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

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PANOURA 18S

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780798·LEVAMED ACTIVE ANKLE SUP SLVR R I

Vatech Clismile

FDA UDI
Rayence Co., Ltd.·08800018601020·This product is an orthodontic bracket and is u...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450159989·

PAINFUSOR CATHETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN

FDA 510(k)
FDA Class 1 ·General Hospital

CPCI MOTION CONTROL ASSEMBLY 3.0

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 30, 2018

PELVILACE BIOURETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 8, 2013

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 23, 2014

MICRO-V ALTERNANS SENSORS

FDA Adverse Event
Other ·CAMBRIDGE HEART, INC.·Product code DRX·May 26, 2011

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

FDA Enforcement
Class II ·Terminated·Medrad Inc·February 27, 2013