27 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BI-3M NEEDLE-FREE INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040047866·Scaler Crane Kaplan DE #6
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468432·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468418·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468449·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468401·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468395·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468425·
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
FDA 510(k)
FDA Class 2
·Ophthalmic
PCCR DIGITAL IMAGING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2025
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 20, 2013
CRYOVALVE SG
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·March 10, 2011
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2008
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code NJE·November 5, 2015
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code NJE·November 5, 2015
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code NJE·November 5, 2015
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code NJE·November 5, 2015