15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Zipline Access Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012519·
TROCAR SLEEVE
FDA Adverse Event
Malfunction
·APPLIED MEDICAL DISTRIBUTION·Product code GCJ·June 16, 2016
MESACUP TEST PR-3
FDA 510(k)
FDA Class 2
·Immunology
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
FDA 510(k)
FDA Unclassified
·Unknown
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·November 10, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·September 9, 2011
ARTICULEZE M 28MM 1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 22, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2024
GS CORPATCH
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·October 8, 2025
CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·July 6, 2016
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020