| 29 Aug 2024 | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder | Tornier, Inc | Device | Class II | 1 |
| 29 Aug 2024 | Asli Cinnamon Powder, 7oz clear plastic pouch, UPC 703440150723 Event 95280 | Sands Impex Inc. Dba Asli Fine Foods | Food | Class II | 1 |
| 28 Aug 2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4 Event 95250 | Name withheld | Drug | Class II | 1 |
| 27 Aug 2024 | HAWK Warming Grid, Item Number: 59-300 | Safeguard US Operating LLC | Device | Class II | 3 |
| 26 Aug 2024 | a.) Great Value 8oz Apple Juice in 6pack; PET plastic bottle b.) Great Value 96oz Apple Juice; PET plastic bottle c.) Market Basket 100% apple juice; 64 oz; PET plastic bottle d.) Nice! 100% apple juice ; 64 oz; PET plastic bottle e.) Weis 100% apple juice; 64 oz; PET plastic bottle f.) Urban Meadow 100% apple juice;… | Refresco Beverages US Inc | Food | Class II | 1 |
| 26 Aug 2024 | KODIAK PROTEIN-PACKED POWER WAFFLES BUTTERMILK & VANILLA NET WT 3.35 lb (53.6oz) 1.52kgCreated & distributed by: KODIAK CAKES PARK CITY, UT 84098 UPC 7 05599 01920 3 Event 95236 | KODIAK CAKES LLC | Food | Class II | 1 |
| 24 Aug 2024 | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01 | Rubicon Research Private Limited | Drug | Class III | 1 |
| 23 Aug 2024 | Wegmans PECAN BLEND NET WT 16OZ (1LB) 453g Ingredients: Pecans, Cashews, Pistachios, Canola and/or Peanut and/or Cottonseed Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPC 0 77890 31040 3 | Flagstone Foods LLC | Food | Class II | 1 |
| 22 Aug 2024 | System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 4 |
| 22 Aug 2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01 | ProRx LLC | Drug | Class II | 7 |
| 22 Aug 2024 | American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, or 160 count cases. One unit is also included in the Outerspace Survival Dessert Kit. Shelf stable. Event 95255 | American Outdoor Products, Inc. | Food | Class II | 1 |
| 22 Aug 2024 | Terrafina Golden Raisins Net Wt. 10oz (283g) UPC:847938001385. Packaged in a plastic container, 8 containers per case. | SUNCO & FRENCHIE LLC. | Food | Class I | 1 |
| 22 Aug 2024 | Bliss Tree Ragi Butter Murukku 200g UPC:8906087451754. Packaged in a box, 13 boxes per case Bliss Tree Ragi Butter Murukku 400g UPC:8906087452829. Packaged in a pouch, 8 pouches per case | Name withheld | Food | Class I | 6 |
| 21 Aug 2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 21 Aug 2024 | Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue Raspberry and Grape flavored. GTIN/UPC 10077567003727 Case UPC 77567003720 Event 95191 | Unilever North America Supply Chain Company, LLC | Food | Class I | 1 |
| 21 Aug 2024 | BDAY CAKE MOCHI CRUNCH packed in pink plastic pouch packaging, net wt. 5oz, UPC 7189147148, Orwaiian LLC, 465 NE Burnside Rd Gresham, OR 97030. The label declares "***Ingredients: Sesame Seeds, Milk Powder, Nonfat dry milk, Soy Lecithin, Coconut ***CONTAINS: Soy, Sesame ***MANUFACTURED in a facility that also… Event 95244 | Orwaiian LLC | Food | Class II | 1 |
| 20 Aug 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device | Baxter Healthcare Corporation | Device | Class I | 4 |
| 20 Aug 2024 | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | Cypress Medical Products LLC | Device | Class II | 2 |
| 20 Aug 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1 Event 95219 | Elevate Oral Care | Drug | Class III | 1 |
| 16 Aug 2024 | Nuts.com Paprika 25 lb, packaged in a clear plastic bag. 1 bag per cardboard box. Event 95184 | Name withheld | Food | Class I | 1 |
| 16 Aug 2024 | El Servidor Corp Ground Cinnamon Net Wt. 1.5 oz. UPC: 745245113244. Packaged in clear plastic bag. 12 bags per case. Gutierrez Distributor Canela Molida Ground Cinnamon 1.5 oz. UPC: 852705000164 Packaged in clear plastic bag. Event 95048 | Gutierrez Distributors, LLC | Food | Class II | 1 |
| 15 Aug 2024 | Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 15 Aug 2024 | Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system | CareFusion 303, Inc. | Device | Class II | 5 |
| 15 Aug 2024 | SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095 | B Braun Medical Inc | Device | Class II | 7 |
| 14 Aug 2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in… | Innovasis, Inc | Device | Class II | 1 |
| 14 Aug 2024 | NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128 | Now Foods | Food | Class II | 1 |
| 13 Aug 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 | Zoe Medical Incorporated | Device | Class II | 2 |
| 12 Aug 2024 | Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires,… Event 95138 | SEER MEDICAL PTY LTD | Device | Class II | 1 |
| 12 Aug 2024 | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1 | Smith & Nephew Inc. | Device | Class II | 2 |
| 12 Aug 2024 | 6.5oz Emerald Kettle Glazed Walnut, UPC: 0 10300 80894 7 | Flagstone Foods, LLC | Food | Class II | 1 |
| 9 Aug 2024 | Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, Canola Oil), Food Starch-Modified, Baking Powder (Corn Starch, Sodium Bicarbonate, Sodium Aluminum Sulfate, Monocalcium Phosphate),… | Prime Food Processing Corp. | Food | Class I | 2 |
| 8 Aug 2024 | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 8 Aug 2024 | Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066 | Zimmer GmbH | Device | Class II | 2 |
| 8 Aug 2024 | AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036 | B. Braun Medical, Inc. | Device | Class II | 1 |
| 8 Aug 2024 | ViewPoint; system, imaging processing, radiological | GE Healthcare GmbH | Device | Class II | 2 |
| 8 Aug 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 8 Aug 2024 | Yummy Monkey Organics Butter & Yeast Popcorn, Made With Purified Ghee & Nutritional Yeast. UPC 9 96692 66641 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9 x 12 x 2". Net Wt: 5.25 oz (149g). Manufactured By: Yummy Monkey Organics, LLC 243 Grimes St. Ste. E, Eugene, OR. | Kester Foods LLC | Food | Class II | 2 |
| 7 Aug 2024 | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W | BioFire Diagnostics, LLC | Device | Class II | 2 |
| 7 Aug 2024 | Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U | B Braun Medical Inc | Device | Class I | 1 |
| 6 Aug 2024 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 6 Aug 2024 | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C | Cypress Medical Products LLC | Device | Class II | 1 |
| 6 Aug 2024 | IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle. | Name withheld | Drug | Class II | 3 |
| 5 Aug 2024 | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 5 Aug 2024 | Impella CP Smart Assist Set, EU; Product Code: 0048-0014; | Abiomed, Inc. | Device | Class II | 18 |
| 5 Aug 2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke. | MICROVENTION INC. | Device | Class II | 1 |
| 5 Aug 2024 | CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578 | PBM Nutritionals, LLC | Food | Class II | 1 |
| 2 Aug 2024 | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m average particle… | Ultradent Products, Inc. | Device | Class II | 3 |
| 2 Aug 2024 | Yummy brand Swirly Ices Tropical Tornado flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007567. Also packaged in 30 count packs | PARADISE DISTRIBUTORS, LLC | Food | Class I | 5 |
| 2 Aug 2024 | UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case. | Reser's Fine Foods, Inc. | Food | Class II | 6 |
| 1 Aug 2024 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion. | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 1 Aug 2024 | Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment Event 95233 | Btt Health Gmbh | Device | Class II | 1 |
| 1 Aug 2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04 | Baxter Healthcare Corporation | Drug | Class I | 1 |
| 1 Aug 2024 | Bikano Moong Dal Crunchy Green Gram Net Weight 12.35oz (350g) Product of India Manufactured by: Bikanervala Foods Pvt. Ltd. B1-Plot No. 42 (Khasra No. 661-662), Ecotech II, Udyog Vihar, Greater Noida Gautam Buddha Nagar - 201306 Event 95095 | Thal Golden Spices Inc. | Food | Class I | 1 |
| 1 Aug 2024 | J-Basket Brand, Napa Kimchi, Net Wt. 14.1oz. plastic jar container (12 jars per case). | J F C International Inc | Food | Class II | 1 |
| 31 Jul 2024 | Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010,… | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 30 Jul 2024 | Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Jul 2024 | Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Marcum brand ground cinnamon packaged in 1.5 oz clear plastic jars with black lids. UPC:051933364035 | Colonna Brothers Inc. | Food | Class II | 1 |
| 30 Jul 2024 | Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged. Event 95086 | WR Coffee Inc | Food | Class II | 1 |
| 29 Jul 2024 | DR 800. Digital Radiography X-ray System. Event 95115 | Name withheld | Device | Class II | 1 |
| 29 Jul 2024 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 29 Jul 2024 | Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper carton | MAMTAKIM, Inc. | Food | Class II | 1 |
| 29 Jul 2024 | Item 41303.82013, Reser's Essential Everyday Original Potato Salad, refrigerated product, net wt. 16oz. There are 6 packs per case. | Reser's Fine Foods, Inc. | Food | Class II | 14 |
| 29 Jul 2024 | La Superior Bakery - Pan De Rancho packaged in clear plastic bag - 5 pastries per bag | La Superior Bakery | Food | Class II | 2 |
| 26 Jul 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003; | Beaver Visitec International, Inc. | Device | Class II | 159 |
| 26 Jul 2024 | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 5 |
| 26 Jul 2024 | BiomarC EX Fiducial Marker System, Catalog Number 040165 Event 95179 | Carbon Medical Technologies, Inc. | Device | Class III | 1 |
| 25 Jul 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216) | Breas Medical, Inc. | Device | Class I | 1 |
| 25 Jul 2024 | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 Event 95188 | Name withheld | Device | Class II | 1 |
| 25 Jul 2024 | ALB Flavor brand CINNAMON Powder; 100 g; ALB-USA Enterprises Inc 529 Bryant Av, Bronx, NY 10474; UPC 5 304000 333362; packaged in a plastic bag inside a brown carton box with an image of cinnamon powder and two cinnamon sticks centered at the bottom. Event 95058 | Alb-USA Enterprises Inc | Food | Class II | 1 |
| 24 Jul 2024 | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 Event 95074 | Schiller, Ag | Device | Class II | 1 |
| 24 Jul 2024 | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS) | Cypress Medical Products LLC | Device | Class II | 1 |
| 24 Jul 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 | ROi CPS LLC | Device | Class II | 1 |
| 24 Jul 2024 | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | Device | Class I | 1 |
| 24 Jul 2024 | Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref:… | Stryker Corporation | Device | Class II | 10 |
| 23 Jul 2024 | VariSoft Infusion Set, Single Use. | Unomedical A/S | Device | Class II | 1 |
| 23 Jul 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system | GE Healthcare | Device | Class II | 1 |
| 22 Jul 2024 | Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00 | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 4 |
| 19 Jul 2024 | Supreme Peppers Tri Blend 8-50053-68534 8 OZ Supreme Jalapenos Diced 8-50053-68536 7 OZ Supreme Peppers W/Onions 8-50053-68538 7 OZ Supreme Peppers Snacking 8-50053-68553 12 OZ | GBC Food Services, LLC dba Yummi Sushi | Food | Class I | 3 |
| 19 Jul 2024 | Pita Jungle Greek Salad packaged in 11.8oz plastic clamshell container. | SSP America PHX, LLC | Food | Class II | 6 |
| 19 Jul 2024 | Butternut Squash Cubes - 12oz Plastic Clam-Shell Container | JFE FRANCHISING INC | Food | Class I | 6 |
| 18 Jul 2024 | Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail | Boston Scientific Corporation | Device | Class II | 5 |
| 17 Jul 2024 | Power Express, REF B90918 | Beckman Coulter Biomedical GmbH | Device | Class II | 3 |
| 17 Jul 2024 | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | Mazor Robotics Ltd | Device | Class II | 1 |
| 16 Jul 2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B… | Philips Respironics, Inc. | Device | Class I | 3 |
| 12 Jul 2024 | GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available | GE Healthcare (China) Co., Ltd. | Device | Class II | 1 |
| 12 Jul 2024 | Ion Endoluminal System, REF: 380748-65 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 11 Jul 2024 | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM;… | Medtronic Inc. | Device | Class II | 1 |
| 10 Jul 2024 | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 10 Jul 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument | Beckman Coulter, Inc. | Device | Class II | 1 |
| 9 Jul 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | CareFusion 303, Inc. | Device | Class II | 2 |
| 9 Jul 2024 | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | Medtronic Perfusion Systems | Device | Class II | 1 |
| 9 Jul 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener | Smith & Nephew, Inc. | Device | Class II | 2 |
| 8 Jul 2024 | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions | Ion Beam Applications S.A. | Device | Class II | 1 |
| 5 Jul 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 4 Jul 2024 | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System Event 95077 | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL | Device | Class II | 1 |
| 1 Jul 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A… | W L Gore & Associates, Inc. | Device | Class II | 2 |
| 1 Jul 2024 | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO | Neurovision Medical Products Inc | Device | Class II | 1 |
| 27 Jun 2024 | Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 17 |
| 25 Jun 2024 | 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF… Event 95133 | UNIMAX MEDICAL SYSTEMS INC | Device | Class II | 1 |
| 18 Jun 2024 | CRANIOTOMY PACK, Pack Number DYNJ46552O | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 4 |
| 17 Jun 2024 | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. Event 94910 | Abbott Diagnostics Technologies AS | Device | Class II | 1 |
| 17 Jun 2024 | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator. Event 95131 | Name withheld | Device | Class II | 1 |
| 11 Jun 2024 | Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/case), and 6860 (8… | Medical Action Industries, Inc. 306 | Device | Class II | 1 |
| 7 Jun 2024 | smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN,… | Smiths Medical ASD Inc. | Device | Class I | 3 |
| 2 Jun 2024 | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. Event 94977 | Treace Medical Concepts, Inc. | Device | Class II | 1 |
| 31 May 2024 | Pneupac paraPAC plus 300 ventilator kit, REF P300NXX | Smiths Medical ASD Inc. | Device | Class I | 2 |
| 29 May 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180 | Smiths Medical ASD Inc. | Device | Class I | 28 |
| 28 May 2024 | Spice Class brand Ground Cinnamon packed in 7oz and 11oz PET jars Event 95061 | American Spice LLC | Food | Class II | 1 |
| 27 May 2024 | Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and… | Hitachi America, Ltd., Particle Therapy Division | Device | Class II | 3 |
| 22 May 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 9 May 2024 | Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No.… | Sol-Millennium Medical Inc. | Device | Class II | 6 |
| 8 May 2024 | Marabou Sea Salt Chocolate Bar; 185g; yellow plastic packaging and the word 'havvsalt', the Swedish word for "sea salt"; product is a flat chocolate bar Event 95091 | BonBon NYC LLC. | Food | Class I | 1 |
| 7 May 2024 | Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 4 |
| 8 Apr 2024 | Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 8 |
| 8 Apr 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 13 |
| 8 Apr 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 7 |
| 8 Apr 2024 | Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 27 |
| 8 Apr 2024 | Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 81 |
| 5 Mar 2024 | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 1 Mar 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L | Olympus Corporation of the Americas | Device | Class II | 2 |
| 1 Mar 2024 | 25-LHP-828, HeNe Laser System, 35 mW | PACIFIC LASERTECH, LLC | Device | Class II | 3 |
| 4 Jan 2024 | Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 11 Dec 2023 | BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patient’s physiological parameters so that the patient can control voluntarily these physiological parameters. Event 95089 | RONAN MEDICAL LLC | Device | Class II | 1 |