510(k) Clearances in 2020 — Page 56

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 56 of 59)
510(k) clearancesDetails
K191144 — Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies Jan 24, 2020
K193261 — FlightPlan for EmbolizationGE Medical Systems SCS Jan 24, 2020
K192641 — Gemini Titan Sterilization WrapMedline Industries, Inc. Jan 24, 2020
K192984 — APTUS Clavicle SystemMedartis AG Jan 24, 2020
K191227 — Paratrooper Plantar Plate Repair SystemParagon 28, Inc. Jan 24, 2020
K193109 — MRCAT brainPhilips Medical Systems MR Finland Jan 24, 2020
K192493 — BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. Jan 24, 2020
K191293 — LCCS VC-S RF CannulaLccs Products Limited Jan 24, 2020
K193454 — IQon Spectral CTPhilips Medical Systems Nederland B.V. Jan 24, 2020
K192025 — STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp) Jan 23, 2020
K190271 — FiteBac Cavity CleanserLargent Health, LLC Jan 23, 2020
K192530 — Surefil one Self-adhesive Composite HybridDentsply Sirona Jan 23, 2020
K192436 — Healing Abutments and Cover ScrewsDentium Co., Ltd. Jan 23, 2020
K191821 — Blue Phantom PTIba Dosimetry GmbH Jan 23, 2020
K191014 — Elements ViewerBrainlab AG Jan 23, 2020
K192170 — VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC Jan 23, 2020
K191270 — Proneb MaxPari Respiratory Equipment, Inc. Jan 23, 2020
K190839 — GammaTileGt Medical Technologies Jan 23, 2020
K192349 — Bactisure Wound LavageNext Science, LLC Jan 23, 2020
K190120 — VINNO 8, VINNO 6, VINNO 5Vinno Technology (Suzhou) Co.,Ltd Jan 23, 2020
K193504 — HardyDisk AST Cefiderocol 30ug (FDC30)Hardy Diagnostics Jan 23, 2020
K192330 — EEA Circular Stapler with Tri-Staple TechnologyCovidien Jan 23, 2020
K192092 — Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535Seca GmbH & Co. KG Jan 23, 2020
K193295 — Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC Jan 23, 2020
K192993 — SCARLET AL-TSpineart Jan 22, 2020
K193606 — Y-Knot OneStep AnchorConmed Corporation Jan 22, 2020
K191109 — Spectra QUzinmedicare Co. Jan 22, 2020
K193574 — Q-Rad SystemCarestream Health, Inc. Jan 22, 2020
K192684 — HydroPearl MicrospheresMicroVention, Inc. Jan 22, 2020
K191322 — E-EEGX, N-EEGXGE Healthcare Finland Oy Jan 22, 2020
K191093 — Isopure Dry Acid Dissolution SystemIsopure, Corp. Jan 22, 2020
K190837 — Internal Hex Implant SystemEbi, Inc. Jan 22, 2020
K192161 — FastFit EMS SystemFast Fit, LLC Jan 22, 2020
K190954 — Fundus CameraChongqing Bio Newvision Medical Equipment , Ltd. Jan 22, 2020
K192502 — Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar FusMedtronic Sofamor Danek USA, Inc. Jan 22, 2020
K192985 — Medline Glide-On 3G Vinyl Examination GlovesMedline Industries, Inc. Jan 21, 2020
K193370 — Nexxt Matrixx SystemNexxt Spine, LLC Jan 21, 2020
K191149 — CARESCAPE B650GE Healthcare Finland Oy Jan 21, 2020
K191425 — Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc. Jan 21, 2020
K193569 — PIVO(TM)Velano Vascular Jan 21, 2020
K192564 — Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc. Jan 21, 2020
K193566 — ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. Jan 21, 2020
K191229 — TrapItImds Operations B.V. Jan 21, 2020
K193222 — Tyber Medical Anatomical Plating SystemTyber Medical, LLC Jan 20, 2020
K192098 — EzMobileEwoosoft Co., Ltd. Jan 20, 2020
K193045 — geko™ W-2Firstkind Limited Jan 18, 2020
K193548 — Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jan 18, 2020
K190306 — AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. Jan 17, 2020
K192761 — Asimov-MKS Imaging SystemOnlume, Inc. Jan 17, 2020
K192415 — Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC Jan 17, 2020
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