16 results · 20ms · Sources: EU EUDAMED, US FDA

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CONDUCTOR CORONARY GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189428·Apex Revision Knee System - Revision Tibia Ream...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776363420·Cotton Pliers #5

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036027650·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450029305·

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189411·Apex Revision Knee System - Revision Tibia Ream...

OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

FDA 510(k)
FDA Class 2 ·Hematology

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

UNKNOWN LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

HEART START MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 15, 2014

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Injury ·AGA MEDICAL CORPORATION·Product code MLV·May 16, 2011

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

FDA Enforcement
Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020