12 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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