476 results · 33ms · Sources: EU EUDAMED, US FDA

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