28 results · 21ms · 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.

VAULT ALIF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776172480·Cushing Dressing Forceps serrated

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169604841·SPACER 2130445 OLIF25 27MM 0 DEG 14X45

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180937·Integra® Jarit® Cushing Dressing Forceps, 7-3/4...

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925018761·MCGEE ROUND PICK, SMALL

POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM

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

KLASSIC HD HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SET, ADMINISTRATION, INTRAVASCULAR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

FLEXCATH STEERABLE SHEATH

FDA Adverse Event
Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·June 16, 2011

GORE VIABAHN ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code NIP·August 19, 2008

LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

STOPCOCK MANIFOLD GANGS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·October 30, 2017

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 9, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·February 28, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 8, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·April 25, 2018

MBB Tray Catalog Number: 9882

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

FDA Enforcement
Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013