159 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vitrea Software Toshiba Package, VSTP-001A
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE
SYNTHOGRAFT
FDA 510(k)
FDA Class 2
·Dental
Z.ONE ULTRA ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
CATALYS SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code OOE·October 30, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·June 30, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 10, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·July 13, 2018
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 28, 2022
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·June 1, 2018
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·June 1, 2018
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·October 3, 2018
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·September 19, 2018