10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909138052·REVELATION DIAMOND 885-012SC-S - 5 PACK
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450595121·
FIXATE TISSUE BAND
FDA 510(k)
FDA Class 2
·Neurology
KOWA AUTOMATED TONOMETER KT-500
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 26, 2010
PRODISC-C REVISIONS
FDA Adverse Event
Injury
·SYNTHES·Product code MJO·January 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
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