27 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Tandem Mobi Autosoft XC Kit
FDA UDI
Tandem Diabetes Care, Inc.·00389152311975·Autosoft XC, 5"/6mm, 2 pack kit
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756248686·SRHS CARDIAC CATH TRAY
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 2, 2025
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457948·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457924·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457931·
Cosmolock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457917·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457900·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033457894·
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
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 29, 2025
BRACHYSEED PD-103 MODELS #PD1
FDA 510(k)
FDA Class 2
·Radiology
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIAC CATHETER TRAY
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code OEQ·June 1, 2018
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·January 24, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 15, 2013