49 results · 24ms · 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.

CHARTIS CATHETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

MOLINA ORBITAL MALAR DISTRACTOR

FDA 510(k)
FDA Class 2 ·Dental

HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO

FDA 510(k)
FDA Class 2 ·General Hospital

OPTETRAK

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 2, 2022

LOGIC TIBIA PS MOD INSRT SZ 3 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 2, 2022

FREESTYLE AORTIC ROOT BIOPROSTHESIS

FDA Adverse Event
Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

LOGIC TIBIA PS MOD INSRT SZ 5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 23, 2022

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

FORTIFY DR, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 11, 2011

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·July 25, 2008

OPTETRAK

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 4, 2022

LOGIC TIBIA PS MOD INSRT SZ 4 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 3, 2024

LOGIC TIBIA PS MOD INSRT SZ 5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 10, 2023

LOGIC TIBIA PS MOD INSRT SZ 5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 10, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 11, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 11, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 9, 2024

LOGIC FEMORAL PS CEM RIGHT SZ 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 21, 2024

OPTETRAK LOGIC PATELLA COMPONENT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 6, 2025