10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665584175·MIS Fenestrated Screw, Ø4.5 x 30mm, Ø5.5mm Rod
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837017217·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869657457·MOSS XT Ti Pedicle Screw Ø4.5x30mm mintgreen, c...
ICAN GT DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
FDA 510(k)
FDA Class 3
·Cardiovascular
PINN CAN BONE SCREW 6.5MMX30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NDJ·January 22, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·December 14, 2010
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 10, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022