48 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L142070120·14mm H x 20mm W x 70mm L XLIF Trial 12 degree L...
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
FDA 510(k)
FDA Class 2
·Cardiovascular
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
FDA 510(k)
FDA Class 2
·Hematology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
LOCKING SCREW Ø3.5 SELF-TAP L24 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·June 3, 2013
AU2700 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JGS·June 28, 2011
SUPERSHEATH
FDA Adverse Event
Malfunction
·TOGO MEDIKIT CO. LTD.·Product code DRE·December 2, 2016
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·June 2, 2022
SUPERSHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO. LTD.·Product code DRE·August 12, 2018
SUPERSHEATH
FDA Adverse Event
Malfunction
·TOGO MEDIKIT CO. LTD.·Product code DRE·December 11, 2016
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DRE·January 18, 2018
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·March 21, 2023
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code QEW·August 7, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO. LTD.·Product code DRE·April 28, 2020
SUPERSHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO. LTD.·Product code DRE·April 11, 2017
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO. LTD.·Product code DRE·February 11, 2020
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·January 19, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO. LTD.·Product code DRE·December 12, 2019