29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009000·Zirlux 16+ B2 89x17x22
CORTICAL LOCKING SCREW 3.5mm x 12mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665007565·
Ti-Fix OLIF Spacer
FDA UDI
Tyber Medical, LLC·M695P30121200·Ti-Fix OLIF Spacer 30 x 12 x 12 (mm) x 0 °
CorticaLINK
FDA UDI
LINKSPINE, INC.·00817329022466·CoCr Rod - Curved - 120mm
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIDAS TOXO IGG II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LGD·August 6, 2020
VIDAS TOXO IGG II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LGD·August 14, 2020
ARCHITECT CYCLOSPORINE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MKW·May 25, 2012
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013
ALTRX NEUT 28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 15, 2014
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·March 4, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
TAXUS¿ ELEMENT¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 4, 2012
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 8, 2022
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 16, 2022
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 16, 2022
COMPLETE SE ILIAC
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIO·November 5, 2014
COMPLETE SE ILIAC
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIO·November 5, 2014