9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
FDA 510(k)
FDA Unclassified
·Unknown
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756397094·BREAST PACK
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450226209·
ALANTE, BATTERY OPERATED POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN RIGHT ABG II HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWY·January 7, 2013
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 30, 2010
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·July 2, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025