23 results · 23ms · 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.

ALEUTIAN IBF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL COMPANY·Product code MTA·June 16, 2011

HAND PIECE FOR BATTERY POWERED DRIVER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HXX·May 29, 2013

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·August 24, 2016

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 4, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 15, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 7, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·May 15, 2019

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·August 18, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 4, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 5, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·April 11, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·April 2, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·March 30, 2018

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·October 3, 2016

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HRS·August 26, 2016

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022