7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HBPM/LMWH CONTROL KIT
FDA 510(k)
FDA Class 2
·Hematology
ARIOL HER-2/NEU FISH
FDA 510(k)
FDA Class 2
·Immunology
The MeDioStar NeXT Family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6 SHOOTER MULTI-BAND LIGATOR
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code MND·April 30, 2014
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·December 2, 2010
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 9, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022