11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire
FDA UDI
Promepla·03700512967682·
GLOBAL BY <GENX> BLASTOCYST MEDIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK, PIPERACILLIN, 100MCG
FDA 510(k)
FDA Class 2
·Microbiology
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
GENESYS HTA PROCERVA®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·May 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011
PINN MAR LIP LNR 32IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 30, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
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