10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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bright CT
FDA 510(k)
FDA Class 2
·Radiology
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·July 9, 2004
EXTERNAL FIXATION SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
FDA 510(k)
FDA Unclassified
·Unknown
INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·July 28, 2021
INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 18, 2021
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
CONSTELLATION WITH LASER
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 26, 2011
SUCTION COAGULATOR
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code GEI·July 2, 2013
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014