34 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008928·Zirlux 16+ 0M2 89x17x22
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358290·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358269·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358276·
SPARE PAIR
FDA UDI
FGX INTERNATIONAL INC.·00887661716699·
SPARE PAIR
FDA UDI
FGX INTERNATIONAL INC.·00887661716675·
SPARE PAIR
FDA UDI
FGX INTERNATIONAL INC.·00887661716682·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358252·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358245·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033358283·
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
FDA 510(k)
FDA Class 2
·General Hospital
PROFILE II ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
JTS UNIT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
JTS COIL
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020
JTS DRIVE UNIT SET
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 9, 2011
*
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code BTR·February 20, 2008