| 13 Aug 2021 | Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 1 |
| 10 Aug 2021 | Barbeque Marcelled Potato Chips Ballreich Snack Food Company 1.5, 2.5, and 7 ounce flexible plastic packaging 1.5 ounce/72 case, 2.75 ounce 32/case, 7 ounce 14/case Event 88466 | Ballreich Snack Food Company, LLC | Food | Class I | 1 |
| 9 Aug 2021 | Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice 6oz plastic container 36 packages per case Event 88458 | CB DISTRIBUTION LLC | Food | Class III | 1 |
| 9 Aug 2021 | Flavored Bacon Ranch Seasoning Packaged in 25lb kraft paper bags | Mane Inc | Food | Class I | 3 |
| 8 Aug 2021 | HiPP Comfort Milk Formula | Able Groupe Inc | Food | Class I | 21 |
| 5 Aug 2021 | Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | DuPont Nutrition USA, Inc | Drug | Class III | 1 |
| 4 Aug 2021 | MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED & DISTRIBUTED BY: MOLLY & ME PECANS LLC 9008 OLD… Event 88279 | Name withheld | Food | Class II | 1 |
| 4 Aug 2021 | Dark Chocolate Malt Balls in plastic container; 9 oz./ 255g UPC: 6 5143370179 0 Packed on the same equipment as products that contain milk, eggs, tree nuts, peanuts, wheat and soy. Distributed by DSD Merchandisers, Inc., Livermore, CA 64551 | DSD Merchandisers, Inc. | Food | Class I | 1 |
| 3 Aug 2021 | Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is read in parts: "***Moonwalk ***a 70% dark chocolate bar ***chocolate, cacao nibs and pop rocks ***Contents: cacao beans, cacao butter, cane sugar, pop rocks (sugar, lactose, corn… Event 88414 | Cocanu LLC | Food | Class II | 1 |
| 30 Jul 2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 | Noven Pharmaceuticals Inc | Drug | Class II | 2 |
| 30 Jul 2021 | Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837 | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy | Drug | Class II | 1 |
| 29 Jul 2021 | GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19 Event 88390 | Novel Laboratories, Inc. d.b.a LUPIN | Drug | Class II | 1 |
| 29 Jul 2021 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Drug | Class II | 3 |
| 29 Jul 2021 | Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 29 Jul 2021 | DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13 | Teva Pharmaceuticals USA | Drug | Class II | 19 |
| 26 Jul 2021 | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B | Philips Respironics, Inc. | Device | Class II | 4 |
| 26 Jul 2021 | Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4 Event 88310 | High Performance Formulas, L.L.C. (HPF, L.L.C.) | Drug | Class II | 1 |
| 26 Jul 2021 | McCormick Perfect Pinch Italian Seasoning 1.31 oz. Plastic Bottles, 36 packages per case; 2.25 oz. Plastic bottles, 6 packages per case | McCormick & Company - MSS - HQ | Food | Class I | 3 |
| 26 Jul 2021 | Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle Event 88354 | Monfefo LLC | Food | Class II | 1 |
| 23 Jul 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) | Boston Scientific Corporation | Device | Class II | 2 |
| 22 Jul 2021 | EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi | Philips Ultrasound Inc | Device | Class II | 1 |
| 21 Jul 2021 | MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391 | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 21 Jul 2021 | Old Souls Farm Arugula 5oz, 2lbs, and living oz are packed in clamshells - 1oz 18 per case, 5oz 6 per case lbs are packed in bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case | Old Souls Farms LLC | Food | Class I | 6 |
| 20 Jul 2021 | FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 20 Jul 2021 | Wickles Relish 16oz glass jars - 6 jars per case Event 88316 | Name withheld | Food | Class III | 1 |
| 19 Jul 2021 | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X | Cordis Corporation | Device | Class II | 1 |
| 19 Jul 2021 | Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. Event 88309 | Name withheld | Drug | Class II | 1 |
| 19 Jul 2021 | Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes. | Teligent Pharma, Inc. | Drug | Class II | 2 |
| 19 Jul 2021 | Organic Petite Carrots Brand name: Cal-Organic, 12 oz. (340g) plastic bag UPC: 0 7878390810 3 Organic Premium Petite Carrots; Brand name: Bunny Luv 3 lb. (1.36kg) bag; UPC: 0 7878351301 7 12 oz. plastic Bag -whole Foods 365 brand 12 oz. plastic bag - Whole Foods 365 brand - did not reach retail, destroyed at DC. | Grimmway Enterprises, Inc. dba Grimmway Farms | Food | Class I | 8 |
| 17 Jul 2021 | Marketside Strawberry & Creme Muffins - 14oz, 8 per case; UPC: 681131-41133 2 | GIVE AND GO PREPARED FOODS (USA) | Food | Class II | 26 |
| 16 Jul 2021 | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095 | Teleflex Medical Europe Ltd | Device | Class II | 4 |
| 16 Jul 2021 | f'real Made to Order Shake Base - 8 fl oz (237ml) cups Out packaging may read 'Smoothie-base' Lid may read ' Shake-base' 12 individual cups packed into a shrink-wrapped pulp tray | Rich Products Corp | Food | Class II | 1 |
| 16 Jul 2021 | Backcountry Dried Apricots 9ounce plastic bag 12 packages per case | Lipari Foods Operating Company, LLC. | Food | Class I | 1 |
| 15 Jul 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 | Cell Marque Corporation | Device | Class III | 1 |
| 15 Jul 2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01 | API Solutions Inc. | Drug | Class II | 2 |
| 15 Jul 2021 | Choujuki White Bread 6 slices: Net Wt. 13.9 oz. (374g) Ingredients: White Flour, Sugar, Margarine, Yeast Extract, Salt, Rice Flour, Vinegar. Contains Wheat. Keep Frozen at or below 18 degrees C Distributed by Hatsune JPN Inc., Torrance, CA Product of Japan/ Event 88276 | BLUE ROBINS INC | Food | Class II | 1 |
| 15 Jul 2021 | Amy's Bowls, Tortilla Casserole & Black Beans; Made with organic tomatoes & Black Beans. NET WT 9.5 oz. (269g); gluten Free - Perishable - keep frozen; UPC: 0 42272 00168 2 (individual box) Case UPC: 1-00-42272-00168-9 Microwave or regular oven. In trays with plastic overlay, inside cardboard boxes. 12 pack - 12… | Amys Kitchen Inc | Food | Class II | 1 |
| 14 Jul 2021 | Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled. | Maquet Medical Systems USA | Device | Class II | 1 |
| 14 Jul 2021 | smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery. Event 88311 | Smith & Nephew Orthopaedics Ltd. (Aurora) | Device | Class II | 1 |
| 14 Jul 2021 | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA Event 88334 | Ostial Corporation | Device | Class II | 1 |
| 14 Jul 2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com. Event 88280 | Qikmoov LLC | Drug | Class I | 1 |
| 12 Jul 2021 | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 12 Jul 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Stanbio Laboratory, LP | Device | Class III | 5 |
| 12 Jul 2021 | Now Real Food Organic Steel Cut Oats, 2 lb bag, code 6295, UPC 733739062956, packed 8 bags per case; case packaging is for Now Real Food Organic Beet Sugar 3lbs bags | NOW Health Group Inc. | Food | Class III | 1 |
| 9 Jul 2021 | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 Event 88272 | Name withheld | Device | Class II | 1 |
| 9 Jul 2021 | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free, | Ortho8, Inc. | Device | Class II | 2 |
| 9 Jul 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563 | Edwards Lifesciences, LLC | Device | Class II | 6 |
| 8 Jul 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds. | Sunrise Medical (US) LLC | Device | Class II | 2 |
| 8 Jul 2021 | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" | Carl Zeiss Meditec, Inc. | Device | Class II | 1 |
| 7 Jul 2021 | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Baxter Healthcare Corporation | Device | Class I | 1 |
| 7 Jul 2021 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 6 Jul 2021 | Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS Event 88281 | Advance Dx, Inc. | Device | Class II | 1 |
| 6 Jul 2021 | 5000 Years Foods SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars | 5000 Years Foods, Inc. | Food | Class II | 10 |
| 2 Jul 2021 | Blain's Farm & Fleet Select Dark Chocolate Amaretto Pecans, 12oz. | Eillien's Candies, Inc. | Food | Class I | 1 |
| 1 Jul 2021 | Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Jul 2021 | Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020). | Medline Industries Inc | Device | Class II | 4 |
| 1 Jul 2021 | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | Beckman Coulter Inc. | Device | Class II | 4 |
| 1 Jul 2021 | GlideScope Go Monitors | Verathon, Inc. | Device | Class III | 1 |
| 1 Jul 2021 | Vegetable egg rolls packaged either 96 3oz per case or 120 2oz per case, Manufacturer T&R Enterprises St. Louis MO. Event 88133 | T & R Enterprises USA, Inc. | Food | Class II | 1 |
| 30 Jun 2021 | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures Event 88367 | Hitachi Healthcare Americas Corporation | Device | Class II | 1 |
| 30 Jun 2021 | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system. | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 30 Jun 2021 | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210… | CooperSurgical, Inc. | Device | Class II | 1 |
| 30 Jun 2021 | Sharesource Connectivity Platform for Use with the Amia Automated PD System | BAXTER HEALTHCARE CORPORATION | Device | Class II | 2 |
| 30 Jun 2021 | Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery | Olympus Corporation of the Americas | Device | Class II | 1 |
| 30 Jun 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01 | Cascade Kelly Holdings LLC | Drug | Class II | 2 |
| 30 Jun 2021 | Chicken of the Sea Genova Meal Kit; Kits include dry whole wheat pasta, dried basil and parsley, 2 cans of Genova Tuna, pesto, Kalamata olives, sundried tomatoes, dates. Event 88218 | Chicken of the Sea; Thai Union | Food | Class II | 1 |
| 29 Jun 2021 | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. | Exactech, Inc. | Device | Class II | 2 |
| 29 Jun 2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01 | Eli Lilly & Company | Drug | Class II | 1 |
| 25 Jun 2021 | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | Richard Wolf GmbH | Device | Class II | 1 |
| 25 Jun 2021 | Infusomat Space Volumetric Pump Administration Set, Product Code 490100 | B. Braun Medical, Inc. | Device | Class II | 1 |
| 25 Jun 2021 | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm… Event 88174 | Name withheld | Device | Class II | 1 |
| 25 Jun 2021 | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | OPTI Medical Systems, Inc | Device | Class II | 1 |
| 25 Jun 2021 | Dole Fresh Picked-Emballes frais Blueberries/Bleuets: Packed in clear plastic container in the following sizes; 18 oz. - UPC: 0 71430 01154 6; Pint (16 oz.): UPC: 0 71430 01151 5; 6 oz. UPC: 07143001150 8; 24 oz. UPC: 071430011155 3 Distributed by Dole Berry Co, Winterhaven. FL Product of USA. Event 88183 | Dole Fresh Fruit Company | Food | Class II | 1 |
| 24 Jun 2021 | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic | Biomerieux Inc | Device | Class II | 1 |
| 24 Jun 2021 | Cooked, Peeled and Deveined, Tail-on, Shrimp. CENSEA, Frozen Cooked, peeled and deveined, Tail Off Shrimps IQF 2 LB Printed Polythene Pouch CHICKEN OF THE SEA, Frozen Cooked, peeled and deveined, Tail On Shrimps IQF with Cocktail Sauce 16oz Printed Polythene Trays HONEST CATCH, Frozen Cooked, peeled and deveined,… Event 88192 | Avanti Frozen Foods | Food | Class II | 1 |
| 23 Jun 2021 | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 23 Jun 2021 | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow… | Bard Peripheral Vascular Inc | Device | Class II | 3 |
| 23 Jun 2021 | Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA | Covidien Llc | Device | Class II | 1 |
| 22 Jun 2021 | MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. | BioMerieux SA | Device | Class II | 1 |
| 22 Jun 2021 | Del Monte Fresh Cut Golden Sweet Whole Kernel Corn; 15.25 oz. can (24 x 15.25 oz. cans per case) Case UPC – 10024000163029 Can UPC - 024000163022 Distributed by Del Monte Foods, Walnut Creek, CA | Del Monte Foods, Inc | Food | Class II | 1 |
| 21 Jun 2021 | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272 | Delta Med SpA | Device | Class II | 11 |
| 21 Jun 2021 | Eat GANGSTER, Oatmeal Schmoatmeal Cookie Mix, 8.5 Oz, Eat GANGSTER LLC, Wichita, KS, UPC 0 51497 13952 0 Event 88132 | Eat Gangster, LLC | Food | Class I | 1 |
| 18 Jun 2021 | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom | Remel Inc | Device | Class II | 1 |
| 16 Jun 2021 | Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201 | Cardinal Health 200, LLC | Device | Class I | 1 |
| 16 Jun 2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10 Event 88322 | Spirit Pharmaceuticals | Drug | Class II | 1 |
| 14 Jun 2021 | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer. | ROi CPS LLC | Device | Class II | 3 |
| 10 Jun 2021 | basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 10 Jun 2021 | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures | GE OEC Medical Systems, Inc | Device | Class II | 2 |
| 10 Jun 2021 | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569 | Abbott Laboratories | Device | Class II | 4 |
| 9 Jun 2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56 | Pfizer Inc. | Drug | Class II | 3 |
| 8 Jun 2021 | RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 8 Jun 2021 | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades | Philips North America Llc | Device | Class II | 5 |
| 7 Jun 2021 | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. | Medtronic Vascular, Inc. | Device | Class II | 2 |
| 4 Jun 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. | Baxter Healthcare Corporation | Device | Class I | 1 |
| 4 Jun 2021 | Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature. Event 87406 | Eight Medical International BV | Device | Class I | 1 |
| 4 Jun 2021 | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE | Device | Class II | 2 |
| 4 Jun 2021 | Paximune Dietary Supplement Contains Bovine Proteins that help Promote Health and help Modulate Immunity 2 Fl. Oz. (60ml) packaged in dark glass bottle 12 bottles per case UPC 64395 00001 Event 88151 | Bomunity Ltd Co | Food | Class II | 1 |
| 3 Jun 2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 3 Jun 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Heartware, Inc. | Device | Class I | 10 |
| 2 Jun 2021 | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000 Event 88160 | Name withheld | Device | Class II | 1 |
| 2 Jun 2021 | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300 | Biomet, Inc. | Device | Class II | 17 |
| 1 Jun 2021 | CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 28 May 2021 | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E | Hill-Rom, Inc. | Device | Class II | 1 |
| 27 May 2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S | Stryker GmbH | Device | Class II | 2 |
| 27 May 2021 | Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) | Cytocell Ltd. | Device | Class II | 1 |
| 27 May 2021 | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument. | Straumann USA LLC | Device | Class II | 1 |
| 26 May 2021 | Proteus 235-Proton Therapy System | Ion Beam Applications S.A. | Device | Class II | 1 |
| 25 May 2021 | OxyMask O2 Adult REF OM-1125-14 | Southmedic, Inc. | Device | Class II | 1 |
| 24 May 2021 | Solumeve Hydrolyzed Collagen Peptides, Turmeric + MCT and Ginger; Dietary Supplement, NET Wt. 14.1 oz. (400g) Suggested usage: Simply add 1 scoop (15.38 g) to a 6-8 fl oz. of room temperature water or juice once daily. UPC 8 98220 01828 4 Manufactured for Madre Labs, LLC 301 N. Lake Ave., #600 Pasadena, CA 91101 Event 88007 | IHERB LLC | Food | Class I | 1 |
| 21 May 2021 | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. | GE Healthcare, LLC | Device | Class II | 1 |
| 19 May 2021 | CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker | CooperVision Inc. | Device | Class II | 12 |
| 19 May 2021 | RANDALL GREAT NORTHERN BEANS 48OZ glass jar UPC 070095000100; RANDALL GREAT NORTHERN BEANS 24OZ glass jar UPC 070095000117; RANDALL GREAT NORTHERN BEANS 15.4OZ glass jar UPC 070095000131; RANDALL ORGANIC GREAT NORTHERN BEANS 48OZ glass jar UPC 070095005105; Hurst's Fully Cooked Great Northern Beans 48OZ glass jar UPC… | Randall Foods, Inc. | Food | Class II | 8 |
| 17 May 2021 | CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics | Cytocell Ltd. | Device | Class II | 1 |
| 12 May 2021 | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337 | W L Gore & Associates, Inc. | Device | Class II | 2 |
| 12 May 2021 | Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000 | Stryker Medical Division of Stryker Corporation | Device | Class II | 19 |
| 11 May 2021 | C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117 Event 88340 | People's Custom Rx and Clinical Care, LLC | Drug | Class I | 1 |
| 7 May 2021 | BUBS Naturals MCT OIL Powder, Medium Chain Triglycerides from 100% virgin Coconut Oil. Dietary Supplement 10.6 oz. Gusset Bags Event 87914 | Slayer Forever, LLC dba BUBS Naturals | Food | Class I | 1 |
| 21 Apr 2021 | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150… | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Device | Class II | 3 |
| 22 Mar 2021 | Spectrum Medical Quantum Standard heat exchanger Event 88267 | Name withheld | Device | Class II | 1 |
| 25 Feb 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410 Event 88170 | BioMedical Equipment Service Co (BMES) | Device | Class I | 1 |
| 12 Jan 2021 | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope | Shent USA, Inc. | Device | Class II | 2 |
| 23 Dec 2020 | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 | Tenderneeds Fertility LLC | Device | Class II | 9 |
| 3 Nov 2020 | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. Event 88307 | NEOSTEO | Device | Class II | 1 |
| 5 Oct 2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Med Shop Total Care Inc. | Drug | Class I | 14 |
| 21 May 2019 | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled “TDC Vitrectomy Pack VGPC 25g”, Product Number 8525.201. | Dutch Ophthalmic USA, Inc. | Device | Class II | 1 |
| 28 Dec 2017 | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Epimed International | Device | Class II | 2 |