10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Primus Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CVS
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428082904·Grab n' Go First Aid Kit
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042158·39x30mm Trial Rasp 16mm 12 deg
ArchForm Orthodontic Software System
FDA 510(k)
FDA Class 2
·Dental
PUMA-G System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 11, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 12, 2011
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 23, 2013
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 18, 2023
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025