10 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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R2 Studio Q/RCT820
FDA 510(k)
FDA Class 2
·Radiology
HEALIX PEEK ORTHOCORD
FDA UDI
Medos International Sàrl·10886705007677·HEALIX PEEK 3 - Suture Anchor w/ORTHOCORD PEEK ...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134859·LATERAL,NERVE RETRACTOR
EXOMIO, MODEL 1.1
FDA 510(k)
FDA Class 2
·Radiology
THEYFIT MALE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXPANDING HUMERAL INSERT TRIAL - SMALL 40MM CONSTRAINED
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWS·November 3, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 12, 2013
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·July 30, 2018
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024