24 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORBIT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450535745·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412572·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197046541·DeBakey Diethrich Forceps
1,5mm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197046534·DeBakey Diethrich Forceps
1,5mm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197046558·DeBakey Diethrich Forceps
1,5mm ...
ZEISS INFRARED 800 WITH FLOW 800 OPTION
FDA 510(k)
FDA Class 2
·Radiology
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
FDA 510(k)
FDA Class 2
·Neurology
BD BBL¿ PLATE TSA5% SB//LEVINE EMB
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·September 15, 2022
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 24, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·August 20, 2008
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
BD PHOENIX PMIC110
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025