15 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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XVAC
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST Men's Dress
FDA UDI
BSN MEDICAL, INC.·00035664107826·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE LAR...
LuxaPost
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107820·Glass fiber-reinforced pre-silanized composite ...
ADVIA Centaur® TSTO
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177519·Testosterone - CENTAUR - RGT - 50 tests
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818301·AXS Add-on Rail Clamp
TRANSAMERICAN TENS
FDA 510(k)
FDA Class 2
·Neurology
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
FDA 510(k)
FDA Class 1
·Ophthalmic
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012