15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CURITY BEDSIDE DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Needle Holder
FDA UDI
KOROS U.S.A., INC.·10840199534514·Reverse Action Micro Needle Holder Straight 21c...
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581362100001·A-FIT® 1. MOLAR LWR LFT SZ 21
SMARTDRIVE WHEELCHAIR POWER-ASSIST
FDA 510(k)
FDA Class 2
·Physical Medicine
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
FDA 510(k)
FDA Class 2
·General Hospital
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
GEMINI STONE RETRVL PAIRED WIRE HELICAL BSKT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·August 25, 2010
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019
Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code KNT·June 12, 2024
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 7, 2018
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025