13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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