| 15 Apr 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. Event 82652 | Iso-Tex Diagnostics, Inc | Drug | Class II | 1 |
| 12 Apr 2019 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 11 Apr 2019 | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA Event 82617 | Name withheld | Drug | Class II | 1 |
| 5 Apr 2019 | Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083. Event 82584 | Name withheld | Drug | Class I | 1 |
| 5 Apr 2019 | Diet Pepsi, Classic Diet Pepsi Taste; 12 fl. oz. cans; Sold in 6,12, 20, 24 and 36-packs 12-Pack UPC: 0 12000 17186 4: 20-Pack UPC: 0 12000 17184 0: 24-Pack Cube UPC: 0 12000 17185 7: 24-Pack Slab UPC: 0 12000 17178 9: 36-Pack UPC: 1 12000 17180 2 | Pepsico Inc | Food | Class III | 1 |
| 3 Apr 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30 | AVKARE Inc. | Drug | Class III | 1 |
| 3 Apr 2019 | Hunts Tomato Paste No Salt Added 6 ounce cans, 12 per wholesale tray Can UPC: 2700038807 Tray UPC: 2700038809 | ConAgra Foods, INc. | Food | Class II | 1 |
| 2 Apr 2019 | Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742. | Johnson Matthey Inc. | Drug | Class III | 1 |
| 2 Apr 2019 | Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Drug | Class II | 68 |
| 1 Apr 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 31 Mar 2019 | Breads from Anna Black Bean Brownie Mix 14oz, carton | Wholesome Treats, Inc. | Food | Class III | 5 |
| 30 Mar 2019 | NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert 16 ounce/pint packaged in a carton Event 82541 | LITTLE RED ROOSTER COMPANY | Food | Class I | 1 |
| 29 Mar 2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 29 Mar 2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1. | X-Gen Pharmaceuticals Inc. | Drug | Class III | 1 |
| 29 Mar 2019 | Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm name Prevent D Labs Division of CAYS, LLC Southington, CT Event 82570 | Cays LLC | Food | Class II | 1 |
| 28 Mar 2019 | Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 | Aurobindo Pharma USA Inc. | Drug | Class I | 1 |
| 28 Mar 2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16 | Akorn, Inc. | Drug | Class III | 1 |
| 28 Mar 2019 | Edamame Salad sold under the following labels: BOSTON SALADS Prepared Foods EDAMAME SALAD NET WT 5lb. KEEP REFRIGERATED AT 32-38 DEGREE FAHRENHEIT UPC 10611140153166; and Sensational EDAMAME SALAD NET WT WEIGHT 5 lb KEEP REFRIGERATED AT 32-40 DEGREES UPC 10022878100245 Event 82518 | Boston Salads & Provisions Co., Inc. | Food | Class II | 1 |
| 27 Mar 2019 | Sea Salt 70% Dark Chocolate 3 oz. bars, wrapped in foil and paper wrapper, brand Theo Chocolate, UPC 8 74492 00325 8. The Sea Salt 70% Dark Chocolate 3 oz. bar's label is read in part: "***Sea Salt 70% Dark Chocolate *** Ingredients: Cocoa Beans, Cane Sugar, Sea Salt, Ground Vanilla Bean *** Allergy Information:… Event 82507 | Theo Chocolate Inc | Food | Class I | 1 |
| 27 Mar 2019 | Blueberry Bread was sold as slices wrapped individually in food grade pastry bags, 3.7 oz net weight at retail shops. | Thomas Hammer Coffee Roasters, Inc. | Food | Class I | 3 |
| 26 Mar 2019 | Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18 Event 82567 | Medi-Physics Inc. dba GE Healthcare | Drug | Class III | 1 |
| 25 Mar 2019 | Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 25 Mar 2019 | Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01 | Lohxa LLC | Drug | Class II | 2 |
| 22 Mar 2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37. | InvaGen Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 22 Mar 2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630. Event 82483 | Auro Pharmacies Inc. DBA Central Drugs | Drug | Class III | 1 |
| 22 Mar 2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin… | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 22 Mar 2019 | Maika'i Sweet Honey Nut Snack Mix, Honey Sesame Sticks, Almonds, Pumpkin Seeds, Peanuts, Pistachios & Pecans. NET WT. 8 oz. (226) clear plastic bags; UPC: 6 18551 60132 6 Packed on shared equipment with peanuts, tree nuts, wheat, soy and milk. Distributed by Foodland Super Market, LTD. Honolulu, HI 96816 Event 82488 | Name withheld | Food | Class II | 1 |
| 22 Mar 2019 | Commercial Breader Batter; A28177 BATTER MIX X1; 50 pound bag | Newly Weds Foods Inc | Food | Class II | 31 |
| 21 Mar 2019 | syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 21 Mar 2019 | Wild Sweet ALLEN'S BLUEBERRIES WILD BLUEBERRIES IQF 30 LBS. NET 13.6 Kg. Packaged in a corrugated carton. Keep frozen at zero degrees F or below. Event 82467 | Allen's Blueberry Freezer, Inc. | Food | Class I | 1 |
| 21 Mar 2019 | Impossible Foods Bulk, 5 lb. vacuum sealed plastic-pack. Keep Frozen; This is a plant product that is looks like and is used like ground beef. UPC: (01) 00816697020036; Item # 60-00010 Event 82520 | Impossible Foods | Food | Class II | 1 |
| 21 Mar 2019 | Better Made Snack Foods Family Size $3.99 Original Potato Chips 10oz. flexible pouch bag UPC code of 041633063048 12 bags per case Event 82457 | Better Made Snack Foods Inc. | Food | Class II | 1 |
| 20 Mar 2019 | Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almonds, Peanuts, Pumpkin Seeds, Pistachios, Pecans & Honey Sesame Sticks. NET WET,3-oz. and 5.75-oz plastic pouches and 25 lb. bulk bags 3 oz. UPC: 0 87076 21152 3, 5.75 oz. UPC: 0 87076 51152 4 | Century Snacks LLC | Food | Class II | 1 |
| 19 Mar 2019 | BIOPHEN UFH Control C2, REF 223901 | Aniara Diagnostica LLC | Device | Class III | 3 |
| 19 Mar 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05 | Allergan Sales, LLC | Drug | Class II | 1 |
| 19 Mar 2019 | Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b)… Event 82396 | Name withheld | Drug | Class II | 1 |
| 19 Mar 2019 | Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsules; Dietary Supplement. Probiotic Blend 12.5 Billion CFU's L. rhamnosus HN001, L acidophilus La-14, L reuteri L.RE02. Other ingredients: Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate (vegetable source)/ Item Number: 981914 Product Number: WGNS… | Merical, LLC | Food | Class III | 1 |
| 18 Mar 2019 | Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems. | Roche Diagnostics Corporation | Device | Class II | 1 |
| 18 Mar 2019 | Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05. | Ingenus Pharmaceuticals Llc | Drug | Class III | 1 |
| 18 Mar 2019 | Nic's Peeled Pearls 20lb. Salad Grade Hard-Boiled Eggs NET WT. WHEN PACKED 20lbs Manufactured By: Almark Foods Gainesville, GA 30504 1.800.849.EGGS Event 82405 | Almark Foods Inc | Food | Class I | 1 |
| 15 Mar 2019 | Biomerieux Vitek 2 Test kit 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. | bioMerieux, Inc. | Device | Class II | 1 |
| 15 Mar 2019 | Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. | GE Healthcare, LLC | Device | Class II | 3 |
| 15 Mar 2019 | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022 | Estee Lauder Inc | Drug | Class III | 1 |
| 15 Mar 2019 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 | Pfizer Inc. | Drug | Class I | 1 |
| 15 Mar 2019 | Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 | Pfizer Inc. | Drug | Class III | 6 |
| 15 Mar 2019 | O Organics Organic Whole Strawberries; NET WT. 48 oz. (3 lb.) 1.36 kg UPC: 079893402758 Distributed by: Lucerne Foods, Pleasanton, CA 94566 Event 82423 | Nature's Touch Frozen Foods, LLC | Food | Class II | 1 |
| 14 Mar 2019 | Losartan 50mg Tablet, 30 count each blister card. | RemedyRepack Inc. | Drug | Class II | 1 |
| 14 Mar 2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0 Event 82419 | Ata International Inc | Drug | Class I | 1 |
| 13 Mar 2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 12 Mar 2019 | Azurion FlexArm, 722079 | Philips North America, LLC | Device | Class II | 1 |
| 12 Mar 2019 | VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO… | Ethicon, Inc. | Device | Class II | 3 |
| 12 Mar 2019 | Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with… | Elekta Limited | Device | Class II | 1 |
| 12 Mar 2019 | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures Event 82382 | Name withheld | Device | Class II | 1 |
| 12 Mar 2019 | 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3. | MSM Nutraceuticals, LLC | Drug | Class II | 4 |
| 12 Mar 2019 | Casa de Sante, Asafetida Powder Organic, 2.6 oz. (74g) 6 per package Event 82378 | Vanns Spices, Ltd | Food | Class II | 1 |
| 11 Mar 2019 | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack. | Johnson & Johnson Vision Care, Inc. | Device | Class II | 1 |
| 11 Mar 2019 | Quinoa, 16 oz plastic package Event 82347 | The Kroger Company | Food | Class III | 1 |
| 8 Mar 2019 | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct. | ulrich medical USA Inc | Device | Class II | 1 |
| 8 Mar 2019 | Olympus Diego Elite Console MDCONS 100 | Gyrus ACMI, Inc. | Device | Class II | 10 |
| 8 Mar 2019 | Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T | Integra LifeSciences Corp. | Device | Class II | 26 |
| 8 Mar 2019 | Fullei Fresh brand Organic Mung Bean Sprouts in a 4 oz. clear plastic clamshell container | Kwokcheng Enterprise, Inc. dba Fullei Fresh | Food | Class I | 1 |
| 8 Mar 2019 | Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper bag retail. 8 bags per shrink wrapped bale wholesale. UPC "0 5150022241 6" - retail unit UPC "0 5150022241 3" - wholesale bale | Hometown Food Company | Food | Class II | 1 |
| 7 Mar 2019 | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | Becton Dickinson & Company | Device | Class II | 1 |
| 7 Mar 2019 | FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 7 Mar 2019 | PL Trader Joe Natural Creamer - Vanilla 12/32oz, Plastic bottle, Distributed by Good Karma Foods, Inc. with manufacturing at Shamrock Foods at Phoenix, AZ., Keep refrigerated Event 82406 | GOOD KARMA FOODS INC | Food | Class II | 1 |
| 6 Mar 2019 | AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH). Event 82462 | PROCEPT BIOROBOTICS CORPORATION | Device | Class II | 1 |
| 6 Mar 2019 | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices… | Topcon Medical Systems, Inc. | Device | Class II | 1 |
| 5 Mar 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | Becton Dickinson & Company | Device | Class II | 2 |
| 5 Mar 2019 | LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com. Event 82336 | USA LESS Inc. | Drug | Class I | 1 |
| 4 Mar 2019 | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class III | 1 |
| 4 Mar 2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side. | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 4 Mar 2019 | Premium Sustainable Atlantic Salmon (Farm Raised); 22 lb. case - Master carton - corrugated cardboard box. Internal Packaging: IQF vacuum packed with tray. Origin: Chili Packed for Osamu Corporation, Carson, CA For institutional use only Event 82318 | Procesadora Aguas Claras LTDA. | Food | Class I | 1 |
| 2 Mar 2019 | Kid's Chocolate Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***KIDS CHOCOLATE COOKIES***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***MILK***SOY LECITHIN *** MODIFIED COCONUT OIL***EGGS ***". The… | Surtidoras Bakery Inc | Food | Class I | 9 |
| 1 Mar 2019 | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 1 Mar 2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot. | Integra Limited | Device | Class II | 3 |
| 1 Mar 2019 | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap… | Medical Action Industries Inc | Device | Class II | 1 |
| 1 Mar 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | Legacy Pharmaceutical Packaging LLC | Drug | Class II | 1 |
| 1 Mar 2019 | Snow's PREMIUM ICE CREAM Mint Chip Mint Ice Cream with Dark Chocolate Chunks 1.5 QUART (1.42L) KEEP FROZEN, UPCE: 0 48896400139 Event 82292 | Snow's Acquisition, LLC | Food | Class II | 1 |
| 28 Feb 2019 | Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 28 Feb 2019 | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas:… | Philips North America, LLC | Device | Class II | 5 |
| 28 Feb 2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | Torrent Pharma Inc. | Drug | Class II | 6 |
| 28 Feb 2019 | Host Defense MycoBotanicals Blood Sugar, dietary supplement, 500mg capsules, 60 ct per bottle, serving size 2 capsules per day. UPC: 6 33422 70474 6 (distributed in US) UPC: 8 22078 71303 9 (distributed in Canada) The product is labeled in parts: "***HOST DEFENSE MYCO BOTANICALS BLOOD SUGAR ***Made with Organic… Event 82297 | Fungi Perfecti LLC | Food | Class II | 1 |
| 27 Feb 2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30 | Cypress Medical Products LLC | Device | Class III | 1 |
| 27 Feb 2019 | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. | Brainlab AG | Device | Class I | 1 |
| 26 Feb 2019 | Abbott Alinity i Processing Module LN 03R65-01 - 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 microparticle immunoassay (CMIA) technology. CMIA technology is… | Abbott Gmbh & Co. KG | Device | Class II | 2 |
| 25 Feb 2019 | Bachman Original Twist Pretzels,10 oz.Bag (flexible film) UPC: 0-77817-10580-8 | Utz Quality Food Inc | Food | Class I | 1 |
| 22 Feb 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment… | GE Healthcare, LLC | Device | Class III | 1 |
| 22 Feb 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112 | Keystone Dental Inc | Device | Class II | 4 |
| 21 Feb 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of… | ICU Medical, Inc. | Device | Class I | 7 |
| 21 Feb 2019 | BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient… | Becton Dickinson & Co. | Device | Class II | 1 |
| 21 Feb 2019 | SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy | Drug | Class II | 25 |
| 20 Feb 2019 | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. | Abbott Laboratories | Device | Class II | 1 |
| 19 Feb 2019 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive… | Philips Medical Systems Nederlands | Device | Class II | 2 |
| 19 Feb 2019 | Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques.. Event 82248 | Name withheld | Device | Class III | 1 |
| 18 Feb 2019 | Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marrow | Avitus Orthopaedics, Inc. | Device | Class II | 2 |
| 15 Feb 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | COVIDIEN LLC | Device | Class II | 1 |
| 13 Feb 2019 | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH,… | Randox Laboratories Ltd. | Device | Class II | 1 |
| 13 Feb 2019 | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE. Event 82294 | Bioventus, LLC | Device | Class II | 1 |
| 13 Feb 2019 | Soom Chocolate Sweet Tahini Halva Spread 30 ml ( 1oz )Squeeze Pack Event 82189 | Soom Foods | Food | Class I | 1 |
| 12 Feb 2019 | e500 Automatic Transport Ventilator, Model Number 01EVE500 | O-Two Medical Technologies, Inc. | Device | Class I | 3 |
| 11 Feb 2019 | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. | Fenwal Inc | Device | Class II | 1 |
| 8 Feb 2019 | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails. | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 1 |
| 8 Feb 2019 | Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX | McDaniel Life-Line LLC | Drug | Class II | 2 |
| 7 Feb 2019 | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. | Cordis Corporation | Device | Class III | 1 |
| 7 Feb 2019 | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert | Randox Laboratories Ltd. | Device | Class III | 3 |
| 7 Feb 2019 | Frozen IQF Red Raspberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags 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***". The white… | Willamette Valley Pie Company, LLC. | Food | Class II | 2 |
| 6 Feb 2019 | Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150. | Advanced Bionics, LLC | Device | Class II | 3 |
| 6 Feb 2019 | LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes | LW Scientific, Inc. | Device | Class II | 3 |
| 6 Feb 2019 | Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. | Ecolab Inc | Drug | Class II | 5 |
| 4 Feb 2019 | Jacques Big Daddy Dark Chocolate Bar. The product comes in un-coded 2.2 lbs. (1kg) clear plastic package overwrapped with reddish brown paper label. Event 82208 | Jacques Torres Manufacturing , llc. | Food | Class II | 1 |
| 25 Jan 2019 | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access… | Medrobotics Corporation | Device | Class II | 2 |
| 25 Jan 2019 | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple… | Philips North America, LLC | Device | Class II | 1 |
| 17 Jan 2019 | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two… | CryoLife, Inc. | Device | Class II | 1 |
| 16 Jan 2019 | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 16 Jan 2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343 | KRS Global Biotechnology, Inc | Drug | Class II | 2 |
| 10 Jan 2019 | Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132 | Arrow International Inc | Device | Class II | 2 |
| 4 Jan 2019 | Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy. | Wilson-Cook Medical Inc. | Device | Class II | 1 |
| 4 Jan 2019 | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 | Conformis, Inc. | Device | Class II | 1 |
| 17 Dec 2018 | Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. | Roche Diagnostics Corporation | Device | Class II | 3 |
| 14 Dec 2018 | COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number :20767107322 - Product Usage: Tina-quant… | Roche Diagnostics Corporation | Device | Class II | 2 |
| 13 Dec 2018 | Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9 Event 81788 | ProThera, Inc. dba SFI USA | Food | Class II | 1 |
| 12 Dec 2018 | Jimmy's Original Blue Cheese Salad Dressing 15 Fl. Oz (443 ml). UPC 86824-22345 Keep Refrigerated. Manufactured by: Fish House Dressing, 1171 2nd Ave NE, Stewartville, MN 55976 Event 81786 | Fish House Dressing, Inc. | Food | Class III | 1 |
| 10 Dec 2018 | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate. | Smith & Nephew, Inc. | Device | Class II | 4 |
| 10 Dec 2018 | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin | ProSun International, LLC | Device | Class II | 2 |
| 6 Dec 2018 | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. | Vygon U.S.A. | Device | Class II | 2 |
| 5 Dec 2018 | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285. | Beckman Coulter Inc. | Device | Class II | 2 |
| 4 Dec 2018 | Modjeskas Bauer's Candies NET WT 8 oz, 12 oz, 16 oz, 32 oz. boxes & 4 oz, 8 oz bags, 400 pc case, 216 pc case | Bauer's Candies, Inc. | Food | Class II | 14 |
| 3 Dec 2018 | iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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… | Conformis, Inc. | Device | Class II | 1 |
| 30 Nov 2018 | BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures). Event 81757 | Name withheld | Device | Class II | 1 |
| 27 Nov 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO | ICU Medical, Inc. | Device | Class II | 3 |
| 21 Sep 2018 | CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. | DePuy Orthopaedics, Inc. | Device | Class II | 3 |
| 21 Sep 2018 | Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085 | Encore Medical, Lp | Device | Class II | 1 |
| 14 Sep 2018 | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours. | LivaNova USA Inc. | Device | Class II | 1 |
| 29 Aug 2018 | Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for… Event 81725 | SANRAI INTERNATIONAL LLC | Device | Class II | 1 |
| 23 Aug 2018 | Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Event 82477 | Pacific Compounding Pharmacy & Consultations Inc | Drug | Class II | 1 |
| 18 Jul 2018 | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. | Abbott Laboratories, Inc | Device | Class II | 2 |
| 17 Jul 2018 | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT… | Abbott Laboratories, Inc | Device | Class II | 3 |
| 3 Jul 2018 | Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 20 Apr 2018 | A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol Event 82531 | Pintler Medical LLC | Device | Class II | 1 |
| 5 Mar 2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742 | Johnson Matthey Inc. | Drug | Class II | 1 |
| 13 Mar 2017 | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing… | Accelerate Diagnostics Inc | Device | Class II | 1 |
| 26 Aug 2015 | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |