12 results · 19ms · Sources: EU EUDAMED, US FDA

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VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN

FDA 510(k)
FDA Class 2 ·Cardiovascular

Shoreline™ ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981177171·Modular Trial, 16 x 14 x 8mm, 7 Deg Lordosis

DARCO LOCKING BONE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Solution Set with 1.2 Micron Air Eliminating Filter

FDA 510(k)
FDA Class 2 ·General Hospital

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

CLEARLINK CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021

ATTAIN STARFIX

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 10, 2014

SECURA DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·November 8, 2012

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·October 25, 2023

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012