10 results · 20ms · Sources: EU EUDAMED, US FDA

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CAMBRIA

FDA 510(k)
FDA Class 2 ·Orthopedic

RIWO SYSTEM TRAYS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STRYKER POWERED WHEELED STRETCHER

FDA 510(k)
FDA Class 2 ·Physical Medicine

QUADRA H FEMORAL STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 7, 2013

RESTORE SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 29, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 9, 2011

HANDSWITCHING ROCKER SWITCH PENCIL

FDA Adverse Event
Injury ·COVIDIEN VALLEYLAB·Product code GEI·July 3, 2008

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018