24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EUROTROL HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664214678·ULTRA SHEER 30-40 MM HG KNEE HIGH CLOSED TOE LA...
AUTOCON II 400 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLEXI-Q DV AND DVR AUTO-INJECTORS
FDA 510(k)
FDA Class 2
·General Hospital
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929045206·Corpectomy, 12Dx14Wx67H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065013·Corpectomy, 12Dx14Wx67H 0°
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
SELECT SECURE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·January 6, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: 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 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 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·May 22, 2019