11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MMI/GAELTEC CATHETER TIP TRANSDUC
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001309·VITROS Immunodiagnostic Products PSA Reagent Pack
ACUMED
FDA UDI
Acumed LLC·10806378051425·T6 Stick Fit Driver Tip
OCULAR RESPONSE ANALYZER
FDA 510(k)
FDA Class 2
·Ophthalmic
LUNAR REPORT GENERATOR II
FDA 510(k)
FDA Class 2
·Radiology
8CM ANGLE ATTACHMENT, BLACK, MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 27, 2007
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022