12 results · 27ms · Sources: EU EUDAMED, US FDA

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TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

Eye Shield

FDA UDI
KATENA PRODUCTS, INC.·00841668111185·PIN HOLE EYE SHIELD WHITE PACK OF 12

CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018

AEQUALIS REVERSED HUMERAL SPACER 36MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·July 31, 2015

LCS COMPLETE M/B PAT CEM STD

FDA Adverse Event
Injury ·9616671 DEPUY (IRELAND)·Product code NJL·February 15, 2013

UNKNOWN DEPUY TIBIAL INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 29, 2014

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025

GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026