8 results
·
37ms
·
Sources: EU EUDAMED, US FDA
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
AERODR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CLEARVIEW EXACT II INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code DRA·June 30, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 8, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·November 11, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025