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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Change Healthcare Cardiology Hemodynamics
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2308819·Universal guide tube for MicroDrive, for IMM, F...
ACUSON S2000 AND S3000
FDA 510(k)
FDA Class 2
·Radiology
AVANTA CARPAL FUSION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
SMARTLIFE LARGE ASPTC HOUSING
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·November 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 10, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024