12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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