122 results
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35ms
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Sources: EU EUDAMED, US FDA
CRONO F
FDA 510(k)
FDA Class 2
·General Hospital
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522640·Cannulated Canc Screw, FT, 7.0x85mm
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 85mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010282·
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291102366·SS Suture, 4 per sleeve
Micro-Access Tearaway Introducer Kit
FDA UDI
GALT MEDICAL CORP.·00841268109247·Micro-Access Tearaway Introducer Kit
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 10, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
SOMNO STAR & SERIES SLEEP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ULTRASOUND SCANNER, TYPE 1101
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 4, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 8, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK USA, INC.·Product code KWP·October 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 9, 2019
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018