| 19 Nov 2019 | 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 12 Nov 2019 | Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. | Integrated Health Concepts Inc. dba Conversio Health | Drug | Class II | 10 |
| 12 Nov 2019 | Simplot simple goodness Classic Mixed Vegetables, foodservice item. There are 12/2.5 lbs. clear plastic bags per case. SKU #: 10071179 188117. The label of 2.5 lbs. bag is read in parts: "***Simplot simple goodness ***MIXED VEGETABLES GRADE A*** INGREDIENTS: CARROTS, CORN, GREEN BEANS, PEAS, LIMA BEANS *** NET WT 40… (84269) | SIMPLOT-RDO LLC | Food | Class I | 1 |
| 9 Nov 2019 | Sushi grade yellowfin tuna individually wrapped in various product weights. | International Marine Products Inc. Houston | Food | Class I | 3 |
| 8 Nov 2019 | Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0. | Washington Homeopathic Products, Inc. | Drug | Class II | 16 |
| 6 Nov 2019 | GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. | Golden State Medical Supply Inc. | Drug | Class II | 2 |
| 5 Nov 2019 | Dry dates packaged under the following brands: Keshav Dry Yellow Dates, 7oz., UPC: 643864233124 and 14oz., UPC: 643864233131; and Swan Dry Yellow Dates, 7 oz., UPC: 643864136623 and 14oz., UPC: 643864136630. Product is in a clear plastic pouch (or explain the packaging). (84225) | Peekay International, Inc. | Food | Class I | 1 |
| 5 Nov 2019 | Tomato, Carrot, Broccoli & Snap Pea- 13 oz in clear plastic container. Brands: Crazy Fresh, Quick&Easy, or Plain Label | Russ Davis Wholesale, Inc. | Food | Class I | 17 |
| 4 Nov 2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 4 Nov 2019 | Winter Citrus Slaw Kit, item #71909, UPC 20728 71909. There are 2/7.2 lbs. bags of multiple ingredients per kit. Each kit contains multiple products and 4/12 oz. bags of Mann Packing Broccoli Cole Slaw: -Mann Packing Broccoli Cole Slaw (4/12 oz bags). -Bacon pieces -Red onion, diced (DM). -Kale, chopped (GF).… | Pacific Coast Fruit Company | Food | Class I | 1 |
| 3 Nov 2019 | Del Monte brand Better Break Zesty Green Chili; Vegetables in a Fresh and Tangy Green Chili Sauce. UPC 717524671028 7 oz. container 6 x 7 oz. per carton | Mann Packing Company, Inc. | Food | Class I | 58 |
| 1 Nov 2019 | Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16 | KVK-Tech, Inc. | Drug | Class II | 1 |
| 1 Nov 2019 | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02 | Lupin Pharmaceuticals Inc. | Drug | Class III | 3 |
| 30 Oct 2019 | Season's Choice Raspberries (frozen): 12 ounce bags; Product of Chile. Item number: 076163-01 Aldi brand name Season's Choice UPC Code: 0 41498 12419 9; Raley's Fresh Frozen Red Raspberries: 12 ounce bags; Product of Chile; Item number:072930-20 UPC Code: 46567 00754 | Wawona Frozen Foods Inc. | Food | Class I | 2 |
| 30 Oct 2019 | Tony's Columbia Gorge Salmon, Skinless and boneless salmon, packaged in a metal can, Net Wt. 6.5 oz./184g. The label reads in parts: "*** Columbia Gorge Salmon *** Ingredients: Salmon and Salt ***TONY'S SMOKEHOUSE AND CANNERY 1316 Washington Street Oregon City, OR 97045 United States of America***". (84181) | Tonys Smoke House and Cannery Inc | Food | Class II | 1 |
| 29 Oct 2019 | Market Choice Monster Cheeseburger, Net Wt. 9.1 oz individually wrapped in plastic, packaged 12 count per case. | Pride of Iowa Sandwiches, Inc. | Food | Class II | 4 |
| 28 Oct 2019 | Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80 | Lannett Company, Inc. | Drug | Class II | 1 |
| 28 Oct 2019 | TEMPLE PURE PRANA MATCHA+SHOT; 3 FL OZ (89mL); VITALITY SUPERBOOST; COLD PRESSURED; PERISHABLE KEEP REFRIGERATED; plastic bottles in 12 pack or 24 pack; UPC 8-54351-00547-0 (84248) | Temple Turmeric Inc. | Food | Class II | 1 |
| 25 Oct 2019 | Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy… (84120) | Galil Medical, Inc. | Device | Class II | 1 |
| 25 Oct 2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03 | ICU Medical Inc | Drug | Class I | 2 |
| 25 Oct 2019 | Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20 | Novitium Pharma LLC | Drug | Class II | 4 |
| 24 Oct 2019 | Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955 | Centurion Medical Products Corporation | Device | Class II | 1 |
| 23 Oct 2019 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 23 Oct 2019 | Parivar brand Dry Dates (Kharek) Net Wt.7 oz. (200 g) and 14 oz. (400 g) Product of India Batch No. 125/BIBT (84116) | DILIP CERAMICS DBA SHIVAM DISTRIBUT | Food | Class I | 1 |
| 23 Oct 2019 | Frozen Ika Popo (Sugata Yaki); Product # 51106 16 pkg/0.46 lbs (210g)/case | Azuma Foods International Inc USA | Food | Class I | 4 |
| 22 Oct 2019 | EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 22 Oct 2019 | Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8 | Apotex Inc. | Drug | Class III | 1 |
| 22 Oct 2019 | Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513,… | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 22 Oct 2019 | Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622. (84105) | Green Lumber Holdings, LLC | Drug | Class I | 1 |
| 21 Oct 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques. | Cook Inc. | Device | Class II | 71 |
| 21 Oct 2019 | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10. | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center | Drug | Class III | 1 |
| 21 Oct 2019 | Fire Roasted Medium Arriba! Bacon Salsa with Real Bacon NET WT 16 OZ. UPC Code: 033907 20513 1 packaged in a clear glass jar | Riba Foods Inc | Food | Class II | 1 |
| 18 Oct 2019 | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598… | Tornier, Inc | Device | Class II | 1 |
| 18 Oct 2019 | Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B) | Basic Reset Inc. | Device | Class II | 1 |
| 18 Oct 2019 | Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075. | Basic Reset Inc. | Drug | Class II | 11 |
| 18 Oct 2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 18 Oct 2019 | Kroger Wild Caught Sockeye Salmon Boneless, Frozen, Raw, Skin-on, not ready to eat (NRTE), individually vacuum packed in a 12 oz retail plastic bag. Salmon is a product of USA. The label is read in parts: "***Kroger ***Wild Caught Sockeye Salmon Boneless***INGREDIENTS: SOCKEYE SALMON ***COOKING… (84083) | Cold Locker Processing LLC | Food | Class II | 1 |
| 18 Oct 2019 | Arroyo Grande California Cilantro; Talley Farms; Product of USA - 30 or 60 Count Individual bunches tied with Talley Farms Arroyo Grande twist tie. (84079) | Talley Farms | Food | Class II | 1 |
| 17 Oct 2019 | Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina. | Sandoz Inc | Drug | Class III | 3 |
| 17 Oct 2019 | AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | AVKARE Inc. | Drug | Class II | 2 |
| 17 Oct 2019 | Harris Teeter PREMIUM SELECTIONS CHOCOLATE SATISFACTION ICE CREAM 1.5 QT (1.42L) container PROUDLY DISTRIBUTED BY: HARRIS TEETER. LLC, MATTHEWS, NC 28105 UPC 0 72036 43030 4 | Harris Teeter Supermarkets, LLC dba Hunter Farms | Food | Class II | 4 |
| 16 Oct 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Philips North America, LLC | Device | Class II | 1 |
| 16 Oct 2019 | Hitachi Scenaria Whole-body X-ray CT System | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 16 Oct 2019 | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 | Amneal Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 16 Oct 2019 | Food Lion Creamy Chocolate Frosting, Net Wt 16 OZ, Distributed by Food Lion, LLC, Salisbury, NC, foodlion.com, packaged in 12 cans per case. | Gilster-Mary Lee Corp. | Food | Class II | 1 |
| 16 Oct 2019 | Dr. Pepper 24 pack of 12 FL OZ Cans (288 FL OZ) in cardboard cases: Produced under the authority of Dr. Pepper/Seven Up, Inc., 5301 Legacy Drive, Plano, TX 75024; Best Before: JUN 29 20; Case UPC: 078000082104; Can UPC: 07831504 (84069) | Epic Enterprises, Incorporated | Food | Class III | 1 |
| 15 Oct 2019 | Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41. | 8046255 Canada Inc. DBA Viatrexx | Drug | Class II | 23 |
| 15 Oct 2019 | Full Moon Fish Tuna Steaks, Skinless, Boneless, IVP, Size: 8 oz, Net Weight 5 lbs (84074) | ALFA INTERNATIONAL SEAFOOD INC | Food | Class II | 1 |
| 15 Oct 2019 | Disney Donald Duck Kiwi Strawberry Flavored Four Juice Cocktail 20 OZ (84056) | Citrus World, Inc. | Food | Class II | 1 |
| 15 Oct 2019 | Bulk Dry Apricot in clear plastic bags inside brown cardboard box and Swan brand Dry Appricot & Keshav brand Dry Apricot in 7oz and 14oz clear plastic bags. Imported & Distributed By: Peekay International Inc. 56-12 56th Street, Maspeth, New York - 11378. U.S.A. Keshav 7oz UPC: 4386423302 Keshav 14oz UPC: 4386423303… (84053) | Peekay International, Inc. | Food | Class I | 1 |
| 14 Oct 2019 | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 | Becton Dickinson & Company | Device | Class II | 2 |
| 14 Oct 2019 | NATHAN'S COLD SMOKED WILD SALMON, in 3oz.vacuum packed pouch, 12 units per wholesale case, UPC 73030 80686 | Vita Food Products, Inc. | Food | Class I | 1 |
| 11 Oct 2019 | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to… (84134) | Nucryo Vascular Inc. | Device | Class II | 1 |
| 11 Oct 2019 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | AMD Medicom Inc. | Device | Class II | 2 |
| 11 Oct 2019 | Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1 | X-Gen Pharmaceuticals Inc. | Drug | Class III | 1 |
| 11 Oct 2019 | Trade Winds Premium Grade Yellowfin (Ahi) Tuna Ground Keep Frozen Net Weight 10 LBS. (4.54 KG) Product of Vietnam Specifically Packed For: Relish Foods, Inc. 5840 Uplander Way #201 Culver City, CA 90230 (84048) | Relish Foods, Inc. dba Gourmet Fusion Foods, Inc. | Food | Class II | 1 |
| 10 Oct 2019 | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813… | Zimmer Biomet, Inc. | Device | Class II | 41 |
| 10 Oct 2019 | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Innoveix Pharmaceuticals Inc | Drug | Class II | 4 |
| 10 Oct 2019 | Sweet Smiles brand Select Dark Chocolate with Orange Peel Bar in 3.5 oz. foil wrapper packaging. | Dollar General Corporation | Food | Class II | 1 |
| 9 Oct 2019 | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 9 Oct 2019 | Whole Foods Market White Parkerhouse Rolls PLU 49557 NET WT. 0 lb 12 oz (340g) packaged in a clear plastic bag 12 rolls per bag | Whole Foods Market | Food | Class I | 1 |
| 8 Oct 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health. | Avanos Medical, Inc. | Device | Class II | 2 |
| 8 Oct 2019 | Schwan's Garlic Herb Shrimp NET WT 16 oz. (1 lb.) Keep Frozen Cook Thoroughly Distributed By: Schwan's Home Service, Inc. Marshall. MN 56258 UPC 052008 (84024) | Fisherman's Pride Processor, Inc. dba Neptune Foods | Food | Class I | 1 |
| 8 Oct 2019 | Blue Bell Butter Crunch Ice Cream packaged in a 1/2 Gallon (2 Qts) paperboard cup & lid (4 units per corrugated sleeve, 77 sleeves per pallet). | Blue Bell Creameries, L.P. | Food | Class II | 1 |
| 7 Oct 2019 | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures;… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 7 Oct 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100),… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Oct 2019 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan… | Neocis Inc. | Device | Class II | 1 |
| 4 Oct 2019 | WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips | Teleflex Medical | Device | Class II | 2 |
| 4 Oct 2019 | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | Device | Class II | 5 |
| 4 Oct 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Randox Laboratories, Limited | Device | Class II | 3 |
| 4 Oct 2019 | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | Cordis Corporation | Device | Class II | 1 |
| 3 Oct 2019 | Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. | Cook Inc. | Device | Class II | 2 |
| 3 Oct 2019 | Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03 | Datascope Corp. | Device | Class II | 1 |
| 3 Oct 2019 | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 3 |
| 3 Oct 2019 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | Ethicon Endo-Surgery Inc | Device | Class I | 4 |
| 3 Oct 2019 | LUNCH BOX SANDWICHES CHICKEN SALAD; NET WT 4.5 oz (127G); MADE BY: GS Sandwich Co. Longs, SC 29568 843-399-2999; UPC 0 67068 12105 4 | Grand Strand Sandwich Company,Inc. | Food | Class I | 2 |
| 3 Oct 2019 | Honey Donut (Yahk Gwa), brand name Han Yang, packaged in a white Styrofoam boat wrapped in plastic wrap, 8 pieces per package, net wt. 18 oz. UPC 0 72148 48044 0. Product's label is read in parts: "***YAHK GWA*** Ingredients: Sweet Rice, Flour, Corn Syrup, Vegetable Oil, Water, Sugar, Salt ***Han Yang Oriental Food… (83983) | Han Yang Corp. | Food | Class II | 1 |
| 2 Oct 2019 | 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement.… | Exactech, Inc. | Device | Class II | 1 |
| 2 Oct 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 1 |
| 2 Oct 2019 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery | Pega Medical Inc. | Device | Class II | 1 |
| 2 Oct 2019 | Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 OZ (227 g), UPC: 854621004349 | The Great Spirits Baking Company, LLC | Food | Class III | 3 |
| 1 Oct 2019 | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) (83926) | Monarch Medical Technologies | Device | Class II | 1 |
| 1 Oct 2019 | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 4 |
| 1 Oct 2019 | Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) | Individual firm, name withheld | Drug | Class II | 18 |
| 1 Oct 2019 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603 | Sato Pharmaceutical Inc. | Drug | Class III | 4 |
| 1 Oct 2019 | Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01. | Sato Pharmaceutical Inc. | Drug | Class III | 1 |
| 1 Oct 2019 | Golden Dragon Almond Cookies in 5 lbs. box, each 5 lbs. box contains 5, 100 count bags, UPC on box and inner bag: 0 80005 23031 2 (83971) | Golden Dragon Fortune Cookies Co Inc | Food | Class I | 1 |
| 1 Oct 2019 | Dried Date NET WT: 12 oz(340g+/-5g) packed in clear plastic bag. Product of China. INGREDIENTS: DRTED DATE; Packed By: Fang Run Food Packaging Co., LTD 3 Zhengang Road, Shuibu Gangning Areat Aishan City, Guangdong, China; Distributed by: Super World Trading Inc. 28 Varick Avenue Brooklyn, New York 11237; UPC:… (83924) | Super World Trading Inc. | Food | Class I | 1 |
| 1 Oct 2019 | Glam Day Nougat Candy packaged in 6-ounce (170g) plastic packages containing individually wrapped units identified only as NOUGAT. 30 plastic packages per master case. The 6-ounce plastic bags listed the following codes: BEST BEFORE 10/15/2020; UPC 6 950296 804834. Ingredients: Peanuts, Sugar, liquid Glucose, Malt… | Rong Shing Trading NY Inc | Food | Class I | 1 |
| 30 Sep 2019 | Cranberry Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01414 3. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior selling to consumers. Refrigerated product is sold… | Jumbo Foods, Inc. | Food | Class I | 5 |
| 27 Sep 2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01 | Arbor Pharmaceuticals Inc. | Drug | Class III | 1 |
| 27 Sep 2019 | Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 5 |
| 27 Sep 2019 | CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unflavored Powdered Mix Multi-Mineral & Vitamin Supplement NET WT. Approximately 20.4 OZ (1.28 LB) 579g in white plastic bottles (83888) | Images Unlimited Products, dba Cellect Products | Food | Class II | 1 |
| 27 Sep 2019 | Honey Cake, internal PLU code 203190, is a seasonal bakery product. A loaf shaped cake is wrapped with cellophane, stored ambient, and sold from displayed tables. The orange sticker on top of the package is read in parts: "***SEASONAL HONEY CAKE ***Made in small batches, with Bee Local Willamette Valley Honey,… | New Seasons Market LLC | Food | Class II | 1 |
| 26 Sep 2019 | GANCHI NAIWEITANGPIAN Candy NET WT: 280G(9.8oz) in cardboard package. 24 packages per master case. The following codes are listed on the individual packages: 20190316 (stamped on box), BEST BEFORE: 03.15.2020, UPC 6926106100083. INGREDIENTS: sugar, glucose, planting the fat end, (glucose syrup, soybean oil,… (83898) | Rong Shing Trading Inc. | Food | Class II | 1 |
| 25 Sep 2019 | Tuna Poke CO AAA 2cm 10 lb case Tuna Poke COAAA 1.5cm 10 lb case | MICAL SEAFOOD | Food | Class II | 5 |
| 24 Sep 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Sep 2019 | Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06 | Apotex Inc. | Drug | Class II | 6 |
| 23 Sep 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Randox Laboratories, Limited | Device | Class III | 1 |
| 23 Sep 2019 | Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79 | AuroMedics Pharma LLC | Drug | Class III | 1 |
| 23 Sep 2019 | BETA FACTOR DIETARY SUPPLEMENT 60 capsules per plastic bottle, SKU: 100-4F | Basic Reset Inc. | Food | Class II | 14 |
| 23 Sep 2019 | Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Chocolate Chip Net Wt. 22 oz. (623.7g) UPC Code 680569160232 | California New foods | Food | Class I | 9 |
| 19 Sep 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel. | Philips Medical Systems (Cleveland) Inc | Device | Class I | 5 |
| 19 Sep 2019 | TherMax Blood Warmer Unit | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 Sep 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 5 |
| 18 Sep 2019 | Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples. | Biomedical Polymers, Inc. | Device | Class III | 2 |
| 18 Sep 2019 | Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor (83896) | Senseonics, Inc. | Device | Class II | 1 |
| 17 Sep 2019 | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax. | Cook Inc. | Device | Class II | 1 |
| 16 Sep 2019 | 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring. | Becton Dickinson & Company | Device | Class II | 1 |
| 16 Sep 2019 | CardioLab/ComboLab Recording Systems | GE Healthcare, LLC | Device | Class II | 1 |
| 16 Sep 2019 | SAROS Oxygen System Model 3000 | Caire, Inc. | Device | Class II | 1 |
| 16 Sep 2019 | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery | Synthes (USA) Products LLC | Device | Class II | 1 |
| 16 Sep 2019 | Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028 (83812) | FITOTERAPIA USA, INC | Drug | Class I | 1 |
| 16 Sep 2019 | Lemon Dessert Bars packaged under Schwartz Brothers Bakery brand in a 11.6 oz (328g), kraft packaging with UPC 7 17887 65163 7. The label is read in parts: "***LEMON DESSERT BARS*** Contains Milk, Soy, Wheat ***May Contain Eggs and Tree Nuts*** NET WT 11.6 OZ ***Produced By Schwartz Brothers Bakery Seattle, WA… | Schwartz Brothers Restaurants dba Schwartz Brothers Bakery | Food | Class I | 1 |
| 13 Sep 2019 | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372. | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 13 Sep 2019 | Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate | Productos La Samaritana, Inc. | Food | Class III | 2 |
| 10 Sep 2019 | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form. | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 10 Sep 2019 | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used… | MEDTECH SAS | Device | Class I | 1 |
| 10 Sep 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum. | Alto Development Corp | Device | Class II | 5 |
| 6 Sep 2019 | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management | ConvaTec, Inc | Device | Class II | 1 |
| 5 Sep 2019 | Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.) | Carroll-Baccari, Inc. | Device | Class II | 2 |
| 5 Sep 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle | Synthes (USA) Products LLC | Device | Class II | 1 |
| 4 Sep 2019 | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI | Abiomed, Inc. | Device | Class II | 1 |
| 30 Aug 2019 | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/… (83714) | Pajunk GmbH | Device | Class II | 1 |
| 29 Aug 2019 | Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2 (83761) | LABSTYLE INNOVATIONS | Device | Class II | 1 |
| 22 Aug 2019 | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System. | Thoratec Switzerland GMBH | Device | Class I | 1 |
| 21 Aug 2019 | Casablanca brand Non-Pareils Sprinkles in 12oz clear plastic container ING: sugar, dextrin, hum Arabic, glycerin, titanium dioxide, magnesirm silicate, carnauba wax, FD&C colors yellow #5, yellow #6, red #40, blue #1, red #3 tapioca starch & glucose powder Packed by : Spice N' More COrp. 349 Meserole St. Blyn., NY… (84013) | Spice N' More Corp. | Food | Class III | 1 |
| 19 Aug 2019 | Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system. | OrthoPediatrics Corp | Device | Class II | 2 |
| 15 Aug 2019 | Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use… | Western / Scott Fetzer Company | Device | Class II | 5 |
| 12 Aug 2019 | S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | Drug | Class II | 100 |
| 9 Aug 2019 | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 9 Aug 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to… | Randox Laboratories Ltd. | Device | Class II | 2 |
| 26 Jul 2019 | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to… | GE Healthcare, LLC | Device | Class II | 1 |
| 18 Jul 2019 | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904 | Individual firm, name withheld | Device | Class II | 2 |
| 17 Jul 2019 | Autoject EI, REF AJ1310 | Owen Mumford USA, Inc. | Device | Class II | 2 |
| 15 Jul 2019 | Port full Access Tray Product Code: DT19330 | Centurion Medical Products Corporation | Device | Class II | 4 |
| 3 Jul 2019 | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03 | Valeritas, Incorporated | Device | Class II | 5 |
| 2 Jul 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Device | Class II | 3 |
| 2 Jul 2019 | Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35 | Altaire Pharmaceuticals, Inc. | Drug | Class II | 134 |
| 1 Jul 2019 | Universal Sexual Health Testing Kit (83709) | Privapath Diagnostics Ltd | Device | Class II | 1 |
| 24 Jun 2019 | EPISTAXIS TRAY Kit Code: MNS10165 | Centurion Medical Products Corporation | Device | Class II | 3 |
| 14 Jun 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. (83119) | TELEFLEX-MORRISVILLE | Device | Class I | 1 |
| 11 Jun 2019 | StemPro¿ MSC SFM CTS" | Life Technologies Corporation | Device | Class II | 2 |
| 23 May 2019 | Various products which were contract sterilized. (83001) | Anewmed Corporation | Device | Class II | 1 |
| 10 May 2019 | Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use (83867) | Cadence Science, Inc. | Device | Class II | 1 |
| 19 Apr 2019 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | AURIS HEALTH INC | Device | Class II | 1 |
| 12 Apr 2019 | Posey Connected Twice-As-Tough Cuffs (82534) | TIDI PRODUCTS | Device | Class II | 1 |
| 10 Apr 2019 | MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9277 MZ9278 MZ9279 MZ9280 MZ9281 MZ9283 MZ9287 MZ9288 MZ9289 MZ9290 MZ9292… | Becton Dickinson & Company | Device | Class II | 1 |
| 7 Mar 2019 | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | Becton Dickinson & Company | Device | Class II | 1 |
| 8 Feb 2019 | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 18 Dec 2018 | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 | Insulet Corporation | Device | Class II | 1 |
| 12 Dec 2018 | Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical… | Applied Medical Resources Corp | Device | Class II | 2 |
| 26 Nov 2018 | ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 16 Nov 2018 | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve… | LivaNova USA Inc | Device | Class II | 1 |
| 9 Nov 2018 | AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255 | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Nov 2018 | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm: (83776) | Hager & Meisinger Gmbh | Device | Class II | 1 |
| 1 Nov 2018 | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one… | LivaNova USA Inc. | Device | Class II | 1 |
| 26 Oct 2018 | Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 16 Oct 2018 | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the… | Argon Medical Devices, Inc | Device | Class II | 9 |
| 1 Oct 2018 | C3 Wave App, v. 2.0.5 | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 28 Sep 2018 | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. | TriMed Inc. | Device | Class II | 5 |
| 27 Sep 2018 | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959 | Orthofix Srl | Device | Class II | 31 |
| 6 Sep 2018 | Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958 | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 15 Aug 2018 | TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization. | TriMed Inc. | Device | Class II | 1 |
| 14 Aug 2018 | TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the… (83707) | Tec Com Gmbh | Device | Class II | 1 |
| 7 Aug 2018 | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508). | Medtronic Inc. | Device | Class I | 2 |
| 25 Jul 2018 | HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114. (83853) | Hycor Biomedical LLC | Device | Class II | 1 |
| 11 Jul 2018 | POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree… (83540) | POM Medical LLC | Device | Class II | 1 |
| 8 Jun 2018 | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures. | Individual firm, name withheld | Device | Class II | 8 |
| 4 Jun 2018 | EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 27 Feb 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems | Helena Laboratories, Corp. | Device | Class III | 1 |
| 2 Sep 2016 | 2000 Vascular with 30 Degree option (83219) | Heritage Medical Products, Inc. | Device | Class II | 1 |