11 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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VASOBand Vascular Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812415·Ballenger Swivel Knife Blade, Straight, 4mm, 19...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721308·Billeau Flexible Ear Loop 6-1/2" (16.3cm), larg...
ROM + COMPLETE KIT
FDA Adverse Event
Malfunction
·CLINICAL INNOVATIONS, LLC·Product code NQM·July 15, 2019
CARESTREAM DRX-1 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EXCELLAGEN
FDA 510(k)
FDA Unclassified
·Unknown
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 26, 2013
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·October 6, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022