74 results · 20ms · Sources: EU EUDAMED, US FDA

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AccuPoint Electrode

FDA 510(k)
FDA Class 2 ·Neurology

ORIGEN DBM WITH BIOACTIVE GLASS

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

FDA 510(k)
FDA Unclassified ·Unknown

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973257·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973301·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970041·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970065·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970058·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970805·

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025