27 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
FDA 510(k)
FDA Class 2
·Neurology
Tandem Mobi Autosoft XC Kit
FDA UDI
Tandem Diabetes Care, Inc.·00389152312071·Autosoft XC 23"/6mm 10 pack
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033465073·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033465066·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033465097·
CorticaLINK
FDA UDI
LINKSPINE, INC.·00817329022510·Ti Rod - Curved - 120mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033465080·
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130201·PLATE CALIPER
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece
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
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
THERMACHOICE CATHETER UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code MNB·November 29, 2018
CM ALVIM IMPLANT 3.5X13 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018
THERMACHOICE CATHETER UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code MNB·December 5, 2018
THERMACHOICE CATHETER UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code MNB·December 4, 2018
ACRYSOF
FDA Adverse Event
Injury
·ALCON MANUFACTURING, LTD.·Product code HQL·June 12, 2013
ASR 300 SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
BOOMERANG CATALYST SYSTEM
FDA Adverse Event
Injury
·CARDIVA MEDICAL, INC.·Product code MGB·March 14, 2008