74 results · 21ms · Sources: EU EUDAMED, US FDA

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SFI-ANCHOR

FDA 510(k)
FDA Class 2 ·Dental

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101369·Poly Insert PS, Size 6, 18mm

KING SEPTEMS

FDA Adverse Event
Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Orthopedic

WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HTO·May 24, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 30, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

13 CM TRICUT BLADE

FDA Adverse Event
Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

CURVED SINUS BURS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

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