10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX TI 3 SUTURE ANCHOR w/DYNACORD
FDA UDI
Medos International Sàrl·10886705029952·HEALIX TI 3 SUTURE ANCHOR w/DYNACORD Titanium A...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
Kinepict Medical Imaging Tool 4.0
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 6, 2008
LITHOTRIPSY
FDA Adverse Event
Malfunction
·NA·Product code LNS·August 18, 2011
MEDTRONIC ACTIVA DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC·Product code MHY·July 2, 2013
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
cobas 6000 analyzer series Operators Manual Roche cobas; 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