22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
FDA 510(k)
FDA Class 2
·Microbiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890104180·Zirlux 17 Degree Multi-Unit Abutment 2 mmH comp...
Vivid Elegance Bite CLEAR FS
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0104180·50ml x 2
HENKE-SASS WOLF, GMBH.
FDA registration
HENKE-SASS WOLF, GMBH.·36 products·🇩🇪 Germany
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033149461·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033149423·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033149454·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033149430·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033149478·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
GALAXY G3 XSFT HEL 2MM X 8CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 1, 2020
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
FDA 510(k)
FDA Class 2
·Dental
PDT DOSECALCULATOR, MODEL 80000
FDA 510(k)
FDA Class 2
·Anesthesiology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
ALTRX +4 10D 40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 19, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DRY·March 2, 2011
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025