18 results · 35ms · Sources: EU EUDAMED, US FDA

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Shoulder Innovations Total Shoulder System

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROPLEX COIL SYSTEM- COSMOS

FDA 510(k)
FDA Class 2 ·Cardiovascular

INREACH SYSTEM, MODEL AAS00161-02

FDA 510(k)
FDA Class 2 ·Radiology

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

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

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

GORILLA/BABY GORILLA PLATING SYSTEM

FDA Adverse Event
Injury ·PARAGON 28, INC·Product code HRS·September 17, 2020

ACCU-CHEK ® AVIVA COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 22, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

OT DELICA LANCING DEVICE

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

INTELLAMAP ORION?

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

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 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

INTELLAMAP ORION

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

PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018