72 results · 24ms · Sources: EU EUDAMED, US FDA

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LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

FDA 510(k)
FDA Class 1 ·Microbiology

BI-METRIC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304254657·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970560·

DMS 300-2, 300-3 AND 300-4

FDA 510(k)
FDA Class 2 ·Cardiovascular

PROLYTE ELECTROLYTE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973479·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970881·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973080·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973707·

PROTECTA XT CRT-D

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

LOCKING TITANIUM ADAPTER

FDA Adverse Event
Malfunction ·KANAE CO.,LTD.·Product code KDJ·June 11, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 15, 2011

UNITIP CATHETER FOR HR GI

FDA Adverse Event
Injury ·UNISENSOR AG·Product code FFX·August 25, 2014

GRYPHON P BR DS ANCHOR W/ORTHOCORD

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code MAI·September 19, 2022

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