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510(k) Clearances in 2018 — Page 62
3,062 510(k) clearances total
Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.
510(k) Clearances in 2018 (page 62 of 62)
| 510(k) clearances | Details |
| K171836 — EarlySense Bed Sensing Unit | Earlysense, Ltd. Jan 4, 2018 |
| K171056 — WAVE Clinical Platform | Excel Medical Electronics, LLC Jan 4, 2018 |
| K171235 — OmniCap | Respirion, Inc. Jan 4, 2018 |
| K171113 — LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | Lina Medical Aps Jan 4, 2018 |
| K173198 — Facet Screw Fixation System | U&I Corporation Jan 3, 2018 |
| K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | Biomet Manufacturing Corp Jan 3, 2018 |
| K173702 — Juliet Ti LL | Spineart Jan 3, 2018 |
| K172798 — Straumann CARES Abutments CoCr | Institut Straumann AG Jan 3, 2018 |
| K170924 — AirFit F20 | Resmed, Ltd. Jan 3, 2018 |
| K163712 — Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. Jan 2, 2018 |
| K172860 — Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 2, 2018 |
| K171529 — Snorer's Friend | Scope Healthcare Technologies Pty, Ltd. Jan 2, 2018 |