25 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ecosite Bulk Fill
FDA 510(k)
FDA Class 2
·Dental
Sklar®
FDA UDI
SKLAR CORPORATION·10649111214196·MIXTER FCP RT ANG 7 1/4"
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018647·Obturator 2.0 x 110mm blunt tip
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376271118·MIS Vertical Compressor/Distractor, Center Handle
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
TSRH(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022
SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·October 15, 2014
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·Product code ITX·May 25, 2021
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 16, 2024
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 2, 2024
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code ITX·September 5, 2018
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code ITX·October 31, 2023
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·April 17, 2018