8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nio Color 3MP (MDNC-3421)
FDA 510(k)
FDA Class 2
·Radiology
PACENTRIC CONNECT, TRAVELER AND WEB
FDA 510(k)
FDA Class 2
·Radiology
REVISION PROTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 23, 2013
CODEMASTER XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code LDD·June 22, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEATHCARE CORPORATION·Product code KDI·October 14, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024