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

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Juliet® Ti

FDA 510(k)
FDA Class 2 ·Orthopedic

Bard® Extension Cord

FDA UDI
C. R. Bard, Inc.·00801741045868·Bard® Extension Cord

Zavation

FDA UDI
Zavation LLC·00842166180659·ALIF Sizer 15deg 36mm x 21mm

ZAVATION

FDA UDI
Zavation LLC·00842166154988·WHITNEY 15deg 36mmx21mm

Zavation

FDA UDI
Zavation LLC·00842166106277·ALIF 15deg 36mmx21

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183555·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

ZAVATION

FDA UDI
Zavation LLC·00842166157200·HA+ ALIF 15deg 36mmx21

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183470·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575268627·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025

SMARTDRIVE WHEELCHAIR POWER-ASSIST

FDA 510(k)
FDA Class 2 ·Physical Medicine

OPTICROSS 40 MHZ CORONARY IMAGING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CODA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQY·January 30, 2019

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2019

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014