12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFECARE® THC Urine Strip Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Oticon
FDA UDI
Oticon A/S·05707131339744·SIYA 1, KIT 312 NFM 85 PB L C001
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
VPS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
FINESSE PERSONAL INSULIN DELIVERY PATCH
FDA 510(k)
FDA Class 2
·General Hospital
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
APEX MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·October 1, 2008
REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 27, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 22, 2011
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