22 results · 25ms · Sources: EU EUDAMED, 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