12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ATB ADVANCE PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Aveta Waste Management Accessory
FDA UDI
MEDITRINA, INC.·00850006759699·Aveta Waste Management Accessory for use with A...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400520360·Anterior Dome Osteotomy Guide, 52mm x 36mm
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
FDA 510(k)
FDA Class 2
·Cardiovascular
SIEMENS VIRTUAL SIMULATION (VSIM)
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II Y 22GAX1.00IN PRN EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·August 26, 2024
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
ADMIRAL XTREME
FDA Adverse Event
Malfunction
·INVATEC SPA·Product code LIT·April 11, 2013
CONTINUOUS NERVE BLOCK KIT: 19 GA X 24 IN
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·March 2, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 21, 2008
HEARTWARE VENTRICULAR ASSIST SYSTEM - SEWING RING
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·May 8, 2018
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017