18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TE7/TE5 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
FDA 510(k)
FDA Class 2
·Neurology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154142·Tesera X Angled Trial, 60mm x 22mm x 18mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154111·Tesera X Angled Trial, 60mm x 22mm x 12mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154104·Tesera X Angled Trial, 60mm x 22mm x 10mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154135·Tesera X Angled Trial, 60mm x 22mm x 16mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154128·Tesera X Angled Trial, 60mm x 22mm x 14mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154098·Tesera X Angled Trial, 60mm x 22mm x 8mm x 0°
CRTS SM IL SG UTZ BAC CATH ACC
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·September 6, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013
SYNCHRON LX20 PRO CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011
INTELECT MOBILE 2 CH STIM
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IPF·September 29, 2008
GENTLE CATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code GBM·January 28, 2019
GENTLE CATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code GBM·January 28, 2019
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022