15 results · 30ms · 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.

Lacriflow CL

FDA 510(k)
FDA Unclassified ·Unknown

GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

DETAX IMPLANTLINK SEMI

FDA 510(k)
FDA Class 2 ·Dental

RIVA STAR SILVER DIAMINE FLUORIDE

FDA Adverse Event
Injury ·SDI LIMITED·Product code LBH·February 13, 2019

TRULIANT TIB IMP CRC INSERT SZ 4, 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 30, 2022

HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·January 9, 2009

SYNCHROMED EL

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 14, 2013

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011

3.5MM CORTEX SCREW SELF-TAPPING

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·September 18, 2008

TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 23, 2024

TRULIANT PS CEM FEM PS CEM LEFT SZ 4

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 19, 2022

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

FDA Enforcement
Class II ·Terminated·Anjon Holdings·August 19, 2020

ADVANCED PATELLA 29M 3 PEG IMPLANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

TRULIANT PS CEM FEM PS CEM RIGHT SZ 4

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 19, 2022

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024