| 13 Aug 2020 | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola… Event 86138 | Pharmaceutical Innovations, Inc. | Device | Class II | 1 |
| 11 Aug 2020 | Price Chopper, Southwest Tex-Mex Trail Mix, 12 oz. re-closeable bag, 6 packages per case | United Natural Trading Inc. dba Woodstock Farms | Food | Class II | 1 |
| 10 Aug 2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75 | Sanofi-Aventis U.S. LLC | Drug | Class II | 1 |
| 10 Aug 2020 | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37 | Lannett Company, Inc. | Drug | Class II | 1 |
| 7 Aug 2020 | Gluten-Free Organic Mesa Sunrise Cereal USA, Nature's Path brand. Shop Order # 127895. Product is Ready to eat breakfast cereal and shelf stable. Packaged in poly film bag. Each bag has a net Wt. 26.4 oz., each case has 6 bags. Case UPC: 0 58449 77901 8. The label is read in parts: "***Gluten-Free***MESA SUNRISE REAL… Event 86206 | Natures Path Foods USA, Inc. | Food | Class II | 1 |
| 7 Aug 2020 | HIGH LINER FOODSERVICE***Genuine Maryland-Style Premium Crab Cakes***48-3 oz***KEEP FROZEN***10004302***PRODUCT OF CHINA***DISTRIBUTED BY: HIGH LINER FOODS< PORTSMOUTH, NY 03801; packaged in 9 lb bulk food service cases | High Liner Foods Inc. | Food | Class II | 1 |
| 6 Aug 2020 | HAVEN'S KITCHEN***GOLDEN TURMERIC TAHINI***NET WT 5oz (142g)***Ingredients: Water, Tahini, Extra Virgin Olive Oil, Roasted Garlic, Lemon Juice Concentrate, Date Paste, Sea Salt, Turmeric, Cumin, Ground Sumac (Sumac, Salt), White Pepper*** Event 86181 | Haven'S Kitchen | Food | Class I | 1 |
| 6 Aug 2020 | My Nana's Thick & Crunchy Tortilla Chips, 12 oz. (340g) paper bag (12 bags per case), UPC 0-34392-10161-8. Event 86215 | La Canasta Mexican Food Products, Inc. | Food | Class III | 1 |
| 6 Aug 2020 | "Wegmans***Food you Feel Good About*** Fruit on the Bottom***LOWFAT YOGURT*** PINEAPPLE ***6oz(170g)" Event 86192 | Upstate Niagara Cooperative, Inc. | Food | Class II | 1 |
| 6 Aug 2020 | Lund's and Byerly's Sea Salt Caramels, Net wt 16 oz (454 g), UPC 72431-00489 Event 86239 | Name withheld | Food | Class II | 1 |
| 6 Aug 2020 | Marketside Peanut Butter Brownie, Net Wt. 19 oz, Distributed by Walmart Inc. Bentonville, AR Event 86213 | James Skinner Baking Co. | Food | Class II | 1 |
| 5 Aug 2020 | MURRAY'S CHADS SMOKED GOUDA DIP in plastic tubs, all sizes. | The Kroger Co | Food | Class I | 17 |
| 4 Aug 2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16 | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Drug | Class II | 1 |
| 4 Aug 2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8 | Eosera, Inc. | Drug | Class II | 4 |
| 3 Aug 2020 | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 3 Aug 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007 | Ultra Seal Corporation | Drug | Class III | 2 |
| 3 Aug 2020 | Salmon, Burger Atlantic Blue Cheese Net Weight 12 oz (340g) UPC 23725500000; HEB Meal Simple Blue Cheese Salmon Burger NET WT 12 oz. (340g) UPC 23757500000; HEB Meal Simple Blue Cheese Wild Salmon Burgers NET WT 12oz (340g) UPC 23759000000; Salmon, Burger Atlantic Blue Cheese Net Weight 6 oz (170g) UPC 22528700000;… Event 86169 | Name withheld | Food | Class II | 1 |
| 30 Jul 2020 | Sweeteeth O-Snap! (White Chocolate & Ginger Snaps) Chocolate Bar, NET WT. 3 OZ. (85.05G), Manufactured by: Sweeteeth Chocolate LLC. 1204 McNew St. Hanahan, SC 29410 www.evopizza.com, Best By: 07/28/2021, UPC 7 36211 11895 0 Event 86143 | Sweeteeth Chocolate LLC | Food | Class II | 1 |
| 29 Jul 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | SCA Pharmaceuticals | Drug | Class II | 1 |
| 29 Jul 2020 | Earth Grown brand Mocha Fudge Non-Dairy Frozen Dessert in pint sized paperboard carton with a paperboard lid. | Smith Foods Inc. | Food | Class I | 3 |
| 28 Jul 2020 | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of… | Wright Medical Technology, Inc. | Device | Class II | 2 |
| 28 Jul 2020 | Island Spring Organics Extra Firm Organic Tofu, brand iXF-W12. Product is packaged in small square shapes into vacuum sealed pouches, net wt. 12 oz. Product is refrigerated. UPC is 0 74899 00006 9. The product label is read in parts: "***ISLAND SPRING ORGANICS Extra Firm Tofu***Net Wt. 12 oz. (340… Event 86132 | Island Spring Inc | Food | Class II | 1 |
| 27 Jul 2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17 | Calvin Scott & Company, Inc. | Drug | Class II | 19 |
| 24 Jul 2020 | Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history,… Event 86121 | Intrinsic Therapeutics, Inc. | Device | Class II | 1 |
| 24 Jul 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012. | Golden State Medical Supply Inc. | Drug | Class III | 1 |
| 24 Jul 2020 | VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35. | Vilvet Pharmaceuticals Inc. | Drug | Class II | 2 |
| 24 Jul 2020 | Kouign-Amann Pastry available in plastic clamshell 4-packs with Whole Foods Market scale labels, a PLU code 26739400000 | Whole Foods Market | Food | Class I | 1 |
| 24 Jul 2020 | Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India Event 86111 | Advanced Compounds International, Inc. | Food | Class I | 1 |
| 24 Jul 2020 | Garden Cut Organic Coleslaw w/ Carrots, retail unit packaged in 1lb clam-shell, 4 retail units per wholesale case, retail unit UPC: 053495081016 | Indianapolis Fruit Company, Inc. | Food | Class II | 1 |
| 24 Jul 2020 | Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser. | Wellements LLC | Food | Class I | 2 |
| 23 Jul 2020 | Stick-E Fingers Barbecue All Purpose Rub is a dry rub, packaged in 13.2 oz plastic jar, UPC 8 60003 24004 5. No company's address listed on the label. The product label is read in parts: "***STICK-E FINGERS BARBECUE***All Purpose Rub *** INGREDIENTS: SALT, ONION, BUTTER FLAVOR, GARLIC, PEPPER***". Event 86119 | Stick E Fingers BBQ LLC | Food | Class II | 1 |
| 23 Jul 2020 | UpSpring Baby Iron + Immunity MULTI + IRON + ZINC Promotes nutrition For Healthy Growth + Immune System Support For Infants 4 months + Natural Grape Flavor Easy To Use Dropper Dietary Supplement NET WT 2 FL OZ (60 ML)UPC No: 859188006805 packaged in dark brown glass bottles and placed in paper carton with dropper… Event 86103 | Upspring,ltd | Food | Class I | 1 |
| 23 Jul 2020 | Cheddar Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: CHEDDAR CHEESE BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C, Niacin, Reduced Iron, Thiamine… | San Francisco Street Bakery Inc. | Food | Class II | 17 |
| 23 Jul 2020 | Chantilly Key Lime Tartlets Net Wt 1 oz. individually packaged in plastic clamshell containers with Whole Foods Market scale labels, a PLU code of 268564 | Whole Foods Market | Food | Class I | 1 |
| 22 Jul 2020 | POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and… Event 86099 | Smith & Nephew Orthopaedics AG | Device | Class II | 1 |
| 22 Jul 2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10 | West-Ward Columbus Inc | Drug | Class III | 1 |
| 21 Jul 2020 | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment. | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Device | Class II | 1 |
| 21 Jul 2020 | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381 | Synthes (USA) Products LLC | Device | Class II | 1 |
| 21 Jul 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0 | Ferring Pharmaceuticals Inc | Drug | Class I | 3 |
| 21 Jul 2020 | Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin… | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 20 Jul 2020 | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function. Event 86085 | NOBEL BIOCARE SERVICES AG | Device | Class II | 1 |
| 20 Jul 2020 | BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal… | Becton Dickinson & Co. | Device | Class II | 1 |
| 20 Jul 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 | Pfizer Inc. | Drug | Class II | 1 |
| 20 Jul 2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 20 Jul 2020 | Strongbrew Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 898577002141 | Uncommon Canning LLC | Food | Class II | 2 |
| 18 Jul 2020 | Salmon cut and packaged in Styrofoam case approximately 19 kg per case | Topway Enterprises, Inc | Food | Class II | 2 |
| 17 Jul 2020 | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 17 Jul 2020 | VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. | Ortho Clinical Diagnostics | Device | Class II | 2 |
| 17 Jul 2020 | Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon… | Cytocell Ltd. | Device | Class II | 1 |
| 17 Jul 2020 | Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 17 Jul 2020 | Giant Eagle Dried Island Fruit Mix , Net Wt. 10 oz. , 6 units per case. Packaging is a gusseted plastic resealable bag. Expiration date 01/15/2021 Event 86089 | Name withheld | Food | Class II | 1 |
| 16 Jul 2020 | Tibial knee prosthesis | Smith & Nephew, Inc. | Device | Class II | 1 |
| 16 Jul 2020 | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and… | Philips North America, LLC | Device | Class II | 1 |
| 16 Jul 2020 | uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to,… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 2 |
| 16 Jul 2020 | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011 | Brainlab AG | Device | Class II | 2 |
| 16 Jul 2020 | Kasugai brand Matcha Ame (Green tea candy); 4.58 oz. plastic bag; 2 x 12 individual items per case Product of Japan Ingredients: glucose syrup, sugar, green tea powder, palm oil, artificial flavor. The label should include "mold lubricant oil (palm, rapseed, soybeans) Distributed by JFC International Inc. Los… | J F C International Inc | Food | Class II | 1 |
| 16 Jul 2020 | 1. FRESH CLAW AND KNUCKLE MEAT, 1 and 2 lbs. 2. FRESH CLAW, KNUCKLE, AND TAIL MEAT, 1 and 2 lbs 3. FROZEN CLAW AND KNUCKLE MEAT, 2 lb Event 86051 | Greenhead Lobster Products | Food | Class I | 1 |
| 16 Jul 2020 | Dietary supplements, 60 capsules, UPC 15033-61832, Product # 832060, labeled under the following brands and product names, packaged in white plastic bottle with black plastic lid: 1. Aspire Rejuvenation Nutraceuticals, Tranquility PM, Mfg for: Aspire Rejuvenation Nutraceuticals, 74550 Dr Phillips Blvd Ste 205,… Event 86086 | Provident Nutraceutical div. of Ortho Molecular Products Inc | Food | Class II | 1 |
| 15 Jul 2020 | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. | NeuroLogica Corporation | Device | Class II | 1 |
| 15 Jul 2020 | Whole Foods Spinach Artichoke Dip ,4-12 oz containers, Lot # 248 Manufactured on 7/8/2020 Use By: 07/26/2020 | Winter Gardens Quality Foods, Inc. | Food | Class I | 1 |
| 15 Jul 2020 | Happy Colon Yum Shortbread Cookie 0.98oz UPC 56817 00704 | Happy Colon Foods | Food | Class II | 2 |
| 14 Jul 2020 | Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 | Olympus Corporation of the Americas | Device | Class II | 2 |
| 14 Jul 2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 13 Jul 2020 | Khaotan Rice Cracker, Net Wt. 150g Event 86064 | Siam Trading Inc. | Food | Class II | 1 |
| 9 Jul 2020 | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 | Mako Surgical Corporation | Device | Class II | 1 |
| 9 Jul 2020 | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris. | Medline Industries Inc | Device | Class II | 1 |
| 8 Jul 2020 | Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. | Flower Orthopedics Corporation | Device | Class II | 6 |
| 7 Jul 2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50 | Mylan Institutional LLC | Drug | Class I | 1 |
| 6 Jul 2020 | Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. Event 86106 | Golden Technologies, Inc. | Device | Class II | 1 |
| 6 Jul 2020 | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053 | OrthoPediatrics Corp | Device | Class II | 1 |
| 6 Jul 2020 | Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space. | Arrow International Inc | Device | Class II | 4 |
| 6 Jul 2020 | Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation. | TELEFLEX MEDICAL INC | Device | Class II | 7 |
| 6 Jul 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and… | Boston Scientific Corporation | Device | Class II | 7 |
| 6 Jul 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 6 Jul 2020 | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02 | Allergan PLC | Drug | Class III | 2 |
| 2 Jul 2020 | PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1 Event 86034 | Whirlpool Corporation | Device | Class II | 1 |
| 2 Jul 2020 | Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | MasterPharm LLC | Drug | Class II | 26 |
| 2 Jul 2020 | Hostess Raspberry Zingers, Raspberry Iced Cake With Creamy Fillling, packaged in the following ways: 1) in boxes containing 10 cakes Net Wt. 13.4 OZ (380 g) UPC 88109110604 and 2) in clear plastic bags containing 3 cakes Net Wt. 4.02 OZ (114 g) UPC 888109010089 | Hostess Brands, LLC | Food | Class II | 1 |
| 1 Jul 2020 | Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH… Event 85978 | Spartan Chemical Co Inc | Drug | Class I | 1 |
| 30 Jun 2020 | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure… | TELEFLEX MEDICAL INC | Device | Class II | 2 |
| 30 Jun 2020 | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration… | Hill-Rom, Inc. | Device | Class II | 2 |
| 30 Jun 2020 | ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only. | Medline Industries Inc | Device | Class II | 2 |
| 30 Jun 2020 | Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. | CareFusion 303, Inc. | Device | Class II | 5 |
| 30 Jun 2020 | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Jun 2020 | Alaris System PC Unit Model 8000 modular infusion pump and monitoring system | CareFusion 303, Inc. | Device | Class I | 2 |
| 30 Jun 2020 | Alaris Pump Module Model 8100 | CareFusion 303, Inc. | Device | Class I | 1 |
| 30 Jun 2020 | Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system | CareFusion 303, Inc. | Device | Class I | 8 |
| 29 Jun 2020 | PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis,… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 29 Jun 2020 | The Vitamin Shoppe Calcium Citrate Plus Magnesium & Vitamin D. 100 count (VS-1086; UPC:6653601086), 300 count (VS-1087; UPC: 6653601087), and 600 count (VS-1123; UPC: 6653601123). Event 86041 | Name withheld | Food | Class III | 1 |
| 26 Jun 2020 | InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation… | Steris Corporation | Device | Class II | 1 |
| 26 Jun 2020 | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. | RANDOX LABORATORIES, LTD. | Device | Class II | 3 |
| 26 Jun 2020 | PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual… Event 86082 | Precision Valve & Automation,Inc | Device | Class II | 1 |
| 26 Jun 2020 | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the… Event 86040 | Boss Instruments, Ltd. | Device | Class II | 1 |
| 26 Jun 2020 | Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 | Smiths Medical ASD Inc. | Device | Class I | 2 |
| 26 Jun 2020 | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the… | Covidien Llc | Device | Class II | 2 |
| 25 Jun 2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5. Event 85944 | POLARIZED LLC | Drug | Class II | 1 |
| 24 Jun 2020 | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions. | Arthrex, Inc. | Device | Class II | 1 |
| 24 Jun 2020 | Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 24 Jun 2020 | SUTUREFIX ULTRA Suture, Product number 72203855 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 24 Jun 2020 | Banana Nut Bread Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams. | BUILT BRANDS LLC | Food | Class II | 9 |
| 23 Jun 2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an… Event 86035 | Sutter Medizintechnik GmbH | Device | Class II | 1 |
| 23 Jun 2020 | TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses | Chengdu Ai Qin E-commerce Co., Ltd | Device | Class II | 7 |
| 23 Jun 2020 | All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0 Event 85987 | Itech 361 LLC | Drug | Class I | 1 |
| 23 Jun 2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32 | CareFusion 213, LLC | Drug | Class I | 3 |
| 22 Jun 2020 | CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. | GE Healthcare, LLC | Device | Class II | 1 |
| 22 Jun 2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5. Event 85942 | UVT INC | Drug | Class I | 1 |
| 20 Jun 2020 | Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 3 |
| 19 Jun 2020 | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be… | Argon Medical Devices, Inc | Device | Class II | 1 |
| 19 Jun 2020 | Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 18 Jun 2020 | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 18 Jun 2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin. | Synthes, Inc. | Device | Class II | 1 |
| 18 Jun 2020 | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0 | Chembio Diagnostics, Inc | Device | Class II | 3 |
| 18 Jun 2020 | Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions. Event 85958 | Anjon Holdings | Device | Class II | 1 |
| 18 Jun 2020 | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. | Philips North America, LLC | Device | Class II | 3 |
| 18 Jun 2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29084 2 | Name withheld | Drug | Class I | 36 |
| 17 Jun 2020 | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. | Resource Optimization & Innovation LLC | Device | Class II | 1 |
| 16 Jun 2020 | MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin. Event 85951 | Synthes Produktions GmbH | Device | Class II | 1 |
| 15 Jun 2020 | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. | Luminex Corporation | Device | Class II | 2 |
| 13 Jun 2020 | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA | Yusef Manufacturing Laboratories, LLC | Drug | Class II | 1 |
| 5 Jun 2020 | StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 5 Jun 2020 | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the… | Richard Wolf GmbH | Device | Class II | 1 |
| 5 Jun 2020 | STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives. | HF Acquisition Co. LLC | Device | Class II | 1 |
| 4 Jun 2020 | HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300 | HF Acquisition Co., LLC | Device | Class II | 4 |
| 1 Jun 2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094 Event 85926 | WORLD EVENT PROMOTIONS, LLC | Drug | Class II | 1 |
| 30 Apr 2020 | Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system. | Normand-Info S.A.S.U. | Device | Class II | 1 |
| 21 Apr 2020 | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 15 Apr 2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE. Event 85574 | Summitt Labs | Drug | Class I | 1 |
| 26 Mar 2020 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 6 Mar 2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed. Event 85094 | Name withheld | Device | Class III | 1 |
| 8 Jan 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 15 Aug 2019 | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask. | Bioseal Corporation | Device | Class II | 1 |