11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699357·Titanium Base Abutment Round, Conical L6mm H2mm...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023454·
Crescendo Meniscal Insert PS 17mm Size 6
FDA UDI
AMPLITUDE SAS·03701089525411·
PRIMAFLOW
FDA 510(k)
FDA Class 2
·Dental
AQUARIUSNET SERVER
FDA 510(k)
FDA Class 2
·Radiology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·April 22, 2013
55MM SELECTABLE NEW TLC
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 28, 2011
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012