23 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010091024·9 MM CANNULATED DRILL BIT
Smith and Nephew
FDA UDI
Provision·B504OM0135450·
Smith and Nephew
FDA UDI
Provision·00810041631558·
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 5, 2026
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 5, 2026
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 5, 2026
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512463·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012740·PedFuse Remind LES, Quad-H, 5.0mm x 45mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512432·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512449·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512425·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512470·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512456·
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
TBW
FDA 510(k)
FDA Class 2
·Orthopedic
FETAL MONITOR/CARDIOTOCOGRAM
FDA Adverse Event
Injury
·BISTOS CO., LTD.·Product code HGL·January 29, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 20, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 3, 2011
CONCERTO CRT-D DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·March 10, 2008