21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SteriCUBE® Multiple Tray Sterilization Systems
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578648·CoRoent Ant TLIF Ti, 12x12x32mm 8°
Philips
FDA UDI
Sbo Hearing A/S·05714464011087·HEARLINK 5030 MNR T R TP
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705022434·HEALIX ADVANCE Full Tap Package Contains: 1 Ful...
EMS PIEZON MASTER 600
FDA 510(k)
FDA Class 2
·Dental
CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·June 18, 2019
8MM X 30MM BIOCRYL RAPIDE INTERFERENCE SCREW
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·November 4, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
SUMMIT DUOFIX TAP SZ5 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 12, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 8, 2021
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·August 20, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·August 20, 2025
CD HORIZON® BALLAST¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·February 6, 2024
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 24, 2022
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 24, 2022
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 17, 2023
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013