13 results
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21ms
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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
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514308·
3B WILLOW
FDA 510(k)
FDA Class 2
·Anesthesiology
ACUTEVENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·July 9, 2013
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021