31 results · 26ms · 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.

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

ZSFab Cervical Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)

KELO-COTE TOPICAL GEL

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

MODEL OBC-63 BREAST ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·December 16, 2013

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·March 9, 2012

LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·March 17, 2021

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·February 27, 2014

LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.

FDA Recall
Terminated ·Physio Control, Inc.·Product code MKJ·May 27, 2010

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008

ACCU-CHECK SPIRIT COMBO

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·August 5, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·January 13, 2014

WOLVERINE CORONARY CUTTING BALLOON

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NWX·August 11, 2025

MEDTRONIC CRT-D

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NIK·August 21, 2024

MEDTRONIC CRT-D

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code NIK·August 22, 2024

ATTAIN PERFORMA S MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code OJX·November 18, 2024