9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FitRelief TENS&EMS Wireless Device
FDA 510(k)
FDA Class 2
·Physical Medicine
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994455734·CASE 6191938 ATL TRANS LNG PLT CADDY
Oticon
FDA UDI
Oticon A/S·05707131340351·SIYA 2, KIT 10 NFM 85 C001
MEDILAS H RFID LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·August 4, 2011
ACCENT DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026