13 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Intravascular Extension Set

FDA 510(k)
FDA Class 2 ·General Hospital

Kompressor™ Compression Screw System

FDA UDI
Ascension Orthopedics, Inc.·10381780065661·The standard Kompressor Compression Screw is a ...

Onli

FDA UDI
HOLLISTER INCORPORATED·00610075056248·Ready to Use Hydrophilic Intermittent Catheter,...

Accufit

FDA UDI
Ortho Organizers, Inc.·00190707185350·AccuFit™ Molar Band UL7 - 43

MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P

FDA 510(k)
FDA Class 2 ·Cardiovascular

DOLPHIN IMAGING

FDA 510(k)
FDA Class 2 ·Radiology

TALENT AAA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·October 29, 2014

EON 16-CHANNEL IPG

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011

CURRENT RF VR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number: 7210430

FDA Recall
Terminated ·Smith & Nephew, Inc., Endoscopy Div.·Product code LXH·July 1, 2005

PRESIDIO 10 CERE 5MMX17CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·December 29, 2020

PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·April 10, 2017

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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