24 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTIBOND SOLO PLUS 4
FDA 510(k)
FDA Class 2
·Dental
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00140271·
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554265·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554272·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554296·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554258·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554289·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140200·T-Handle, T30 Split Tip Cap Starter
MAXIM KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER REMOTE SURGICAL PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 6, 2019
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·May 9, 2025
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD·Product code MMI·March 14, 2008