510(k) Clearances in 2018 — Page 58

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 58 of 62)
510(k) clearancesDetails
K173285 — JOULE SYSTEMSciton, Inc Jan 29, 2018
K173466 — Panthera Dental Milled BarsPanthera Dental, Inc. Jan 26, 2018
K172896 — Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312Shenzhen Jiacom Technology CO ., Ltd. Jan 26, 2018
K173430 — SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. Jan 26, 2018
K173558 — SyMRISyntheticmr AB Jan 26, 2018
K173843 — illumiflow 148 Laser CapEglobal, LLC Jan 26, 2018
K173382 — Vantage Galan 3T, V4.6Toshibamedical Systems Corporation Jan 26, 2018
K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. Jan 26, 2018
K172716 — V2K Rinspiration SystemV2K Medical, Inc. Jan 26, 2018
K162665 — MiCor A100 Wearable ECG RecorderMitac International Corp. Jan 26, 2018
K171367 — SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)Sanrea Healthcare Products Pvt, Ltd. Jan 26, 2018
K171391 — Stryker 90-S Max SERFAS Energy ProbeStryker Jan 26, 2018
K172890 — SedLine Sedation MonitorMasimo Corporation Jan 26, 2018
K173955 — Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. Jan 26, 2018
K172969 — Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. Jan 26, 2018
K173953 — uDR 780iShanghai United Imaging Healthcare Co., Ltd. Jan 26, 2018
K172816 — TiGer Shark™ SystemChoicespine, LP Jan 26, 2018
K173299 — DRAGON X SPSL4HC, DRAGON X SPSL8HCSedecal., Sa. Jan 26, 2018
K172935 — EmbraceEmpatica S.R.L. Jan 26, 2018
K173709 — Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. Jan 26, 2018
K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B. Jan 25, 2018
K171264 — Royal Flush CatheterCook Incorporated Jan 25, 2018
K172116 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)Stryker Corporation Jan 25, 2018
K173542 — Arterys Oncology DLArterys, Inc. Jan 25, 2018
K173060 — F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher And Paykel Healthcare Limited Jan 25, 2018
K171954 — ClearLine IVClearline MD Jan 25, 2018
K173581 — Gallant PTCA Dilatation CatheterMedinol, Ltd. Jan 25, 2018
K173448 — CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) Jan 25, 2018
K173062 — Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation Jan 25, 2018
K171968 — EchoGlo NeedleSmiths Medical Asd, Inc. Jan 25, 2018
K173521 — SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation Jan 24, 2018
K173876 — Cybird LED Curing LightDxm Co., Ltd. Jan 24, 2018
K173196 — SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd. Jan 24, 2018
K173363 — Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC Jan 24, 2018
K171528 — Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)Avantsonic Technology Co., Ltd. Jan 24, 2018
K171942 — ElectrocardiographEdan Instruments, Inc. Jan 24, 2018
K163684 — C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. Jan 23, 2018
K172304 — TruAbutment DSTruabutment, Inc. Jan 23, 2018
K173442 — gammaCore-SElectrocore, LLC Jan 23, 2018
K171789 — ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie Jan 23, 2018
K173219 — CAMPYLOBACTER CHEKTechlab, Inc. Jan 22, 2018
K173235 — Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support ProfileScientia Vascular, LLC Jan 22, 2018
K171360 — CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd Jan 22, 2018
K173306 — EZ PlateZavation Medical Products, LLC Jan 22, 2018
K163600 — Kit Boxes and Kit PlatesNobel Biocare AB Jan 22, 2018
K173217 — CAMPYLOBACTER QUIK CHEKTechlab, Inc. Jan 22, 2018
K173584 — 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader3M Company Jan 22, 2018
K172920 — 3D APTPhilips Medical Systems Nederland B.V. Jan 22, 2018
K180025 — Centurion POCT SystemOrthofix, Inc. Jan 22, 2018
K171312 — FortiCore®Nanovis, LLC Jan 22, 2018
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