14 results
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18ms
·
Sources: EU EUDAMED, US FDA
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517378415·CoRoent® LO, 11x10x35mm 5°
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282962·LANGENBECK RETRACTOR 5/8"x1 1/2"
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746190179·DB BKT SL EMPOWER PASSIVE UR CEN 022 T+12 A+5 R=0
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746189951·DB BKT SL EMPOWER INTERACT UR CEN 022 T+12 A+5 R=0
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746009648·DB BKT SL EMPOWER INTERACT UR CEN 022 T+12 A+5 R=0
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746012273·DB BKT SL EMPOWER PASSIVE UR CEN 022 T+12 A+5 R=0
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WHITTLESTONE EXPRESSER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 22, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·November 29, 2012
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·September 30, 2010
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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