| 19 Feb 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071 | Amerigen Pharmaceuticals Inc. | Drug | Class III | 1 |
| 13 Feb 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 13 Feb 2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 (82127) | Perrigo New York, Inc. | Drug | Class III | 1 |
| 13 Feb 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 8 Feb 2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71. | Avella of Deer Valley, Inc. Store 38 | Drug | Class II | 4 |
| 7 Feb 2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37 (80878) | ACP Nimble Buyer, Inc. | Drug | Class III | 1 |
| 6 Feb 2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA. (82065) | Individual firm, name withheld | Drug | Class III | 1 |
| 6 Feb 2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72 | Advanced Pharma Inc. | Drug | Class II | 1 |
| 6 Feb 2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99. | Advanced Pharma Inc. | Drug | Class III | 3 |
| 4 Feb 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09 | ICU Medical Inc | Drug | Class II | 1 |
| 4 Feb 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01. | Akorn Inc | Drug | Class II | 1 |
| 1 Feb 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 1 Feb 2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23. | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 31 Jan 2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01 (82085) | Individual firm, name withheld | Drug | Class II | 1 |
| 30 Jan 2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. | Valeant Pharmaceuticals North America LLC | Drug | Class III | 5 |
| 30 Jan 2019 | Bundle Organics Bar Salty Nuts and Seeds, 1.9 Oz snack bar, Ambient storage | 1908 Brands | Food | Class II | 6 |
| 30 Jan 2019 | DUNKIN' DONUTS MULTIGRAIN BAGEL DOUGH PRODUCT APPROVED BY: DUNKIN'DONUTS Unit wt: 4.5oz Count: 104 units Net Wt: 29 lb 4 oz (13.3 kg) 007 73889 10213 3 (82032) | Dunkin Brands Inc | Food | Class II | 1 |
| 29 Jan 2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407 | US Compounding Inc | Drug | Class II | 1 |
| 28 Jan 2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 25 Jan 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701. | Akorn Inc | Drug | Class III | 1 |
| 25 Jan 2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA (81999) | Individual firm, name withheld | Drug | Class I | 1 |
| 25 Jan 2019 | BOSTON SMOKED FISH CO. Nova Lox Sides, 5 packages of 2 pound units in corrugated box, Store at or below 38 deg, UPC: (01)90857016007065(3202)100000 (81986) | The Boston Smoked Fish Company LLC | Food | Class I | 1 |
| 24 Jan 2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 24 Jan 2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303. | US Compounding Inc | Drug | Class II | 1 |
| 23 Jan 2019 | Thrive Market Organic Almond Butter Creamy 16 oz. SKU/UPC 671635704757 | THRIVE MARKET | Food | Class I | 10 |
| 23 Jan 2019 | SATUR FARMS BABY SPINACH Retail product is packed in plastic clamshell containers with Satur Farms brand name: 5 oz, 10 oz, 16 oz Food service product is packed in sealed poly bags: 2-1/2 lbs, 3#, 4#, 4 x 2.5#, 4 x 3# | Satur Farms LLC | Food | Class I | 2 |
| 23 Jan 2019 | Gold Medal Unbleached All Purpose Flour. Net Wt 5 lb. (2.26kg). UPC 16000-19610. Distributed By General Mills Sales, Inc., Minneapolis, MN 55440 Cook Before Sneaking a Taste. Flour is Raw. Please Cook Fully Before Enjoying. | General Mills, Inc | Food | Class II | 1 |
| 22 Jan 2019 | Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 22 Jan 2019 | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | AtriCure, Inc. | Device | Class II | 4 |
| 22 Jan 2019 | Peaches, sold as a bulk retail item, with PLU 4044, and country of origin of Chile. The peaches sold at Aldi are packaged in a two pound bag with the brand Rio Duero, EAN# 7804650090281. | Jac Vandenberg Inc. | Food | Class I | 3 |
| 22 Jan 2019 | My Nanas Best Tasting Home Style-Estilo Casero Flour Tortillas Bakery Fresh. 24 oz (680g). Plastic bag (82016) | La Canasta Mexican Food Products, Inc. | Food | Class III | 1 |
| 21 Jan 2019 | Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and Up, NET WT 24 OZ (1.5 LB) 680g, UPC: 0 78742 06717 9 and Little JOURNEY Toddler Next Stage MILK DRINK POWDER, NET WT I PESO NETO 24 OZ I ONZAS (1.5 LB) 680g. | PBM Nutritionals, LLC | Food | Class II | 1 |
| 18 Jan 2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09 | Prinston Pharmaceutical Inc | Drug | Class II | 5 |
| 18 Jan 2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 18 Jan 2019 | Mrs GRISSOM'S SELECT OLD FASHIONED PIMENTO CHEESE**Mrs. GRISSOM'S SELECT CRANBERRY PECAN CHICKEN SALAD**INGREDIENTS: Sugar, Cider Vinegar, Water, Egg Yolks*** CONTAINS: Egg, Soy, Pecans (81962) | Individual firm, name withheld | Food | Class II | 1 |
| 17 Jan 2019 | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class I | 7 |
| 17 Jan 2019 | MEDTRONIC CARELINK 2090 programmer | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 2 |
| 17 Jan 2019 | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 1 |
| 16 Jan 2019 | daVinci Harmonic ACE Curved Shears | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Jan 2019 | Sysco Classic Liquid Margarine; 2 x 17.5 lb. plastic containers; 99961WFS | Ventura Foods Llc | Food | Class II | 1 |
| 15 Jan 2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23. | Tris Pharma Inc. | Drug | Class II | 3 |
| 14 Jan 2019 | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal. | 3M Company - Health Care Business | Device | Class II | 1 |
| 14 Jan 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. | Shimadzu Medical Systems Usa Com | Device | Class II | 1 |
| 14 Jan 2019 | Snak Club Praline Pecans Made With Cane Sugar NET Wt. 2.25 oz (64 g) Produced By: Century Snack Commerce, CA 90040 centurysnacks.com | Century Snacks LLC | Food | Class II | 1 |
| 11 Jan 2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86 (81914) | Oxalis Labs | Drug | Class III | 1 |
| 11 Jan 2019 | CTFO Sleep Support Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml. | Nutrafuels, Inc. | Food | Class II | 3 |
| 10 Jan 2019 | 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket. | Individual firm, name withheld | Device | Class II | 3 |
| 9 Jan 2019 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer… (81920) | NEUSOFT MEDICAL SYSTEMS IMP & EX | Device | Class II | 1 |
| 9 Jan 2019 | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients | Philips North America, LLC | Device | Class II | 9 |
| 9 Jan 2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 7 Jan 2019 | Pilling COOLEY SUMP-SUCTION TUBE, REF 351547 | Teleflex Medical | Device | Class II | 1 |
| 7 Jan 2019 | Chicago's Pizza Base Mix, Manufactured Exclusively for Chicago's Pizza, Greenfield, IN packaged in 30 lb bags. | Pizza Blends, LLC | Food | Class I | 10 |
| 4 Jan 2019 | LUNCH BOX SANDWICHES HAM & CHEESE CROISSANT; NET WT 5OZ (142G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67062 21217 2 | Grand Strand Sandwich Company,Inc. | Food | Class II | 3 |
| 4 Jan 2019 | Culinary Secrets, Butterscotch Instant Pudding Mix, Net Wt. 28 OZ, Marketed by Independent Marketing Alliance, Houston, TX, in paper pouches 12 per case | Diamond Crystal Brands, Inc. | Food | Class I | 11 |
| 4 Jan 2019 | HyVee brand cherry cheese cakes packaged in the following ways: 1) Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA UPC 02 80142 XXXXX packaged in clear plastic containers; 2) Cheesecake Family Size, Net Wt. 32 OZ, HyVee West Des Moines, IA 02 80141 XXXXX, packaged in clear plastic containers | Hy-Vee Stores Inc | Food | Class I | 16 |
| 4 Jan 2019 | ARDENT H&R SR FLR, 25LB, 50 LB, and 25LB (PC)-309951, packaged in paper bags, Store at Ambient Temperature | Ardent Mills, LLC | Food | Class II | 4 |
| 3 Jan 2019 | JB s Bun Blend 2.0, BT-1181811, Blend Tech Inc. Wichita, KS, packaged in 50 lb bags. (81906) | BlendTech, Inc. | Food | Class I | 1 |
| 3 Jan 2019 | Snak Club Tajin Chili & Lime Peanuts Mild 5 oz. Produced By: Century Snacks Commerice, CA 90040 centurysnacks.com UPC 0 87076 21640 5 | Century Snacks LLC | Food | Class II | 1 |
| 3 Jan 2019 | Clancy's Wavy Potato Chips, 10 oz., UPC 0 41498 16306 8 (81897) | Individual firm, name withheld | Food | Class I | 1 |
| 2 Jan 2019 | BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is… | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 31 Dec 2018 | IQF Red Raspberries, packed in flexible poly bags, net wt. 2 lbs. per bag. There are six bags packed per case. UPC is 0 22518 87750 9. The label of 2 lb. bag is read in parts: "***Red Raspberries ***WILLAMETTE VALLEY FRUIT ***Ingredients: Red Raspberries*** 2994 82nd Avenue NE Salem, OR 97305***PRODUCT OF USA***".… | Willamette Valley Pie Company, LLC. | Food | Class II | 1 |
| 28 Dec 2018 | GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and… | GE Healthcare, LLC | Device | Class II | 1 |
| 28 Dec 2018 | The Forest Wild Collection Dark Chocolate bar, CB15052, net wt. 1.25 oz per bar. Product is packaged in a card board box of 12 individually wrapped chocolate bars. Dream Chocolate brand, UPC on each bar is 6 76181 15088 1. Label has the wolf image. The label is read in parts: "***INGREDIENTS: Dark Chocolate (sugar,… (81885) | Salmon River Foods Inc | Food | Class I | 1 |
| 26 Dec 2018 | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic… | Luminex Corporation | Device | Class III | 1 |
| 26 Dec 2018 | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only | WEST PHARMA. SERVICES IL, LTD | Device | Class I | 3 |
| 26 Dec 2018 | ATLAS Loading Car | Steris Corporation | Device | Class II | 1 |
| 21 Dec 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are… | Edwards Lifesciences, LLC | Device | Class I | 4 |
| 21 Dec 2018 | Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 | Cook Inc. | Device | Class II | 1 |
| 21 Dec 2018 | New & Improved RTU Donut Glaze, NET WEIGHT 2800 lb. (1270 Kg) tote, UPC Codes: 608002213109, Product Code: 4110531 (81902) | Individual firm, name withheld | Food | Class I | 1 |
| 21 Dec 2018 | Dakota Specialty Milling Enhanced Flax Flour Blend, 42205, Net Wt 50 lbs. Ground Flax, Calcium Sulfate, inulin, VM 112 (vitamin mix flour enrichment containing Niacin, Iron, Vitamin B-1, Vitamin B-2, Folic Acid, Wheat Starch) | Dakota Specialty Milling, Inc | Food | Class I | 2 |
| 21 Dec 2018 | The Chocolate Therapist, Chocolate Rx, The Purist, 72% Natural Dark Chocolate, Net Wt 2oz (57g) (81824) | Chocolate Therapist, The | Food | Class I | 1 |
| 21 Dec 2018 | Terra Alba Food and Pharmaceutical Grade Hydrous Calcium Sulfate packaged in 50lb paper bags with inner plastic liner. (81871) | Individual firm, name withheld | Food | Class I | 1 |
| 21 Dec 2018 | 5-pound cans of unpasteurized, ready-to-eat, Dungeness crab meat, packaged in reduced oxygen metal cans that were shipped with Fresh-Check B Time Temperature Indicator (TTIs). Product was shipped frozen. The label is read in parts: "***BORNSTEIN SEAFOODS ***WILD Dungeness CRAB MEAT***INGREDIENTS: CRAB MEAT WITH SALT… | Bornstein Seafoods Inc | Food | Class I | 1 |
| 20 Dec 2018 | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 20 Dec 2018 | CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. (81857) | TERRIFIC CARE LLC | Device | Class I | 1 |
| 20 Dec 2018 | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this… | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Dec 2018 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10 | Akorn Inc | Drug | Class III | 1 |
| 20 Dec 2018 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | Torrent Pharma Inc. | Drug | Class II | 5 |
| 20 Dec 2018 | Nutty Choco Pop, 10 oz. bag. Sold in the following configurations: Item #101, Gift Box (contains 1-10 oz. bag), Item #1728 Holiday Crowd Pleaser (contains 5-10 oz. bags), and #9676 Crowd Pleaser (contains 5-10 oz. bags). (81860) | Funky Chunky LLC | Food | Class I | 1 |
| 20 Dec 2018 | Country Salad is a mixed product and it consists of Iceberg Lettuce, Romaine Lettuce, Shredded Carrots, Shredded Cabbage, and Sliced Radish. Products are cut or diced raw vegetables, packaged in vacuum sealed clear polybags, 5 pounds each, four packages per case. Product is sold under brand Apple Foods. This product… | Apple Foods, Inc. | Food | Class II | 5 |
| 19 Dec 2018 | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass… | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Device | Class II | 1 |
| 19 Dec 2018 | Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF… | XTANT MEDICAL INC | Device | Class II | 1 |
| 19 Dec 2018 | ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 (81872) | Individual firm, name withheld | Device | Class II | 1 |
| 19 Dec 2018 | Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 19 Dec 2018 | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). | Boston Scientific Corporation | Device | Class II | 1 |
| 19 Dec 2018 | Coconut Chocolate RXBARs , 1.83 oz., single bar, , 12-count carton, 5-count carton, 4-count carton | CHICAGO BAR COMPANY LLC RXBAR | Food | Class II | 19 |
| 18 Dec 2018 | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S | Wilson-Cook Medical Inc. | Device | Class II | 2 |
| 18 Dec 2018 | "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | Angiotech (Manan Medical Products, Inc.) | Device | Class II | 7 |
| 18 Dec 2018 | CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801 (81790) | LGM Pharma LLC | Drug | Class II | 1 |
| 17 Dec 2018 | Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended… | Roche Diagnostics Corporation | Device | Class II | 1 |
| 17 Dec 2018 | Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07 | Duren Health Mart Pharmacy | Drug | Class II | 6 |
| 17 Dec 2018 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684. | Promise Pharmacy, LLC | Drug | Class II | 51 |
| 17 Dec 2018 | Organic Sunflower Butter, Net Wt. 16 oz. (453g) Packaged under the following brand names: 1. Thrive Market, UPC 71635-70482. Manufactured for: Thrive Market - 4509 Glencoe Ave, Marina Del Rey, CA 90292. 2. Oskri, UPC 66016-40129 Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551 | Oskri Corp. | Food | Class I | 20 |
| 16 Dec 2018 | greens & Grains Hummus & Quinoa Tabouleh Wrap with lemon tahini dressing: Perishable: Keep Refrigerated Plastic container with tamper proof hinged lid Use by 12/19/18 Incorrect dressing was used: Label states: Dressing: Tahini (ground sesame seeds), Lemon Juice, Water, Pomace Olive Oil (refined pomace olive oil,… (81809) | Atherstone Foods, Inc. dba Glass Onion Catering | Food | Class I | 1 |
| 14 Dec 2018 | Italian Tapenade sandwich is Hoagie sandwich made with pepperoni, salami, capicola, cheese, Tapenade spread and green leaf lettuce. -Italian Tapenade or Italian Hoagie sandwich, 7.7 oz, UPC 88694 79803, Northwest Cuisine Creations brand. -Italian Tapenade or Italian Hoagie sandwich, 7.7 oz, UPC 88694 79803, Fresh &… | Spokane Produce Inc | Food | Class I | 12 |
| 13 Dec 2018 | MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 13 Dec 2018 | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A,… | Bard Medical Division | Device | Class II | 1 |
| 13 Dec 2018 | VITEK 2 AST-N351 Test Kit | bioMerieux, Inc. | Device | Class II | 1 |
| 13 Dec 2018 | Barley Lentil Dry soup base. UPC 91675-06002. the Secret Garden, Park Rapids, MN 56470 (81789) | The Secret Garden of Park Rapids, Inc. | Food | Class II | 1 |
| 11 Dec 2018 | VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 11 Dec 2018 | AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. | Baxter Healthcare Corporation | Device | Class II | 2 |
| 10 Dec 2018 | Genius Knee Cemented Tibial Component Product Usage: Knee replacement component | Signature Orthopedics Pty Limited | Device | Class II | 2 |
| 10 Dec 2018 | DrNatura Flora Protect¿ Probiotics | Mylan Pharmaceuticals Inc. | Food | Class II | 2 |
| 7 Dec 2018 | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22 | US Pharmaceuticals Inc. | Drug | Class II | 3 |
| 6 Dec 2018 | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine. | Bard Medical Division | Device | Class II | 1 |
| 5 Dec 2018 | DR. JACKSON'S RELAX TEA (ANTI-ANXIETY) 500mL Net Wt 49g; UPC Code: 5 060309 140239. Tea bags are packaged in a glass jar. (81813) | Individual firm, name withheld | Food | Class II | 1 |
| 4 Dec 2018 | Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904 | Randox Laboratories Ltd. | Device | Class II | 2 |
| 4 Dec 2018 | HomeFresh FOODS Suya Barbecue Seasoning, UPC: 6 033000120298, Net Wt: 240g/0.53 lbs; Produced in Ghana by: ELSSY KESS COMPANY LTD GHANA (81728) | Ellgof Inc. | Food | Class I | 1 |
| 29 Nov 2018 | OMNI K1 Broach Handle, Product Code HS-10054 | OMNIlife science Inc. | Device | Class II | 1 |
| 29 Nov 2018 | Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma | Ortho Clinical Diagnostics Inc | Device | Class II | 1 |
| 27 Nov 2018 | RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. | Medtronic Perfusion Systems | Device | Class II | 2 |
| 26 Nov 2018 | Soom Foods Tahini: Soom Sesame Premium Tahini, Single Source Origin, 100 % Roasted and Pressed Sesame Seeds, 11 oz. (6/case or 24/case) | Soom Foods | Food | Class I | 2 |
| 16 Nov 2018 | Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW (81782) | Ascension Orthopedics, Inc | Device | Class III | 1 |
| 12 Nov 2018 | SleepWorks Liquid Vitamin & Mineral Herbal Supplement 12 single serving bottles - 2 Fl Oz (60 mL) Net 24 Fl Oz (720 mL), product code W3721 (81764) | AdvoCare International, LP | Food | Class II | 1 |
| 7 Nov 2018 | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System | Philips Medical Systems Gmbh, DMC | Device | Class II | 1 |
| 1 Nov 2018 | Packer Apple Fresh Slices | Individual firm, name withheld | Food | Class II | 100 |
| 26 Oct 2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52 (81441) | Individual firm, name withheld | Drug | Class I | 1 |
| 25 Oct 2018 | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | The Magstim Company Limited | Device | Class II | 1 |
| 25 Oct 2018 | Barcelona Nut Company, Roasted and Salted Select Inshell Pistachios 21/25, flexible package, shelf life of one year. 2.75 oz., UPC 030239130001 with expiration date 9/18/2019 2.25 oz., UPC 030239149034 with expiration date 9/17/2019 and 10/9/2019 1.50 oz., UPC 030239591154 with expiration date 10/9/2019 and 9/17/2019… (81464) | Barcelona Nut Company | Food | Class I | 1 |
| 23 Oct 2018 | Katy's Kitchen Roasted and Salted Sunflower Kernals, Net Wt. 25 lbs, | Marathon Ventures Inc | Food | Class II | 1 |
| 18 Oct 2018 | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 17 Oct 2018 | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction… | Richard Wolf GmbH | Device | Class II | 1 |
| 12 Oct 2018 | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma. | Abbott Ireland Diagnostics Division | Device | Class II | 2 |
| 10 Oct 2018 | Naera Hospital Bassinet, Model No. 4402 | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 10 Oct 2018 | Meiqili Durian Candy in plastic bag with clear window, Net Wt: 12 ounce (340 g). It is a labeled as a product of P.R.C. and has a UPC code of 4-897055-795465-0. Sole Agent of U.S.A.: Fine Land Corp. (81733) | Fine Land Corp | Food | Class I | 1 |
| 8 Oct 2018 | Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10 | Akorn, Inc. | Drug | Class II | 1 |
| 26 Sep 2018 | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 4 |
| 11 Sep 2018 | Mimoso Queijo Minas Fresco Farmer's Cheese. Net Wt. 12 oz (340g) UPC 19753-00052 Keep Refrigerated. | Wisconsin Cheese Group, LLC | Food | Class II | 8 |
| 12 Jul 2018 | Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | GE Healthcare, LLC | Device | Class II | 1 |
| 2 Jul 2018 | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. | Radiometer America Inc | Device | Class II | 1 |
| 22 Jun 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509,… | Smiths Medical ASD Inc. | Device | Class II | 2 |
| 4 Apr 2018 | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY. (81459) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Jan 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user… | Riverpoint Medical, LLC | Device | Class III | 1 |
| 25 Sep 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 5 Sep 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Device | Class I | 13 |
| 2 Aug 2017 | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Haemonetics Corporation | Device | Class II | 2 |
| 12 Nov 2015 | tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560. (82112) | Mariposa Labs LLC | Drug | Class II | 1 |