11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
FDA 510(k)
FDA Class 2
·Neurology
PicoStar
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stativ® Knotted UHMWPE Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 1.0ML 31GA 6MM 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 15, 2020
BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 6, 2020
REGEN¿ THT® NC: 1.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 1, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·August 24, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 23, 2013
REGEN¿ THT® NC: 1.0ML TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 1, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025