8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uMR Jupiter
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776299989·Dyonics Style 4.5mm Operative Cannula
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
FDA 510(k)
FDA Class 2
·Microbiology
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025