539 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
PVC Hydrophilic Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
InferRead Lung CT.AI
FDA 510(k)
FDA Class 2
·Radiology
PerfusionGo Plus
FDA 510(k)
FDA Class 2
·Radiology
SoftFix Balloon Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medical Surgical Mask (Model: JM92, JM92B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AmCAD-UO
FDA 510(k)
FDA Class 2
·Radiology
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Medical Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cystoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Wrist - Type Fully Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE
FDA 510(k)
FDA Class 2
·Ophthalmic
Afinion HbA1c Dx on Afinion 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Afinion HbA1c Dx
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Fractional CO2 Laser Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
FDA 510(k)
FDA Class 2
·Cardiovascular