375 results · 25ms · Sources: EU EUDAMED, US FDA

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SEJONG Surgical Gown Soft

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

WOUND PROTECTOR/RETRACTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR

FDA 510(k)
FDA Class 2 ·General Hospital

INTERSTIM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 31, 2008

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 23, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

3T HEATER/COOLER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026

HEATER-COOLER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025

HEATER-COOLER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUSTCHLAND·Product code DWC·April 7, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·March 26, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·February 10, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 20, 2026

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 23, 2026

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025