16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
APTUS Clavicle System
FDA 510(k)
FDA Class 2
·Orthopedic
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AURA
FDA 510(k)
FDA Class 2
·Dental
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
HELICAL BLADE EXTRACTOR
FDA Adverse Event
Malfunction
·Product code LXH·February 4, 2016
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
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
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023
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