14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex RetroFusion Screw
FDA 510(k)
FDA Class 2
·Orthopedic
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240940·
AGXO
FDA UDI
Oticon A/S·05707131284389·H110V2 TI, BTE 13 WL 85 SIL AGXO
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282917·ISRAEL RETRACTOR 9 1/2" 3 PRONGS
ELMED
FDA UDI
ELMED INCORPORATED·00842180183094·TEBBETS RIBBON RETRACTOR, OVERALL LENGHT 5" (13CM)
INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·December 21, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 8, 2014
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013
VISTA BASIC SAFETY INFUSION SYSTEM
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·June 20, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016