51 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Elecsys FT4 III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
T-STAT 303 ISCHEMIA MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013
ASCENSION PIP
FDA Adverse Event
Injury
·ASCENSION ORTHOPEDICS, INC.·Product code KYJ·July 22, 2011
LAP-BAND ACCESS PORT KIT
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·September 29, 2008
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
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 12, 2008