22 results
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32ms
·
Sources: EU EUDAMED, US FDA
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450462683·
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 4, 2025
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481684·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481707·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132120·Trial, TLIF, 27L OB CRV 7Deg, 12mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481660·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481691·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033482094·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481714·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481677·
MODIFICATION TO THE BOLD SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
FDA 510(k)
FDA Class 2
·General Hospital
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE 7 CO. KG·Product code DTB·November 4, 2009
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 7, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 20, 2013
CRYOVALVE PULMONARY VALVE & CONDUIT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·March 10, 2011
G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 14, 2008
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022