25 results · 22ms · Sources: EU EUDAMED, US FDA

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Athena Surgical RMUS System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENDOBUTTON

FDA UDI
Smith & Nephew, Inc.·03596010497031·55 MM ENDOBUTTON CL BTB

Dilator, Vascular, Memory 20cm 5.0mm alu-handle

FDA UDI
Geister Medizintechnik GmbH·04057034308554·Dilator, Vascular, Memory 20cm 5...

Salvo® Spine System

FDA UDI
Spine Wave, Inc.·10840642174892·10.5 x 70 mm Bone Screw, Cannulated, 3 mm Pitch

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319706367·Kleinert-Kutz Hook 6-1/4" (15.6cm), large size,...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319744321·Kleinert-Kutz Hook 5" (12.7cm), large size, 7mm...

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP

FDA 510(k)
FDA Class 2 ·Neurology

CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 19, 2024

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 16, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 5, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 2, 2025

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

FDA Adverse Event
Other ·DEXCOM, INC.·Product code MDS·August 2, 2011

MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - B

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code KYB·October 22, 2008

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

INDIGO SYSTEM SEPARATOR 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 29, 2022