34 results · 22ms · 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.

Brite Tip Radianz Guiding Sheath

FDA 510(k)
FDA Class 2 ·Cardiovascular

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

KARMAN WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NVN·January 13, 2014

MONARC SLING

FDA Adverse Event
Injury ·AMS·Product code FTL·August 4, 2011

NEUROMODULATION PUMP, UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

ANALYTICAL P MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2009

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Malfunction ·HEARTWARE, INC.·Product code DSQ·June 12, 2023

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·October 27, 2022

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Death ·HEARTWARE, INC.·Product code DSQ·October 31, 2022

SMARTSET GHV GENTAMICIN 40G

FDA Adverse Event
Injury ·DEPUY CMW - 9610921·Product code MBB·November 13, 2024

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·October 31, 2022

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·February 9, 2022

BD DISCARDIT¿ II SYRINGE 20ML

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 8, 2022

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·May 19, 2023