12 results
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19ms
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Sources: EU EUDAMED, US FDA
FLEXI-TRAK(TM) ANCHORING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707066170·LIGATURE WIRE 011" reel
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100109·DB BRACKET MASTER SERIES MAND ANTERIOR 018 TQ=0...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746063619·DB BKT MINI MS LOWER ANT 018 T=0 A=0 R=0
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112811·3M™ Victory Series™ Second Molar Bands, 905-128...
CL-OPE CONTACT LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 9, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·November 22, 2010
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 1, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024