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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Sugita AVM Microclip Applier
FDA 510(k)
FDA Class 2
·Neurology
TASMIN R 22°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844015148·The basic shape of the TASMIN R devices is a ho...
N/A
FDA UDI
PENTAX OF AMERICA, INC.·04961333242672·24 SDI TO SDI CABLE
INSIGNIA
FDA 510(k)
FDA Class 2
·Dental
LIGHT CURE DENTAL DAM
FDA 510(k)
FDA Class 1
·Dental
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GEI·November 5, 2008
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 24, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 3, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024