23 results · 23ms · Sources: EU EUDAMED, US FDA

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Materialise Glenoid Positioning System

FDA 510(k)
FDA Class 2 ·Orthopedic

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...

Sierra Summit/Ascent

FDA UDI
CADWELL INDUSTRIES, INC.·00840067100356·Sierra Summit Footswitch

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319721230·Buck Ear Curette 6-1/2" (16.3cm), size 5, blunt...

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

GN OTOMETRICS TYPE 1053 FREEFIT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·September 14, 2024

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·October 6, 2008

ILAB ULTRASOUND IMAGING SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·June 26, 2013

INRATIO

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 19, 2011

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025

POLYETHYLENE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQO·April 5, 2022

CONTOUR® PLUS

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