12 results
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32ms
·
Sources: EU EUDAMED, US FDA
HEDLEYL INTRAMEDULLARY PREPARATION BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515241923·Cottle Spec, 90mm blds, 10mm to 8mm taper
SUPERNOVA C5 MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
FDA 510(k)
FDA Class 1
·Microbiology
SET, ADMINISTRATION, INTRAVASCULAR, PRODUCT CODE: FPA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·April 22, 2020
SET, ADMINISTRATION, INTRAVASCULAR, PRODUCT CODE: FPA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·April 22, 2020
SET, ADMINISTRATION, INTRAVASCULAR, PRODUCT CODE: FPA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·April 22, 2020
CADD EXTENSION SET
FDA Adverse Event
Malfunction
·Product code FPA·April 21, 2020
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 15, 2014
DEPUY PRODIGY HIP STEM W/POROCOAT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 28, 2013
PUMP MMT-515NAP PRDGM INS V 2.1 PL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·December 7, 2010
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