22 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300031·Mand. 1. Molar band W-Fit right 03
Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)
FDA UDI
VASOMEDICAL, INC.·00817980020825·Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 ...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331115530·Endo Clinch Grasping Forceps - Single Curved, 5...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482130629·Symmetry® Dissector, Endofacial, Curved, 10 1/2 in
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300030101·Mand. 1. Molar band W-Fit right 03
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300030501·Mand. 1. Molar band W-Fit right 03
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300030051·Mand. 1. Molar band W-Fit right 03
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
FDA 510(k)
FDA Class 2
·Radiology
FUSION OMNI-TOME SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 19, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 25, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 11, 2014
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
FDA Recall
Terminated
·Elekta, Inc.·Product code MUJ·September 29, 2016
Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·December 1, 2008
XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·May 27, 2010
XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·September 17, 2010
Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·January 19, 2009
XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·June 9, 2011
XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·October 3, 2010