13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIRSONETT AIR-4
FDA 510(k)
FDA Class 2
·General Hospital
GYRUS ACMI
FDA UDI
Gyrus ACMI, LLC·00821925033313·EAR SPECULUM ADULT, 6 MM DISPOSABLE
Instruments for Revision Surgery
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033539·Bone Cement Gouge, Stainless Steel, Version= st...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857560833·Forward Angled Curette Size #2
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
FDA 510(k)
FDA Class 2
·Immunology
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FORCEPS CEV134 BIPOLAR 350MM MOUIEL [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 5, 2014
FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·May 24, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 30, 2014
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 30, 2018
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019