14 results · 21ms · Sources: EU EUDAMED, US FDA

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UNIVERSAL VIAL ACCESS SPIKE

FDA 510(k)
FDA Class 2 ·General Hospital

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014608785·MIDMARK 4" SOFTCARE

SPERM WASH MEDIUM, CAT# 2003/2005

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131

FDA 510(k)
FDA Class 2 ·Orthopedic

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

XMAX MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 24, 2013

VASOVIEW HEMOPRO 2 EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·April 13, 2011

REVERSE SHOULDER SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·July 23, 2008

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008

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

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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