20 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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