9 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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Gexfix External Fixation
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·June 16, 2011
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018