13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ITOTAL IDENTITY TIBIAL CUT GUIDE LARGE LEFT
FDA UDI
Conformis, Inc.·00810933030544·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605197·MAQUET/SIEMENS 1130 4.25" SOFTCARE PLUS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450054697·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450600726·
SELICOR, MODELS A100 & D100
FDA 510(k)
FDA Class 2
·Physical Medicine
UMBICUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORTIFY ST DR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 7, 2011
GLENOSPHERE ORIENTATION GUIDE
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 18, 2008
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2,630. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Injection Media Contrast Kit Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code FMI·September 1, 2009
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