671 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074370804·SMALL LAMINAR HOOK TRIAL
LOJIC+
FDA UDI
SDI LIMITED·09336472001452·LOJIC+ 1SP FAST 50
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529001974·A single-use fiberoptic accessory intended for ...
LOJIC+
FDA UDI
SDI LIMITED·DO3642012022·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165666·DEAVER RETRACTOR GRIP HANDLE
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130344·CR Knee Instrument Case 1, Caddy III
PALM ECG RECORDER, MODEL EP-201/202
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRODOSE CATH, MODELS 90121-201, -202, -203
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Safey Pocket Spirometer
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRAQUIET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
FDA 510(k)
FDA Class 2
·Anesthesiology
BLAKE DRAIN
FDA Adverse Event
Injury
·ETHICON, INC.·Product code KOG·November 12, 2012
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 6, 2020
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 13, 2012
MAXIMO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·April 11, 2012
ENTRUST AT
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code LWS·October 12, 2012
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 13, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
CARESCAPE MONITOR B850
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·July 29, 2011