510(k) Clearances in 2018 — Page 48

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 48 of 62)
510(k) clearancesDetails
K172354 — OssBuilder SystemOsstem Implant Co., Ltd. Mar 26, 2018
K173922 — C-PTFETM Surgical SutureCp Medical, Inc. Mar 26, 2018
K172035 — EKOS ultrasound EVD Device, EVD Control UnitBtg International, Inc. Mar 24, 2018
K172648 — Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC Mar 23, 2018
K173886 — CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS Mar 23, 2018
K173241 — MED-TABPlum Medical Solutions GmbH Mar 23, 2018
K172496 — SUPERCATH 5 (26G)Togo Medikit Co., Ltd. Mar 23, 2018
K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KG Mar 23, 2018
K180473 — ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DREcotron Co., Ltd. Mar 23, 2018
K170753 — Acculoc Total Knee SystemRootloc Co., Ltd. Mar 23, 2018
K172723 — Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd. Mar 23, 2018
K170410 — Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC Mar 23, 2018
K173425 — SRT-100+Sensus Healthcare, Inc. Mar 23, 2018
K180052 — UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa Mar 23, 2018
K173760 — Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. Mar 22, 2018
K180431 — Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc. Mar 22, 2018
K180453 — Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. Mar 22, 2018
K173128 — Alamo® CAlliance Partners, LLC Mar 22, 2018
K180486 — HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO Mar 22, 2018
K180443 — Tumark VisionSomatex Medical Technologies GmbH Mar 22, 2018
K172371 — Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc. Mar 22, 2018
K180074 — Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc. Mar 22, 2018
K173903 — Granada MediumHardy Diagnostics Mar 22, 2018
K180456 — Bio-Medicus Adult Cannulae KitMedtronic, Inc. Mar 22, 2018
K173134 — SENTIO MMG Pedicle Access NeedlesMedos International SARL Mar 22, 2018
K173915 — Test of Variables of Attention (T.O.V.A.)The Tova Company Mar 22, 2018
K173105 — Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated Mar 22, 2018
K172611 — Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengthsVarian Medical Systems, Inc. Mar 21, 2018
K163661 — P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilRapid Biomedical GmbH Mar 21, 2018
K171982 — DROPLET PEN NEEDLEHtl-Strefa S.A Mar 21, 2018
K180192 — Emprint Ablation Visualization ApplicationCovidien, LLC Mar 21, 2018
K173408 — Mammomat RevelationSiemens Medi Cal Solutions, Inc. Mar 21, 2018
K173571 — Element System with IBT ElectrodesInfinite Biomedical Technologies, LLC Mar 21, 2018
K172168 — WillCephHdx Will Corp. Mar 21, 2018
K173887 — cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. Mar 21, 2018
K171973 — Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. Mar 21, 2018
K180211 — FreezpointBovie Medical Corp. Mar 21, 2018
K180148 — ATS Thermal Imaging Probe, ATS Patient Interface UnitSecurus Medical Group, Inc. Mar 21, 2018
K173619 — Mimics inPrintMaterialise NV Mar 21, 2018
K180274 — Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. Mar 21, 2018
K180023 — WIRIONGardia Medical , Ltd. Mar 21, 2018
K173607 — SOMATOM Edge PlusSiemens Medical Solutions USA, Inc. Mar 21, 2018
K173846 — DermaScalp Laser CapDermascalp, LLC Mar 21, 2018
K173451 — Ingenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V. Mar 20, 2018
K170957 — ReConnex Pre-Sutured TendonAllosource Mar 20, 2018
K180165 — Habib EndoHPBEmcision , Ltd. Mar 20, 2018
K171989 — Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterWilson-Cook Medical, Inc. Mar 20, 2018
K180016 — Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd. Mar 20, 2018
K180015 — Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. Mar 20, 2018
K173919 — HX DeviceHuman Extension , Ltd. Mar 20, 2018
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