12 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Glidesheath Slender Tibial Pedal Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111041808·VIRTUS SPLINTER FCP SER STR 6"
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
FDA 510(k)
FDA Class 2
·Cardiovascular
NUPRO MODEL 13016901
FDA 510(k)
FDA Class 2
·Dental
DUETTO MT
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022
NOVA MAX TEST STRIPS
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL·Product code NBW·December 5, 2014
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) NON US
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·October 6, 2008
PROCISE MAX
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·June 25, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016