13 results · 35ms · Sources: EU EUDAMED, 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