18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ReNew Sterilization Trays(Catalog #3708 and #3709)
FDA 510(k)
FDA Class 2
·General Hospital
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901527452·12 BLADE FINISHING CARBIDE 7274 - 5 PACK
SignatureX Logical (Wingman)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076405·
V-14 CONTROL WIRE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ASSISTO ARM SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
AGC DA2000 KN TIB BRG 71/75X8
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 9, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 8, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 8, 2014
MISEAL DISPOSABLE KIT
FDA Adverse Event
Malfunction
·STARION INSTRUMENTS·Product code GEI·June 24, 2011
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025
TINBN VANGUARD INT PS ANAT FM R 75MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·June 4, 2025
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025
VENATECH CONVERTIBLE
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
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