14 results · 20ms · 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.

BIO-MODULAR SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155992·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 230mm

QUIK-DOT C REACTIVE PROTEIN

FDA 510(k)
FDA Class 2 ·Immunology

3M Clarity Aligners

FDA 510(k)
FDA Class 2 ·Dental

PREMIER ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 7, 2013

CONSULTA

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011

ENPULSE DR

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·August 8, 2014

GORE® DUALMESH® BIOMATERIAL

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020

GORE® DUALMESH® BIOMATERIAL

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

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