923 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
FDA 510(k)
FDA Class 2
·Radiology
DIRECT DIGITIZER, REGIUS MODEL 190
FDA 510(k)
FDA Class 2
·Radiology
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RespiraSense
FDA 510(k)
FDA Class 2
·Anesthesiology
HealthBeacon HB2 Sharps Bin
FDA 510(k)
FDA Class 2
·General Hospital
Simple 2 Test
FDA 510(k)
FDA Class 2
·Microbiology
STREAMER POLYMER GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Vitalograph Model 6600 Compact
FDA 510(k)
FDA Class 2
·Anesthesiology
OLYMPUS CK-MB REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMYLASE (ETHYLIDENE PNGPG7) KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
FDA 510(k)
FDA Class 2
·Neurology
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Total Bilirubin2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVA15 insufflator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GI Genius
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EntericBio Dx Assay
FDA 510(k)
FDA Class 2
·Microbiology
NEUROMARK System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLOBAL ICON Stemless Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic