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

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Hi-Torque Command 18 Guide Wire

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

CoRoent

FDA UDI
Nuvasive, Inc.·00887517575463·CoRoent Ant TLIF Ti, 15x12x40mm 4°

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

DENALI DEFORMITY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

FDA 510(k)
FDA Class 2 ·Dental

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2020

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·June 7, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011

GE OEC STENOSCOPE

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 12, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 27, 2016

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024