8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS(R) THREADED HA ACETABULAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
ABL80 SC80
FDA UDI
Radiometer Medical ApS·05700699456915·SC80 100/30 BG/Hct, no QC3
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
FOCUS RTP
FDA 510(k)
FDA Class 2
·Radiology
PFC MOD PL TB WDG STP-10MM SZ5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 30, 2010
ACTIVA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code MHY·February 6, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024