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

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STRONG Dental Handpieces

FDA 510(k)
FDA Class 1 ·Dental

DESARA MINI

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

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

FAST-FIX 360

FDA Adverse Event
Malfunction ·MANSFIELD MANUFACTURING SITE·Product code GAT·June 3, 2013

530 G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 29, 2011

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

TI LOW PROFILE SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 20, 2019

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Injury ·COOK INC·Product code EZN·May 21, 2019

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017