8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156036·K-WIRE - SINGLE TROCAR 0.9mm DIA x 230mm
SLIP JOINT PLIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ELEKTA MICRODRIVE, MODEL 916716
FDA 510(k)
FDA Class 2
·Neurology
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 24, 2014
SIZE 4-8 KEEL PUNCH GUIDE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 7, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 4, 2013
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025