20 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpermAlign Sperm Separation Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Laser Therapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMI REPROCESSED MULTIPLE CLIP APPLIERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 25, 2011
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 18, 2013
M/H 3HOLE RLC SHL NRS 58MM/L25
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code LPH·August 8, 2018
ML-HD MOD CALC PROX 34B
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code LPH·August 8, 2018
COCR TROCH CABLE 2.0MMX750MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR TROCH CABLE 2.0MMX750MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR CABLE SLEEVE 2.0MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR CABLE SLEEVE 2.0MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR TROCH CABLE 2.0MMX750MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR TROCH CABLE 2.0MMX750MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
COCR CABLE SLEEVE 2.0MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
ARCOMXL 36MM RLC LNR HW SZ25
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code LPH·August 8, 2018
COCR CABLE SLEEVE 2.0MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDQ·September 18, 2018
36MM COCR MOD HD STD
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDI·August 8, 2018
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025