14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM Vida, MAGNETOM Sola
FDA 510(k)
FDA Class 2
·Radiology
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
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365117268·
Bioseal Inc.
FDA UDI
BIOSEAL·00630094022048·Packing Gauze X-Ray Detectable
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530330·RZ Tebbet Breast Retractor
220x25...
Female Luer Lock Cap
FDA 510(k)
FDA Class 2
·General Hospital
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 10, 2017
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code MGB·August 23, 2011
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 4, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025