18 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.

Disposable High Pressure Injector Syringe

FDA 510(k)
FDA Class 2 ·Cardiovascular

Column, Ascarite, Desiccator, Disposable

FDA UDI
A-M SYSTEMS, LLC·00817081026078·Column, Ascarite, Desiccator, Disposable

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

BD NANO¿ ULTRA FINE¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 17, 2023

BD NANO¿ ULTRA FINE¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 17, 2023

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

ECHELON 45 ENDOPATH

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 17, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

ELAN 4 MIS SLEEVE F/1-RING HANDPIECES

FDA Adverse Event
Injury ·AESCULAP AG·Product code HBC·October 28, 2018

ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code HBC·November 5, 2018

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

Allegiance Esmark 6' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-063A

FDA Recall
Terminated ·International Medsurg Connection, Inc.·Product code MHW·August 16, 2006

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