FDA Medical Devices

NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and pro…

NeuroSync, Inc.

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Versi…

Encore Medical, LP

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Beckman Coulter, Inc.

Critical Jul 23, 2025

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Baxter Healthcare Corporation

Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.

Beyond Laser Systems, LLC

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Versi…

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Versi…

Ortho-Clinical Diagnostics, Inc.

Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.

Beyond Laser Systems, LLC

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Ast…

Medtronic, Inc.

Critical Jul 23, 2025

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Baxter Healthcare Corporation

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Descript…

Edwards Lifesciences, LLC

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension fo…

Canary Medical, Inc.

Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the pe…

Boston Scientific Corporation

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Ed…

Edwards Lifesciences, LLC

Low Jul 16, 2025

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

STRATASYS LTD

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edw…

Edwards Lifesciences, LLC

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VX…

Boston Scientific Corporation

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized…

Boston Scientific Corporation

VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J …

Boston Scientific Corporation

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Prod…

Given Imaging Ltd.

Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachmen…

Alcon Research LLC

Low Jul 16, 2025

TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

STRATASYS LTD

Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product C…

Baxter Healthcare Corporation

O-arm O2 Imaging System. Mobile X-Ray System.

Medtronic Navigation, Inc.-Boxborough

Philips eL18-4 EMT Transducer.

Philips Ultrasound, Inc

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

Philips C9-5EC Transducer.

Philips Ultrasound, Inc

Change Healthcare Cardiology Hemodynamics Software

CHANGE HEALTHCARE CANADA COMPANY

Critical Jul 9, 2025

Servo-u Ventilator System. Model Number: 6688600.

Maquet Critical Care AB

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-501…

CORIN MEDICAL, LTD.

Philips eL18-4 Transducer.

Philips Ultrasound, Inc

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

C.R. Bard Inc

Critical Jul 9, 2025

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sol…

Philips Respironics, Inc.

Philips C5-2 Transducer.

Philips Ultrasound, Inc

Philips L12-3 Transducer.

Philips Ultrasound, Inc

Philips X6-1 Transducer.

Philips Ultrasound, Inc

The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the m…

HemoCue AB

Philips X8-2t Transducer.

Philips Ultrasound, Inc

Philips V6-2 Transducer.

Philips Ultrasound, Inc

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

Siemens Healthcare Diagnostics, Inc.

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid…

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 …

Ortho-Clinical Diagnostics, Inc.

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

Siemens Healthcare Diagnostics, Inc.

Philips S5-1 Transducer.

Philips Ultrasound, Inc

Philips S7-2 Transducer.

Philips Ultrasound, Inc

Philips 3D9-3v Transducer.

Philips Ultrasound, Inc

Philips X7-2t Transducer.

Philips Ultrasound, Inc

Low Jul 9, 2025

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based…

LUMITHERA INC