9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
FDA 510(k)
FDA Unclassified
·Unknown
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10889942115372·BONE RECOVERY PACK-LF
COULTER DART ALT (GPT) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TL100W/01 UVB LAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MUSTANG¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·January 15, 2013
SECUR-FIT MAX
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 29, 2010
3.5MM CORTEX SCREW SELF-TAPPING 24MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·July 7, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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