22 results · 32ms · Sources: EU EUDAMED, US FDA

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ECLIPSE TREATMENT PLANNING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

THREADED ROD

FDA UDI
Biomet Orthopedics, LLC·00887868005831·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0430200·Sagittal Bender, Double Ended Left

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0130201·PLATE CALIPER

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE

FDA 510(k)
FDA Class 2 ·Radiology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·September 9, 2014

TRANSPORT SERIES

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2022

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

REF H10

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016