8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
AUGROS HYSTEROMETER
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SMARTXIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMSYS LNR AOX N 48X36
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 30, 2025
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 23, 2014
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code GEX·November 6, 2012
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015