25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Burn-out Cylinder and Angled Screw Abutments
FDA 510(k)
FDA Class 2
·Dental
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711604831·83mm Cervical Plate, 4 Level
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045621·Unitek(TM) Molar Band General Purpose Wide Regu...
MODIFIED HD GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 10, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 1, 2011
REMANUFACTURED I-PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FRN·September 12, 2008
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019