13 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ARROW GPSCATH BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776172442·MAYO TISSUE FORCEPS

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180890·Integra® Jarit® Mayo Russian Tissue Forceps, 9"...

ArgenZ HT+ 98x25 ML C1B

FDA UDI
ARGEN CORPORATION, THE·D818130397·Dental porcelain/ceramic restoration kit

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

FDA 510(k)
FDA Class 2 ·Immunology

BD PHASEAL PROTECTOR P50J

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

COMP LK SCR 3.5HEX 4.75X25 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

CORE UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 24, 2013

SIMPLEX P-JAPANESE TWIN PACK

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·September 30, 2014

SELECTION

FDA Adverse Event
Malfunction ·MEDTRONIC S.A.·Product code NVZ·June 16, 2011

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012