11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Philips Efficia CMS200 Central Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDTOX BUPRENORPHINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GENERAL PURPOSE PROBE COVER
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code KKX·April 21, 2017
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC TIJUANA·Product code LOX·June 16, 2011
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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