Philips North America, LLC | Device | Class II | 1 |
| 18 Jul 2019 | cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 | Roche Diagnostics Operations, Inc. | Device | Class II | 3 |
| 16 Jul 2019 | Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 16 Jul 2019 | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed… | Philips North America, LLC | Device | Class II | 1 |
| 15 Jul 2019 | Bucee's Garlic Hummus with Pretzels 4.1 oz UPC 850157000312 packaged in Plastic tub with clear lid. | Pita Pal Foods LP | Food | Class I | 71 |
| 12 Jul 2019 | This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide… | Randox Laboratories Ltd. | Device | Class III | 1 |
| 11 Jul 2019 | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 11 Jul 2019 | Dolce Piquant Sweet and Sour 3 gallon (384 Fl OZ) and Freshmo Sweet and Sour in 3 gallon (384 Fl OZ) | Southern Style Mfg | Food | Class II | 2 |
| 10 Jul 2019 | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 | B. Braun Medical, Inc. | Device | Class II | 9 |
| 9 Jul 2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. | Phadia Ab | Device | Class II | 1 |
| 8 Jul 2019 | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less.… | CooperSurgical, Inc. | Device | Class II | 1 |
| 3 Jul 2019 | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. Event 83568 | Heidelberg Engineering GmbH | Device | Class II | 1 |
| 2 Jul 2019 | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 1 Jul 2019 | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 | CareFusion 303, Inc. | Device | Class II | 1 |
| 27 Jun 2019 | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012 | Angiodynamics, Inc. | Device | Class II | 1 |
| 27 Jun 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500 | Baxter Healthcare Corporation | Device | Class III | 1 |
| 20 Jun 2019 | Norm-O-Temp model 111Z | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Device | Class II | 2 |
| 18 Jun 2019 | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes | Ad-Tech Medical Instrument Corporation | Device | Class II | 3 |
| 10 Jun 2019 | Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 6 Jun 2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic | DRG Instruments GmbH | Device | Class II | 1 |
| 31 May 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799 | Bard Peripheral Vascular Inc | Device | Class II | 28 |
| 29 May 2019 | Quantum Pump Console | Spectrum Medical Ltd. | Device | Class I | 1 |
| 23 May 2019 | DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility Event 83017 | Name withheld | Device | Class II | 1 |
| 24 Apr 2019 | Flexible Intubation Fiberscope, Model # 11301AB1 Event 83419 | Name withheld | Device | Class II | 1 |
| 16 Apr 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation… | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 16 Apr 2019 | EyeBOX Model OCL 02 Event 82922 | OCULOGICA | Device | Class II | 1 |
| 22 Mar 2019 | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes… | Name withheld | Device | Class II | 2 |
| 20 Feb 2019 | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 Event 83459 | Name withheld | Device | Class II | 1 |
| 15 Feb 2019 | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the… | Alere San Diego, Inc. | Device | Class II | 1 |
| 15 Aug 2018 | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the… | Agilent Technologies, Inc. | Device | Class II | 1 |
| 15 Jan 2018 | LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 17 Apr 2017 | SonarMed AirWave Monitor, Model Number M0001 | SonarMed Inc | Device | Class II | 1 |
| 14 Oct 2016 | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Helena Laboratories, Inc. | Device | Class II | 1 |
| 11 Jul 2016 | Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures. | Bausch & Lomb Inc Irb | Device | Class II | 2 |