17 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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Sterilization Tray
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821609120·
Lip Retractors Large
FDA UDI
PRACTICON, INC.·00723896021750·Plastic lip retractor large
Lip Retractors Small
FDA UDI
PRACTICON, INC.·00723896021675·plastic lip retractor small
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311609120·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321609120·
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020652·Cruciate Retaining Tibial Insert
VIDAS® LYME IGM II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LSR·March 3, 2016
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO: HI-ART SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
POLYFLUX R CAPILLARY DIALYZER
FDA Adverse Event
Other
·GAMBRO DIALYSATOREN GMBH·Product code KDI·July 11, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 16, 2011
SMART RELIEF TENS THERAPY
FDA Adverse Event
Injury
·CHATTEM·Product code NUH·October 11, 2017
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 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