476 results
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33ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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RANDOX ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BMR FACE
FDA 510(k)
FDA Class 2
·Neurology
GI Genius System 100 and GI Genius System 200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVA 15 Insufflator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYSTEM-ARMS, MODELS 390, X60
FDA 510(k)
FDA Class 2
·Physical Medicine
ROTO REST; TRAUMA AND INTENSIVE CARE BED
FDA 510(k)
FDA Class 2
·Physical Medicine
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
FDA 510(k)
FDA Class 2
·Orthopedic
GLOBAL UNITE Platform Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
pRESET LITE Thrombectomy Device
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOBAL UNITE Platform Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
BANTAM CATHETER (280MM BALLOON LENGTHS)
FDA 510(k)
FDA Class 2
·Cardiovascular
PLASMATRODE SALINE SAFE TUR ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Cathivex ¿GV filter units
FDA 510(k)
FDA Class 2
·General Hospital
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Halo One Thin-Walled Guiding Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX MYOGLOBIN
FDA 510(k)
FDA Class 2
·Immunology