24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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