15 results · 22ms · Sources: EU EUDAMED, US FDA

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ApneaTrak

FDA 510(k)
FDA Class 2 ·Neurology

FIREBIRD SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AVITA WRIST TYPE BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

LASER HAIR GROWTH CAP

FDA Adverse Event
Injury ·UNKNOWN·Product code OAP·February 26, 2025

PENUMA IMPLANT

FDA Adverse Event
Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

EARLYVUE VS30 VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

EARLYVUE VS30 VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

EARLYVUE VS30 VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·June 27, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011

SMALL BATTERY DRIVE

FDA Adverse Event
Malfunction ·SYNTHES OBERDORF·Product code HWE·October 22, 2014

EARLYVUE VS30 VITALS MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

EARLYVUE VS30 VITALS MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

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

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