15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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