242 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Augment Off-Axis Instrument System
FDA 510(k)
FDA Class 2
·Orthopedic
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
3N Contact Lenses Adjunct Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
ePM Series Patient monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Passport Series Patient Monitors(Passport 12m, Passport 17m)
FDA 510(k)
FDA Class 2
·Cardiovascular
ePM Series Patient monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
V Series Monitoring System (including V12 and V21 Monitors)
FDA 510(k)
FDA Class 2
·Cardiovascular
TK Insulin Syringe with/without Saftey Retractable Device
FDA 510(k)
FDA Class 2
·General Hospital
BeneVision Central Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Accutorr 7/VS-900 Vital Signs Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Mindray SV600 Ventilator, Mindray SV800 Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
TK Sterile Piston Syringe without Needle
FDA 510(k)
FDA Class 2
·General Hospital
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
FDA 510(k)
FDA Class 2
·Cardiovascular
Doppler FHR Detector (BF-500D+, BF-560)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
A5 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
TK Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Passport Series Patient Monitors (Including Passport 8, Passport 12)
FDA 510(k)
FDA Class 2
·Cardiovascular
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
FDA 510(k)
FDA Class 2
·Cardiovascular
Vital Signs Monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
TK Pre-Filled Normal Saline Flush Syringe
FDA 510(k)
FDA Class 2
·General Hospital