510(k) Clearances in 2018 — Page 33

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 33 of 62)
510(k) clearancesDetails
K180847 — Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc. Jun 19, 2018
K180472 — ViSi Mobile Monitoring SystemSotera Wireless, Inc. Jun 19, 2018
K180856 — Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. Jun 19, 2018
K172346 — sterEOS WorkstationEos Imaging Jun 19, 2018
K180710 — Reprocessed DecaNav Diagnostic Electrophysiology CatheterInnovative Health, LLC Jun 19, 2018
K173700 — PICOPLUS Laser SystemLutronic Corporation Jun 19, 2018
K173316 — SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy DeviceTransmed7, LLC Jun 19, 2018
K180560 — Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. Jun 18, 2018
K172345 — IU Implant SystemWarantec Co., Ltd. Jun 18, 2018
K172895 — AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819Ageless Health Industrial Co., Ltd. Jun 18, 2018
K181484 — Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueZirkonzahn Srl Jun 18, 2018
K180761 — SD LTM STIM Cortical StimulatorMicromed S.P.A. Jun 18, 2018
K172842 — GCE704 Breast PumpGlobalcare Jun 18, 2018
K180726 — Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc. Jun 18, 2018
K181325 — FlowTriever Retrieval/Aspiration SystemInari Medical, Inc. Jun 17, 2018
K180497 — Scone MaskResmed, Ltd. Jun 15, 2018
K181113 — CoLink™ Afx Plating SystemIn2Bones USA, LLC Jun 15, 2018
K173936 — Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Jun 15, 2018
K172551 — Trinity PLUS Acetabular ShellCorin U.S.A. Limited Jun 15, 2018
K181290 — Fusion Bx 2.0Focal Healthcare, Inc. Jun 15, 2018
K172954 — Medline Prevention CoolZone GownMedline Industries, Inc. Jun 15, 2018
K173507 — Prodiva 1.5T CX and Prodiva 1.5T CS R5.4Philips Healthcare (Suzhou) Co., Ltd. Jun 15, 2018
K173225 — Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem Jun 15, 2018
K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development Jun 15, 2018
K180749 — Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. Jun 15, 2018
K173908 — DESS Dental Smart SolutionsTerrats Medical SL Jun 15, 2018
K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsSmiths Medical Asd, Inc. Jun 14, 2018
K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc. Jun 14, 2018
K173455 — SurgTech Bipolar Head SystemSurgtech, Inc. Jun 14, 2018
K180100 — MRIaudio PREM SystemMriaudio Jun 14, 2018
K180813 — BTL 799-2BTL Industries, Inc. Jun 14, 2018
K172011 — LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc. Jun 14, 2018
K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. Jun 14, 2018
K181351 — Double Flexible Tipped Wire GuidesCook Incorporated Jun 14, 2018
K180719 — InMode Diolaze SystemInmode MD , Ltd. Jun 14, 2018
K172938 — Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd Jun 14, 2018
K180290 — Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Jun 14, 2018
K173376 — ASI EvolutionArlington Scientific, Inc. (Asi) Jun 14, 2018
K172787 — Access hsTnlBeckman Coulter, Inc. Jun 14, 2018
K180401 — TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC Jun 14, 2018
K173977 — CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleBiosense Webster, Inc. Jun 14, 2018
K181316 — POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. Jun 14, 2018
K180505 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)Hartalega Sdn Bhd Jun 14, 2018
K181301 — Smart External Drain (SED) SystemAqueduct Critical Care, Inc. Jun 14, 2018
K173780 — EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. Jun 14, 2018
K180738 — COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary CatheterCompactcath, Inc. Jun 14, 2018
K172985 — Ligation DeviceLeo Medical Co., Ltd. Jun 14, 2018
K180675 — Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc. Jun 13, 2018
K180565 — PEAK NS033CF, PEAK NS017CFNeosil Co., Ltd. Jun 13, 2018
K181429 — CELERITY 20 HP Biological IndicatorSTERIS Corporation Jun 13, 2018
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