19 results · 18ms · 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.

AURA TEK FDP

FDA 510(k)
FDA Class 2 ·Immunology

artegral

FDA UDI
Merz Dental GmbH·D7091970353·anteriors; shade C4; mould BM

KELSEY INTERSITITAL LASER THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)
FDA Class 2 ·Hematology

ARTICULEZE M HEAD 36MM -2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·February 20, 2013

NEW LIGASURE 5MM

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·January 18, 2011

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 31, 2014

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022

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