13 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Normandy VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
Edge™ Diamond PMI012-4M Pear Minimally Invasive
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002769·Diamond dental bur, reusable
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331185298·Rhoton Bipolar Bayonet Forceps, round handle, 1...
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032672·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082007731·
PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 3
·Orthopedic
OPTIBOND XTR
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·September 18, 2014
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2015
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·September 26, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018