| 19 Jul 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 19 Jul 2019 | Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ | Ascend Laboratories LLC | Drug | Class II | 1 |
| 19 Jul 2019 | MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. (83399) | Dercher Enterprises, Inc., DBA Gordon Laboratories | Drug | Class II | 1 |
| 18 Jul 2019 | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. (83358) | Medical Intelligence Medizintechnik Gmbh | Device | Class II | 1 |
| 18 Jul 2019 | 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38. | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 18 Jul 2019 | Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66. (83368) | Ucb, Inc | Drug | Class II | 1 |
| 18 Jul 2019 | Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) | Amneal Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 18 Jul 2019 | Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03. | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 18 Jul 2019 | Great Value Chopped Spinach, packed in poly bags, net wt. 12 oz. 12 oz. bag UPC: 0 78742 23740 4. master case UPC: 3 00 78742 23740 5. The retail 12 oz. bag label is read in parts: "*** Great Value Chopped Spinach ***INGREDIENTS: SPINACH *** DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 *** MICROWAVE… (83369) | National Frozen Foods Corporation | Food | Class II | 1 |
| 17 Jul 2019 | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions (83310) | LABORIE MEDICAL TECHNOLOGIES, CORP | Device | Class II | 1 |
| 17 Jul 2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 16 Jul 2019 | Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45. | Bionpharma Inc. | Drug | Class II | 1 |
| 16 Jul 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. | Deva Holding AS - Cerkezkoy Subesi | Drug | Class II | 6 |
| 16 Jul 2019 | Jelly Belly Licorice Bridge Mix. Net Wt. 9 oz. (85g); 12 individual 3 oz. bags per caddy UPC: 071567981675 Manufactured by Jelly Belly Co., Fairfield, CA 94533 (83317) | Individual firm, name withheld | Food | Class II | 1 |
| 16 Jul 2019 | Fruits Du Sud Golden Raisins, Golden Seedless Raisins, - Grade Medium Choice - Crop 2018 Net Weight 30LB (13.6KG), Production Date OCT 2018 Container Description: TRHU3994576 (83344) | FRUNUT GLOBAL COMMODITIES LLC | Food | Class I | 1 |
| 16 Jul 2019 | Top Chef Meals Grilled Bison Burger best used by date between 5/4/19-6/30/19 Unit Size: 6 and 8 oz sizes Container Description: Plastic PETE dual ovenable No specific UPC number (83347) | The Crystal Spoon Corp. | Food | Class I | 1 |
| 15 Jul 2019 | LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine,… (82857) | La Fresh Group, Inc. | Drug | Class II | 1 |
| 12 Jul 2019 | Wegmans Mini Ultimate Carrot Cake (Carrot Cake with Cream Cheese Frosting), 17oz, Sold in clear plastic cake clam shell, UPC Codes: 77890-79304 | Wegmans Food Markets, Inc. | Food | Class II | 5 |
| 11 Jul 2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Merge Healthcare, Inc. | Device | Class II | 2 |
| 11 Jul 2019 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. | Tris Pharma Inc. | Drug | Class II | 1 |
| 11 Jul 2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 9 Jul 2019 | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. | Pfizer Inc. | Drug | Class II | 2 |
| 9 Jul 2019 | DaVinci Laboratories of Vermont Omega 3-1,000 in a white bottle labeled as Dim Plex, 60 count UPC Code 026664273161 (83292) | FoodScience Corporation | Food | Class II | 1 |
| 9 Jul 2019 | BBQ Bread & Pull-A-Part BBQ Bread sold under the brand names of Flowers UPC 7 22500 40792, Ingles UPC 8 68540 15348 & Wonder UPC 7 22500 20923 | FLOWERS FOODS | Food | Class II | 12 |
| 9 Jul 2019 | PROBAR MEAL Chocolate Coconut, Net Wt. 3oz.(85g), Film wrapped bar | Probar LLC | Food | Class I | 6 |
| 4 Jul 2019 | Kroger Stuffed Mushrooms; Net Wt. 7 oz. (193 g) over-wrapped tray Perishable, Keep Refrigerated. Cook before consumption UPC: 2676614086 Distributed by Renaissance Food Group, LLC. 1730 Eastbridge Ave. Riverside, CA 92507 (83279) | GH Foods | Food | Class II | 1 |
| 3 Jul 2019 | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment. (83342) | Xcision Medical Systems, LLC | Device | Class II | 1 |
| 3 Jul 2019 | Salmon (Cut) | Topway Enterprises, Inc | Food | Class I | 2 |
| 2 Jul 2019 | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | GE Healthcare, LLC | Device | Class II | 2 |
| 1 Jul 2019 | Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench (83218) | Clariance Inc | Device | Class III | 1 |
| 28 Jun 2019 | MAC VU360, Model Number 2030360-001, Electrocardiograph | GE Healthcare, LLC | Device | Class II | 1 |
| 28 Jun 2019 | Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand] | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 28 Jun 2019 | Wilton Chocolate decorator icing stiff consistency 16 oz plastic tub retail unit 6 or 12 retail units per wholesale unit (83194) | Wilton Brands | Food | Class III | 1 |
| 28 Jun 2019 | Single Strength Apple Juice shipped in 5700 gallon tanker. The tanker label is read in parts: "***SINGLE STRENGTH APPLE JUICE ***VALLEY PROCESSING INC. SUNNYSIDE, WA *** O/TKR LUDFORD'S INC ***PO #53018VP-8 *** BRIX: 11.5 MIN***". (83249) | Valley Processing, Inc. | Food | Class II | 1 |
| 28 Jun 2019 | Pure Ground Ingredients Organic Fennel Seed, Ground 35 lb. bags Item # FENO-GR Processed and Packaged by: Pure Ground Ingredients 2535 Business Parkway Minden, NV 89423 | Individual firm, name withheld | Food | Class I | 2 |
| 28 Jun 2019 | OU Kosher Salted and Roasted Edamame Green Beans (Regular Salt), Packing: 2x11 lbs, Net WT: 22lbs, Product Of China (83237) | Ziba Nut Incorporated | Food | Class II | 1 |
| 26 Jun 2019 | Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | First Pharma Associates LLC dba Riverpoint Pharmacy | Drug | Class II | 18 |
| 26 Jun 2019 | Lisy Ground Cinnamon Canela Molida NET WT./CONT. NETO 13 OZ (368g) and 2 OZ (57g) (83238) | Individual firm, name withheld | Food | Class II | 1 |
| 26 Jun 2019 | Cheddar popcorn, bulk, packaged in metalized film, Net Wt. 4.85 lbs., Item No. 107065 (83232) | Weaver Popcorn Co. | Food | Class I | 1 |
| 24 Jun 2019 | RX Daytona, Model Nos. RX4040 and RX4041 | Randox Laboratories, Limited | Device | Class II | 2 |
| 24 Jun 2019 | Elekta Unity, Image-Guided Radiation Therapy System 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 a defined… | Elekta, Inc. | Device | Class II | 1 |
| 24 Jun 2019 | TAPSYSTEM Model 2A, REF 8002A (83173) | Cardiocommand Inc. | Device | Class III | 1 |
| 24 Jun 2019 | Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04 | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 2 |
| 24 Jun 2019 | White Cheddar 5906-KD is a non-GMO White Cheddar Cheese Blend dried cheese powder. Product was shipped in bulk bags, net wt 50 lbs. The product label is read in parts: "***WHITE CHEDDAR BLEND 5906KD *** Net Wt. 50 lbs. ***INGREDIENTS: CHEDDAR CHEESE (Pasteurized Milk, Salt, Cheese Culture, Enzymes), WHEY, BUTTER… (83212) | Commercial Creamery Company of Idaho, Inc. | Food | Class I | 1 |
| 21 Jun 2019 | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04. | Pharma-Natural Inc. | Drug | Class II | 16 |
| 20 Jun 2019 | Cios Alpha VA20/ VA30 mobile X-Ray systems | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 20 Jun 2019 | Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10 | Macleods Pharma Usa Inc | Drug | Class II | 5 |
| 20 Jun 2019 | Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468 | Perrigo Company PLC | Food | Class II | 1 |
| 20 Jun 2019 | Will's Fresh Foods Macaroni Salad, All Natural; A true Classic salad made astonishingly delicious - semolina pasta, real mayonnaise and crunchy vegetables; NET WT. 12 oz. (83196) | Woolery Enterprises Inc. dba Will's Fresh Foods | Food | Class II | 1 |
| 19 Jun 2019 | Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution. | Pharmaceutical Innovations, Inc. | Device | Class II | 5 |
| 19 Jun 2019 | WOODSTOCK ORGANIC GRILLED RED PEPPER, NET WT 10. OZ, packaged in a plastic packaged marked with UPC Code: 4256301714. Frozen. | UNFI General Corporate | Food | Class II | 1 |
| 18 Jun 2019 | LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120 | CooperSurgical, Inc. | Device | Class II | 1 |
| 18 Jun 2019 | DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack | DeRoyal Industries Inc | Device | Class II | 1 |
| 18 Jun 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia | Epimed International, Inc. | Device | Class II | 2 |
| 18 Jun 2019 | Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6. | Premier Pharmacy Labs Inc | Drug | Class II | 18 |
| 18 Jun 2019 | Signature Select Avocado Chunks, 12 oz. (340 g) Stand-up pouch Re-sealable, Keep Frozen; UPC 2113009412 Ingredient: Avocado Chunks, Key Lime Juice Distributed by Better Living Brands Pleasanton, CA Product of Peru, Packed in Canada (83160) | Nature's Touch Frozen Foods (West) | Food | Class I | 1 |
| 17 Jun 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use. | Datascope Corp. | Device | Class I | 6 |
| 17 Jun 2019 | The Grinch Sugar Cookie Mix with Sprinkles, 22.3 oz glass jar, 6/case | Brand Castle LLC | Food | Class I | 6 |
| 17 Jun 2019 | TAYLOR FARMS ORGANIC BABY SPRING MIX & BABY SPINACH LETTUCES - 5.5OZ PACKAGE, UPC: 0223047612 | C & S Wholesale Grocers, Inc. | Food | Class II | 330 |
| 16 Jun 2019 | Spicy Shrimp Tempura Crunch Roll, Mai brand, packed in container with clear plastic lid,net wt. 9.1 oz., UPC 8 12824 01526 5. The label is read in parts: "***MAI SPICY SHRIMP TEMPURA CRUNCH ROLL ***KEEP REFRIGERATED***Allergen: SOY, WHEAT, SHELLFISH***"dist by Mai Sushi 2 Penn Center, Suite 725, 1500 JFK Blvd… | Mai Cuisine LLC | Food | Class I | 2 |
| 14 Jun 2019 | STANLEY Healthcare Arial 54315 Network Manager | Stanley Security Solutions Inc | Device | Class II | 1 |
| 14 Jun 2019 | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical… | CooperSurgical, Inc. | Device | Class II | 2 |
| 14 Jun 2019 | Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 | Golden State Medical Supply Inc. | Drug | Class II | 4 |
| 14 Jun 2019 | Lay' Lightly Salted Barbecue Flavored Potato Chips Net Wt. 7 3/4 OZ. UPC Code 2840063242 | Frito-Lay, Inc. | Food | Class I | 1 |
| 14 Jun 2019 | Ragu Chunky Sauce Tomato, Garlic & Onion 45oz and 66oz retail sizes sold in plastic jars | Mizkan America, Inc. - Corporate | Food | Class II | 3 |
| 14 Jun 2019 | Ocean Supreme and Yaquina Bay IQF shrimp meat, product of USA wild caught, cooked and peeled, 5 lb. bag, 4/5 lb. bags per box, net wt. 20#. The BAG label is read in parts: "***Ocean Supreme *** Cooked & Peeled I.Q.F SHRIMP MEAT ***Ingredients: Shrimp Meat and Salt ***Net Wt. 5 lbs. *** Packed By Hallmark Fisheries,… (83162) | California Shellfish, Inc. dba Hallmark Fisheries | Food | Class II | 1 |
| 14 Jun 2019 | Sprouts Farmers Market Cut Leaf Spinach, Net Wt 16 Oz (1 lb), 453 g, Manufactured exclusively for Sprouts Farmers Market, Phoenix, AZ UPC 8 74875 00982 2, packaged in plastic bags, 12 bags per case. | Sprout's Farmers Market | Food | Class II | 2 |
| 13 Jun 2019 | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) | SpineFrontier, Inc. | Device | Class II | 1 |
| 13 Jun 2019 | Gordon CHOICE Whole Strawberries; 5lb bags; UPC Code 93901 24463 5 (83111) | B.C. Frozen Foods | Food | Class II | 1 |
| 13 Jun 2019 | Frozen whole Red Raspberries; packed in a 12 oz. polyethylene bag; UPC: 0 70552 30501 4. The label is read in parts: "***WinCo Foods Red Raspberries *** KEEP FROZEN***PRODUCT OF USA***DISTRIBUTED BY: WINCO FOODS LLC, BOISE, ID***". | Oregon Potato Company | Food | Class II | 1 |
| 12 Jun 2019 | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to… | ZOLL Medical Corporation | Device | Class II | 1 |
| 12 Jun 2019 | AXIOM Artis FC, Model Number 5904433 | Siemens Medical Solutions USA, Inc | Device | Class II | 23 |
| 12 Jun 2019 | Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44 | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 12 Jun 2019 | 70% Dark Chocolate Buttons packaged in cellophane bags, zip bags (plastic bag with Ziploc closure), a bulk bin in the factory store. Net wt. 3 oz., 8 oz., 16 oz., 3 lbs (48 oz.) UPC on 3 oz. bag: 0 50469 05423 UPC on 8 oz. bag: 0 50469 05424 or 0 50469 05497 UPC on 16 oz. bag: 0 50469 05117 or 0 50469 05495 UPC on 48… (83106) | Euphoria Trading Company, LLC. | Food | Class II | 1 |
| 10 Jun 2019 | Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 10 Jun 2019 | BrightView SPECT, Model Number 882480 | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 10 Jun 2019 | Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 10 Jun 2019 | Food starch, brand names Miraqk Mgl and Nustar 120 and Nustar 140 (83176) | Tate & Lyle Ingredients Americas, LLC | Food | Class III | 1 |
| 7 Jun 2019 | Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | Philips North America, LLC | Device | Class II | 1 |
| 7 Jun 2019 | Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78 | PharMEDium Services, LLC | Drug | Class I | 1 |
| 7 Jun 2019 | Parivar brand Dry Dates (Kharek) Net Wt.14 oz. (400 g) Product of India Batch No. 127/BHBI (83087) | DILIP CERAMICS DBA SHIVAM DISTRIBUT | Food | Class I | 1 |
| 6 Jun 2019 | Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135 | Siemens Medical Solutions USA, Inc | Device | Class II | 12 |
| 6 Jun 2019 | LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00 | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 5 Jun 2019 | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters… | GETINGE US SALES LLC | Device | Class II | 1 |
| 5 Jun 2019 | Soy Sauce, 10 FL OZ (83072) | Baumer Foods Inc | Food | Class I | 1 |
| 4 Jun 2019 | Powerheart¿ G5 Automatic AED (83103) | Cardiac Science Corporation | Device | Class II | 1 |
| 4 Jun 2019 | SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 4 Jun 2019 | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 4 Jun 2019 | Full Circle Market Garden Style Salsa, Mild, Net Wt 16 oz, in jars, 8 jars per case. | Simply Fresco LLC | Food | Class II | 2 |
| 3 Jun 2019 | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. | Roche Diagnostics Corporation | Device | Class II | 1 |
| 3 Jun 2019 | Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 3 Jun 2019 | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC… | Becton Dickinson & Company | Device | Class II | 1 |
| 3 Jun 2019 | Raw fresh whole jalapeno, ambient Non-descript 10# cardboard box. Sold as 10lb unit or by the pound. (83071) | Shelton Farms dba Shelton's Wholesale Co | Food | Class I | 1 |
| 31 May 2019 | CLEO Patient Monitor /Tranquility VS Patient Monitor (82999) | Infinium Medical, Inc | Device | Class II | 1 |
| 31 May 2019 | REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. | Baxter Healthcare Corporation | Device | Class II | 2 |
| 31 May 2019 | Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04 | Geritrex, LLC | Drug | Class II | 8 |
| 31 May 2019 | Plain Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117 | Hank's Cheesecakes, LLC | Food | Class II | 23 |
| 31 May 2019 | Great Value Blackberries NET WT 16 OZ (1 LB) 454g bags DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 KEEP FROZEN UPC 0 78742 43101 7 | Riverside Foods Llc | Food | Class II | 2 |
| 30 May 2019 | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY… | Medline Industries, Inc. | Device | Class II | 1 |
| 29 May 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible,… | AtriCure, Inc. | Device | Class II | 1 |
| 29 May 2019 | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072 | Zyno Medical LLC | Device | Class II | 2 |
| 28 May 2019 | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) | Bio-Detek, Inc. | Device | Class II | 1 |
| 28 May 2019 | SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 28 May 2019 | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist… | Datascope Corporation | Device | Class II | 1 |
| 28 May 2019 | DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma. | Zimmer Biomet, Inc. | Device | Class II | 3 |
| 28 May 2019 | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter. | InfuTronix LLC | Device | Class II | 1 |
| 28 May 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 13 |
| 28 May 2019 | ACID RAIN ASS KICKING FAT DESTROYER APOCALYPSE LABZ; 45 CAPSULES; 1 DIETARY SUPPLEMENT; UPC 6 11138 28792 0 (82853) | Nexagen, LLC | Food | Class II | 1 |
| 24 May 2019 | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. | Abbott Laboratories | Device | Class III | 2 |
| 24 May 2019 | Stagno's Bakery, Inc., P006, Blueberry Bagel , Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen | Stagno's Bakery, Inc. | Food | Class II | 10 |
| 23 May 2019 | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with… | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 22 May 2019 | Baker's Corner All Purpose Flour 5 lb. bag UPC code: 041498130404 | Individual firm, name withheld | Food | Class I | 20 |
| 22 May 2019 | Classic Salads 5067PF Baby Greens Conv NordicBlend 4x3# Pillow Pack Peak Fresh 344; 5067 Baby Green Conv NordicBlend 4x3# Pillow Pack Classic 344 3 lb bags; Brand names of Peak Fresh and Classic Salads (82943) | Classic Salads, LLC | Food | Class I | 1 |
| 21 May 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. | Medtronic Inc | Device | Class II | 5 |
| 20 May 2019 | Blue Plate Light Olive Oil Mayonnaise 30oz / 18oz, PET jars and PET squeeze bottles | Reily Foods Co., Inc | Food | Class III | 2 |
| 17 May 2019 | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: 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… | GE Healthcare, LLC | Device | Class II | 2 |
| 16 May 2019 | Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | GE Healthcare, LLC | Device | Class II | 2 |
| 15 May 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Ethicon Endo-Surgery Inc | Device | Class II | 3 |
| 15 May 2019 | Karawan, 100% Raw Ethiopian Sesame Seeds, Net Weight: 17 Kg (599.6 oz) | Brodt Zanatti Holding Llc | Food | Class I | 4 |
| 15 May 2019 | GlutaDose 400 mg Antioxidant & Immune Detox 30 day supply Dietary Supplement Oral Solution Citric Flavor (82892) | BioDose Pharma, LLC | Food | Class II | 1 |
| 13 May 2019 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25 | American Health Packaging | Drug | Class II | 4 |
| 10 May 2019 | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN… | GE Healthcare, LLC | Device | Class III | 5 |
| 10 May 2019 | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings.… | Phadia Ab | Device | Class II | 1 |
| 10 May 2019 | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be… | Teleflex Medical | Device | Class I | 1 |
| 9 May 2019 | Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories | American Health Packaging | Drug | Class II | 1 |
| 8 May 2019 | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z | Individual firm, name withheld | Device | Class II | 2 |
| 6 May 2019 | RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular… (82985) | Qiagen Sciences, Inc. | Device | Class II | 1 |
| 6 May 2019 | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000… | Becton Dickinson & Company | Device | Class I | 1 |
| 3 May 2019 | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 2 May 2019 | Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and… (83023) | Rinovum Women's Health | Device | Class II | 1 |
| 1 May 2019 | Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R… | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 30 Apr 2019 | Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 | Cardinal Health 200, LLC | Device | Class II | 17 |
| 29 Apr 2019 | MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011… | COVIDIEN LLC | Device | Class II | 1 |
| 15 Apr 2019 | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. (83056) | Hitachi America, Ltd., Power Systems Division | Device | Class II | 1 |
| 12 Apr 2019 | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. | Tecan US, Inc. | Device | Class II | 1 |
| 8 Apr 2019 | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides. | Ortho-Clinical Diagnostics | Device | Class II | 4 |
| 4 Apr 2019 | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval. | Roche Diagnostics Corporation | Device | Class III | 2 |
| 2 Apr 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05 | Thermo Fisher Scientific (Asheville) LLC | Device | Class II | 9 |
| 25 Mar 2019 | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care… | Hamilton Medical AG | Device | Class I | 1 |
| 15 Mar 2019 | Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open… | GE Healthcare, LLC | Device | Class I | 2 |
| 13 Mar 2019 | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. | Vyaire Medical | Device | Class I | 2 |
| 28 Feb 2019 | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 | Becton Dickinson & Company | Device | Class I | 1 |
| 27 Feb 2019 | MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural,… | Zevex Incorporated (dba MOOG Medical Devices Group) | Device | Class II | 2 |
| 8 Feb 2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | Terumo Medical Corporation | Device | Class II | 9 |
| 1 Feb 2019 | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | Becton Dickinson & Company | Device | Class II | 2 |
| 29 Jan 2019 | TASE 400 Imaging systems | Individual firm, name withheld | Device | Class II | 2 |
| 28 Jan 2019 | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. | Spacelabs Healthcare, Inc. | Device | Class II | 1 |
| 28 Jan 2019 | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to… | Applied Medical Resources Corp | Device | Class II | 1 |
| 19 Jan 2019 | Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | GE Healthcare, LLC | Device | Class II | 1 |
| 17 Jan 2019 | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. | DJO, LLC | Device | Class II | 1 |
| 14 Jan 2019 | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device | Teleflex Medical | Device | Class III | 2 |
| 10 Jan 2019 | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A. | Bio-Rad Laboratories, Inc | Device | Class II | 1 |
| 10 Jan 2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152. | MAJOR PHARMACEUTICALS | Drug | Class II | 1 |
| 5 Dec 2018 | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 | Medela Inc | Device | Class III | 1 |
| 18 Oct 2018 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany. | Beckman Coulter Inc. | Device | Class II | 1 |
| 16 Oct 2018 | Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors… | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 24 Sep 2018 | Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use) | Johnson & Johnson Surgical Vision Inc | Device | Class II | 1 |
| 18 Sep 2018 | Sorghum, Mfg. by Ozark Country Sorghum, Dunnegan, MO 65640, Net Wt. 2 lb. 14 OZ. packaged in glass jars (81048) | Ozark Country Kitchen | Food | Class II | 1 |
| 17 Sep 2018 | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year… | Beckman Coulter Inc. | Device | Class II | 1 |
| 8 Aug 2018 | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | Helena Laboratories, Corp. | Device | Class II | 2 |
| 25 Jun 2018 | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 16 May 2018 | C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604… | Abbott Laboratories, Inc | Device | Class II | 9 |
| 13 Apr 2018 | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism… | CareFusion 303, Inc. | Device | Class I | 1 |
| 20 Nov 2017 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 25 Sep 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01 | Amneal Pharmaceuticals, Inc. | Drug | Class III | 2 |
| 1 Sep 2016 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 (83281) | CellEra LLC | Device | Class II | 1 |