22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
FDA 510(k)
FDA Class 2
·Radiology
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAPERED SCREW-VENT T IMPLANT
FDA 510(k)
FDA Class 2
·Dental
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 12, 2024
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 28, 2024
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026
IMP,TSV,6.0,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 15, 2025
IMP,TSV,3.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·October 7, 2015
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 6, 2024
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 8, 2024
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 4, 2023
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 27, 2021