18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DIP Arthrodesis System
FDA 510(k)
FDA Class 2
·Orthopedic
FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE SECTOR II CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013
SOL SYS 10/13.5 R BOW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
CNS-6201
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORP·Product code MHX·September 10, 2014
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code JDI·October 26, 2012
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 26, 2012
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
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 23, 2022
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 23, 2022
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 23, 2022
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 23, 2022
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
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·October 3, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·August 26, 2016