| 20 Apr 2020 | Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 15 Apr 2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 15 Apr 2020 | Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count… | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 14 Apr 2020 | Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100 Event 85440 | B & B Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 11 Apr 2020 | Roasted/Salted Deluxe Mixed Nuts; Net Wt. 10 oz./284 g, Clear plastic container UPC 65143370994 Cashews, Almonds, Brazil Nuts, Hazelnuts, Pecan Halves, Macadamia Nuts, Canola Oil, salt. Contains Tree nuts (Cashews, Almonds, Brazil Nuts, Hazelnuts, Macadamia Nuts, Pecans). May contain Shell or Fragments. Product of… | DSD Merchandisers, Inc. | Food | Class II | 1 |
| 10 Apr 2020 | Lake Champlain CHOCOLATES, COIN DARK BULK ORG, NET WT 48 OZ (1.3 kg), APPROX 186 PIECES, INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, COCOA POWDER (PRESSED WITH ALKALI), AND VANILLA POWDER) MAY CONTAIN TRACES OF MILK, PEANUTS, SOYBEAN, TREE NUTS, AND WHEAT | Champlain Chocolate Company | Food | Class I | 1 |
| 7 Apr 2020 | Enoki Mushroom; 7.5oz (200g); UPC #831211204181; packed in clear plastic bag with green label; imported from Green Co. located in Korea; distributed from February 15th, 2020 to March 5th, 2020. | H & C Food Inc. | Food | Class I | 1 |
| 6 Apr 2020 | Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | The Medicine Shoppe Pharmacy | Drug | Class II | 54 |
| 3 Apr 2020 | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 1 Apr 2020 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 31 Mar 2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3 | Noven Therapeutics, LLC | Drug | Class II | 3 |
| 30 Mar 2020 | Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01 | Par Pharmaceutical Inc. | Drug | Class II | 1 |
| 27 Mar 2020 | We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 Capsules Event 85358 | CT Health Solutions, LLC | Food | Class III | 1 |
| 26 Mar 2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09 | Avet Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 26 Mar 2020 | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy | Drug | Class II | 5 |
| 26 Mar 2020 | Fresh Salmon; Brand names : Bakka, Superior, Scottish Canada, Ocean Quality, Norway. Refrigerate Unit size: 10-12 lbs., 14-16 lbs., 16-18 lbs., 18-20 lbs,; packed in Styrofoam box; 2 pieces, 3 pieces or 4 pieces in the box. Event 85328 | MIN JIANG FOOD STORE INC DBA KOI KOI TRADING | Food | Class I | 1 |
| 25 Mar 2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00 | Teva Pharmaceuticals USA | Drug | Class II | 3 |
| 25 Mar 2020 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02 | Akorn Inc | Drug | Class III | 1 |
| 24 Mar 2020 | Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | Name withheld | Drug | Class II | 70 |
| 24 Mar 2020 | Audrey's Chia Cookies Chocolate Chip, 4 OZ flexible pouch packaging, UPC Code: 858652007003, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case. | Health Harvest, LLC | Food | Class II | 4 |
| 23 Mar 2020 | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel… | LeMaitre Vascular, Inc. | Device | Class I | 1 |
| 23 Mar 2020 | Olympus Pleuravideoscope, Model LTF-160 | Olympus Corporation of the Americas | Device | Class II | 2 |
| 23 Mar 2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 23 Mar 2020 | Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01 | Avet Pharmaceuticals, Inc. | Drug | Class I | 2 |
| 20 Mar 2020 | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and… | Physio-Control, Inc. | Device | Class II | 1 |
| 20 Mar 2020 | Whole Foods Vodka Sauce, 6-16 oz. containers. | Winter Gardens Quality Foods, Inc. | Food | Class I | 1 |
| 20 Mar 2020 | HUANGFUSHANZHEN; Dried Mushroom; Net Weight: 170G/6 OZ; Ingredient: Dried Mushroom; PRODUCT OF CHINA; SOLE AGENT: TIFFANY FOOD CORP; UPC: 6 943153 804047 | Tiffany Food Corp. | Food | Class I | 1 |
| 20 Mar 2020 | Amy's Kitchen gluten Free Vegetable Lasagna, UK Microwave or oven bake - keep frozen Item # 000374, UPC 0 042272 003747 net weight 255g Amy's Kitchen Bedford MK | Amys Kitchen Inc | Food | Class II | 1 |
| 19 Mar 2020 | Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Drug | Class II | 1 |
| 19 Mar 2020 | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30 | Jubilant Draximage Inc | Drug | Class II | 1 |
| 19 Mar 2020 | Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698 | Filltech USA, LLC | Drug | Class II | 2 |
| 19 Mar 2020 | PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per case) and 48 oz. bags (6 bags per case). UPC: 0001111079120 | The Kroger Co | Food | Class II | 2 |
| 18 Mar 2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01 | Aurobindo Pharma USA Inc. | Drug | Class II | 9 |
| 18 Mar 2020 | Aseltines 100% JUICE Apple Cider 1/2 gallon UPC 5169600064 and 1 gallon UPC 5169600128 Event 85244 | Aseltines | Food | Class II | 1 |
| 18 Mar 2020 | Lindt & Sprungli (USA), Inc.; Excellence 85% Cocoa Dark Chocolate; Net WT 3.5OZ (100g) Event 85263 | Lindt & Sprungli (USA), Inc. | Food | Class II | 1 |
| 17 Mar 2020 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 17 Mar 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder. | Degania Medical Devices Pvt. Ltd. | Device | Class II | 11 |
| 17 Mar 2020 | RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling. Event 85270 | Rayner Intraocular Lenses Limited | Device | Class II | 1 |
| 17 Mar 2020 | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Smith & Nephew, Inc. | Device | Class II | 2 |
| 16 Mar 2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. | Life Technologies Corporation | Device | Class II | 4 |
| 16 Mar 2020 | Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501 Event 85232 | Y-O Management LLC, dba Natural Remedy Store | Drug | Class I | 1 |
| 16 Mar 2020 | Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. Event 85231 | Name withheld | Drug | Class I | 1 |
| 16 Mar 2020 | Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952 Event 85234 | The Medicine Shoppe Pharmacy | Drug | Class II | 1 |
| 16 Mar 2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister | Glaxosmithkline Consumer Healthcare Holdings | Drug | Class II | 5 |
| 16 Mar 2020 | ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12 | PharMEDium Services, LLC | Drug | Class II | 13 |
| 16 Mar 2020 | Kudzu Root (Pueraria montana var. lobata), This product was packaged in a clear plastic bag or poly-woven bags sold in bulk form net weight ranges from 4 ounces to 20 pounds. The label is read in parts: "***Kudzu Root***Herbal Supplement **Origin: China** MOUNTAIN ROSE HERBS EUGENE, OR ****" Event 85246 | Mountain Rose Inc. dba Mountain Rose Herbs | Food | Class I | 1 |
| 13 Mar 2020 | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy… | Biomet, Inc. | Device | Class II | 1 |
| 13 Mar 2020 | C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05. | Medical Center Pharmacy, Inc. | Drug | Class II | 5 |
| 13 Mar 2020 | Case Label: Rice Dirty Mix Comp 24-17.9 oz bags/case, PACKED EXCLUSIVELY FOR: BR 9432 SOUTHERN PINE BLVD. CHARLOTTE, NC 28273. Bag Label: Bojangles Complete Dirty Rice Mix Net Wt: 17.9 oz bags Event 85220 | Mcclancy Seasoning Company | Food | Class II | 1 |
| 13 Mar 2020 | WinCo Foods frozen Blackberries, item # 107414, packaged in polyethylene bags, with a net weight of 16 oz (1 lb or 454g). UPC: 70552 30502. Product is distributed by WinCo Foods, LLC, Boise, ID 83704. The label is read in parts: "***WinCo Foods***Blackberries*** INGREDIENTS: BLACKBERRIES***KEEP FROZEN***PRODUCT OF… | Winco Foods Llc | Food | Class II | 2 |
| 13 Mar 2020 | Food You Feel Good About, Ginger Salmon, Oven Safe | Raw Seafoods Inc. | Food | Class II | 2 |
| 12 Mar 2020 | Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN | Fresenius Medical Care Holdings, Inc. | Device | Class II | 2 |
| 12 Mar 2020 | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 12 Mar 2020 | Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0.498 pounds; 20 individual trays per case Distributed by AFC Distribution Corp. Rancho Dominguez, CA Event 85225 | Advanced Fresh Concepts Corp | Food | Class II | 1 |
| 11 Mar 2020 | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed. | Biomerieux Inc | Device | Class II | 1 |
| 11 Mar 2020 | Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds Event 85214 | Boddingtons Plastics Ltd | Device | Class II | 1 |
| 11 Mar 2020 | Guan's Enoki Mushrooms; Net Weight 200 g - 7.05 oz. UPC: 8 59267007013 Product Number:50130 Product of Korea, Keep refrigerated Distributed by Guan's Mushroom Co. Los Angeles, CA Package is clear plastic top with Guan's logo, green bottom with Enoki Mushroom in English, Korean and French | Forest Mushroom Food Inc. | Food | Class I | 1 |
| 10 Mar 2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air… | Radiometer Medical ApS | Device | Class II | 1 |
| 10 Mar 2020 | Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Matthew 7:25 Inc dba Thrive Pharmacy | Drug | Class II | 3 |
| 9 Mar 2020 | ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 9 Mar 2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit | Name withheld | Device | Class II | 12 |
| 9 Mar 2020 | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines. | Sysmex America, Inc. | Device | Class II | 1 |
| 6 Mar 2020 | Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643 | Cook Inc. | Device | Class II | 2 |
| 6 Mar 2020 | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01. | Nostrum Laboratories Inc | Drug | Class II | 1 |
| 6 Mar 2020 | Meijer Mixed Nuts with Peanuts & Sea Salt 16 Oz UPC: 7-19283-80863-9 | Meijer Inc. | Food | Class II | 1 |
| 6 Mar 2020 | Enoki Mushroom; Product of Korea; Net Wt. 7.05 oz., (200 g) UPC: 7 426852 625810 The Enoki is packaged in a clear film, bottom portion will be a green back group. With Enoki Mushroom in Orange letters, under that will be Product of Korea, 7.05 oz / 200g Sun Hong Foods, Inc. 1105 W. Oylmpic Blvd. Montebello, CA 90604… Event 85172 | Hong Bin Foods LLC | Food | Class I | 1 |
| 6 Mar 2020 | Baskin Robbins Mint Chocolate Chip, Ice Cream Sandwiches with Mint Ice Cream, Semi-Sweet Chocolate Chips & Chocolate Wafers 4 Pack; 4 3.5 FL OZ (104 mL) Sandwiches /14 FL OZ (414 mL) | Dean Foods, Inc. | Food | Class II | 1 |
| 5 Mar 2020 | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1 | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 5 Mar 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Respironics California, LLC | Device | Class II | 1 |
| 5 Mar 2020 | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Device | Class II | 1 |
| 5 Mar 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system. | Baxter Healthcare Corporation | Device | Class II | 3 |
| 4 Mar 2020 | RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 4 Mar 2020 | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes:… | Diagnostica Stago, Inc. | Device | Class II | 1 |
| 3 Mar 2020 | Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. | Capintec Inc | Device | Class II | 1 |
| 3 Mar 2020 | PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma,… | Yusef Manufacturing Laboratories, LLC | Drug | Class II | 1 |
| 2 Mar 2020 | Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs. Event 85154 | Merits Holdings Co. dba Merits Health Products, Inc. | Device | Class II | 1 |
| 2 Mar 2020 | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997 | CSL Behring GmbH | Device | Class II | 1 |
| 2 Mar 2020 | Nature's Earthly Choice Organic Lentil Trio product containing a blend of red split, black and green lentils, labeled Gluten-Free, packaged in stand up resealable pouch, 12 oz. (340 g), UPC 6 79948 10006 8. The product's label is read in parts: "*** Gluten-Free *** ORGANIC LENTIL TRIO ***Red Split, Green and Black… Event 85107 | Global Juices & Fruits LLC | Food | Class II | 1 |
| 2 Mar 2020 | Whole Foods Market Green Chile Chicken Tamale served as a Family Meal, Chef's Case, Packaged, Frozen and on he hot bar PLU 72429 packaged in plastic containers and in family-style meal kits | Whole Foods Market | Food | Class I | 1 |
| 2 Mar 2020 | ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G SINGLE PACKET Other Ingredients: Non-GMO rBGH-Free Whey Protein Concentrate, Rice Bran and Germ*** Manufactured for & distributed by: New Capstone, Inc. 125 Trade Court, Suite F44, Mooresville, NC 28117 1-888-577-3703 UPC 8 67780 00020 6 Event 85126 | New Capstone, Inc | Food | Class I | 1 |
| 28 Feb 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads. | Abbott | Device | Class II | 1 |
| 28 Feb 2020 | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity. | CooperSurgical, Inc. | Device | Class III | 1 |
| 28 Feb 2020 | Nature's Blend Folic Acid 1000 mcg Dietary Supplement, 1000-count bottle, Product Number: 1280, UPC 0-79854-51280-9 Event 85151 | National Vitamin Company Inc | Food | Class III | 1 |
| 27 Feb 2020 | NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 27 Feb 2020 | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint. | DeRoyal Industries Inc | Device | Class II | 1 |
| 27 Feb 2020 | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides… | Gentell, Inc | Device | Class II | 4 |
| 27 Feb 2020 | DION DION DRIED MUSHROOMS, Product Origin from Haiti, Net Wt. 1/4 oz | DANA USA Corp. | Food | Class III | 2 |
| 26 Feb 2020 | ClearCanvas RIS/PACS | Synaptive Medical Inc | Device | Class II | 2 |
| 26 Feb 2020 | BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. | Biomet, Inc. | Device | Class II | 33 |
| 25 Feb 2020 | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589 | Biomet, Inc. | Device | Class II | 1 |
| 25 Feb 2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly | Acutus Medical Inc | Device | Class II | 4 |
| 25 Feb 2020 | Driscoll's Blackberries; 6 oz. clamshell container; 12 x 6 oz. clamshells per tray; 12 clamshells per case Driscoll's, Watsonville, CA | Driscoll's Inc. | Food | Class II | 1 |
| 25 Feb 2020 | Red Pozole Soup Starter, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). or 24 fl. oz. 16 fl oz UPC 738283379109 24 fl oz UPC 860322002201 The label is read in parts: "***RED POZOLE SOUP STARTER ***NET WT. 24 OZ. ***INGREDIENTS: Water, Hominy, Guajillo, Ancho, Lime Juice, Kosher Salt,… | Proxy Foods LLC | Food | Class II | 3 |
| 24 Feb 2020 | Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound… Event 85185 | Butterfly Network, Inc. | Device | Class II | 1 |
| 24 Feb 2020 | Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures. Event 85178 | Butterfly Network, Inc. | Device | Class II | 1 |
| 24 Feb 2020 | American Classic Snack Company Sweet Bourbon Crunchers Pretzels in 8 oz. bags, 12 bags per case. Event 85188 | American Classic Snack Co, LLC | Food | Class II | 1 |
| 24 Feb 2020 | Alkamind Creamy Chocolate Organic Daily Protein; 450g Plastic Bottle; Finished Product Item # FAMCDP450G; 3 core alkaline proteins Distributed by Alkamind LLC, New York, NY 10028 | Organic By Nature, Inc. | Food | Class III | 14 |
| 21 Feb 2020 | AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) | Qiagen Sciences LLC | Device | Class II | 1 |
| 21 Feb 2020 | Raisins packed in following brand names and sizes: 6 pack cartons (6 X 1 oz. boxes) - Pickwell Farms, Southern Grove, Winco, Schnucks, Essential Everyday, 20 oz. paper canisters; Schnucks, Winco, Essential Everday, Best Yet, Big Y 5 oz. cello bag - Slater Bros. Event 85093 | Caruthers Raisin Packing Co., Inc. | Food | Class II | 1 |
| 20 Feb 2020 | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 20 Feb 2020 | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI… | Philips North America, LLC | Device | Class II | 1 |
| 20 Feb 2020 | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults. | Radiometer Medical ApS | Device | Class II | 1 |
| 19 Feb 2020 | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies | Haemonetics Corporation | Device | Class II | 1 |
| 19 Feb 2020 | NATURAL GROCERS PEANUT CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087562088, Packaged by Vitamin Cottage Natural Food Markets, Inc., Lakewood, CO 80228 | Vitamin Cottage Natural Food Markets, Inc. | Food | Class II | 2 |
| 18 Feb 2020 | Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities. Event 85086 | James Leckey Design Ltd | Device | Class II | 1 |
| 18 Feb 2020 | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy. | Randox Laboratories Ltd. | Device | Class II | 1 |
| 18 Feb 2020 | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 17 Feb 2020 | iChemVELOCITY Strips, Catalog 800-7212 | Beckman Coulter, Inc. | Device | Class II | 1 |
| 17 Feb 2020 | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system. | Biomet, Inc. | Device | Class II | 1 |
| 14 Feb 2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class I | 2 |
| 14 Feb 2020 | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 14 Feb 2020 | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) | Hill-Rom Inc. | Device | Class II | 1 |
| 13 Feb 2020 | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod… | Insulet Corporation | Device | Class II | 1 |
| 13 Feb 2020 | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 6 |
| 13 Feb 2020 | Russian Bear 10000 Weight Gainer Formula Vanilla packed in 15lb bags | NutraBlend Foods, Inc. LLC | Food | Class III | 4 |
| 12 Feb 2020 | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) | Microbiologics Inc | Device | Class II | 2 |
| 11 Feb 2020 | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Event 85092 | MEDTRONIC ATS MEDICAL, INC. | Device | Class II | 1 |
| 11 Feb 2020 | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a… Event 85016 | Intellijoint Surgical, Inc. | Device | Class II | 1 |
| 11 Feb 2020 | Imager II 5F Angiographic Catheters, 5 units per package. | Boston Scientific Corporation | Device | Class I | 1 |
| 10 Feb 2020 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 1 |
| 10 Feb 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022. | Medline Industries Inc | Device | Class II | 3 |
| 10 Feb 2020 | SPICE (JWH-018) CC443 Event 85259 | Carolina Liquid Chemistries Corp | Device | Class II | 1 |
| 5 Feb 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK… | bioMerieux, Inc. | Device | Class II | 1 |
| 4 Feb 2020 | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. | LivaNova USA Inc | Device | Class II | 1 |
| 4 Feb 2020 | HEMO-7 Hemospray Endoscopic Hemostat | Wilson-Cook Medical Inc. | Device | Class II | 2 |
| 3 Feb 2020 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. | Dexcom Inc | Device | Class II | 3 |
| 3 Feb 2020 | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a… | Conformis, Inc. | Device | Class II | 2 |
| 3 Feb 2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | Radiometer Medical ApS | Device | Class II | 2 |
| 29 Jan 2020 | Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 28 Jan 2020 | UNCOOKED SWEET POTATO CRUSTED ALASKA POLLOCK NUGGETS 5 LBS 2.26KG DISTRIBUTED BY CORINTHIAN FOODS ST. SIMONS ISLAND, GA 31622 UPC 8 50008 56763 6 Event 84919 | Corinthian Trading Inc | Food | Class III | 1 |
| 28 Jan 2020 | Southern Sisters Gourmet Apple Crisp mix | Southern Sisters Gourmet | Food | Class II | 8 |
| 24 Jan 2020 | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week). | bioMerieux, Inc. | Device | Class II | 1 |
| 24 Jan 2020 | LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 21 Jan 2020 | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. | Sysmex America, Inc. | Device | Class II | 1 |
| 20 Jan 2020 | FlipCutter III Drill Event 85019 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Device | Class II | 1 |
| 20 Jan 2020 | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent Event 85229 | Carolina Liquid Chemistries Corp | Device | Class II | 1 |
| 17 Jan 2020 | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually… | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Jan 2020 | Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes | Smiths Medical ASD, Inc. | Device | Class II | 2 |
| 30 Dec 2019 | Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis. | Solta Medical Inc | Device | Class II | 1 |
| 30 Dec 2019 | Clover seed in 50 lb. woven poly bags, 40 bags to a pallet. | International Sprout Holding Inc. | Food | Class I | 2 |
| 23 Dec 2019 | LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) | Carroll-Baccari, Inc. | Device | Class II | 4 |
| 13 Dec 2019 | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test. | Beckman Coulter Inc. | Device | Class II | 1 |
| 6 Dec 2019 | Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to… Event 85089 | Name withheld | Device | Class II | 1 |
| 28 Nov 2019 | aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 | AAP Implantate Ag | Device | Class II | 1 |
| 15 Nov 2019 | Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1 | Grato Holdings, Inc. | Drug | Class III | 1 |
| 14 Nov 2019 | Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 | Abbott Diabetes Care, Inc. | Device | Class II | 3 |
| 6 Nov 2019 | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in… | Qualigen Inc | Device | Class II | 1 |
| 4 Nov 2019 | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 | Trilliant Surgical, LLC | Device | Class II | 1 |
| 11 Oct 2019 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 Event 85083 | Name withheld | Device | Class II | 1 |
| 9 Oct 2019 | Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934 Event 85121 | Signature Orthopaedics Europe Ltd | Device | Class II | 1 |
| 9 Oct 2019 | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply… | Medivators, Inc. | Device | Class II | 7 |
| 2 Oct 2019 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | Zeiss, Carl Inc | Device | Class II | 1 |
| 1 Oct 2019 | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Without Suture Plugs, (01)00801741026737; 3.… | Bard Peripheral Vascular Inc | Device | Class II | 10 |
| 24 Sep 2019 | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. Event 85240 | Name withheld | Device | Class II | 1 |
| 16 Sep 2019 | KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired Event 85315 | KT Health, LLC | Device | Class II | 1 |
| 4 Sep 2019 | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine. | Beckman Coulter Inc. | Device | Class II | 2 |
| 28 Aug 2019 | NavLock Tracker *** Rx Only | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 27 Aug 2019 | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope | Name withheld | Device | Class II | 3 |
| 26 Aug 2019 | Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging,… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 23 Aug 2019 | Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the… | Ra Medical Systems, Inc. | Device | Class II | 1 |
| 27 Jun 2019 | MiniMed Insulin Pump, model # MMT-508 | Name withheld | Device | Class II | 16 |
| 30 May 2019 | Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain. | Boston Scientific Neuromodulation Corporation | Device | Class II | 5 |
| 22 May 2019 | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. | Abbott Laboratories | Device | Class II | 1 |
| 17 May 2019 | Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. | Beckman Coulter Inc. | Device | Class II | 1 |
| 1 May 2019 | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the… | Abbott Laboratories, Inc | Device | Class II | 1 |
| 25 Apr 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 12 Apr 2019 | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF)… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 10 Apr 2019 | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref.… | Name withheld | Device | Class II | 2 |
| 9 Apr 2019 | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com Event 84698 | QUIDEL CARDIOVASCULAR INC | Device | Class II | 1 |
| 25 Mar 2019 | Canon Aquilion Lightning, Model TSX-036A | Canon Medical System, USA, INC. | Device | Class II | 8 |
| 27 Jul 2018 | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer | Synvasive Technology Inc | Device | Class II | 1 |
| 25 Jul 2018 | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. | Alcon Research LLC | Device | Class II | 1 |
| 19 Jul 2018 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical, Houston, TX. | Trilliant Surgical, LLC | Device | Class II | 10 |
| 10 Jul 2018 | djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX. | Encore Medical, LP | Device | Class II | 1 |
| 9 Jul 2018 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 18 Dec 2017 | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90. | Johnson & Johnson Vision Care, Inc. | Device | Class II | 1 |