12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHEPARD INTRAUTERINE INSEMINATION CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022469·PEERLESS 0DEG SGL FM 0TRQX022 LL/UR
FORZA
FDA UDI
Orthofix US LLC·18257200077359·FLAT RASP
BINAXNOW PBP2A TEST, MODEL 890-000
FDA 510(k)
FDA Class 2
·Microbiology
HEARING AID, OTICON I II H
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GIALLOY CB/N-H
FDA UDI
SRL Dental GmbH·ESRL58903011·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...
PYRAMESH® IMPLANT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014
DELTAPLUSH - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·December 29, 2012
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·October 22, 2010
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
PYRAMESH IMPLANT SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024