21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE SURGICAL STAPLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496013860·MARILYN 70 SHEER, SIZE S, BLU SCURO, GRADUATED ...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518250·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518212·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361013075·PedFuse Remind LES, Quad-H, 7.0mm x 60mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518236·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518243·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518199·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518229·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518205·
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
FDA 510(k)
FDA Class 1
·General Hospital
KEYST0NE MEDICAL PICC CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·March 20, 2013
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
DXTEND MBLOC HUM EPI 1 D10 STD
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code HSD·March 14, 2008
REDUCED SIZE SCREW EXPANDABLE LEFT DISTAL FEMORAL 20CM REPLACEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 26, 2021
SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022