510(k) Clearances in 2019 — Page 29

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 29 of 59)
510(k) clearancesDetails
K191053 — Xtreme-LoopXiros, Ltd. Jul 17, 2019
K191068 — Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. Jul 17, 2019
K183270 — Silent Nite slPrismatik Dentalcraft, Inc. Jul 17, 2019
K191616 — Orthophos SDentsply Sirona Jul 16, 2019
K190150 — Sage 2-in-1 Personal Lubricant and MoisturizerFairhaven Health, LLC Jul 16, 2019
K190575 — iBreastExamUe Lifesciences, Inc. Jul 16, 2019
K183572 — FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation Jul 16, 2019
K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated Jul 16, 2019
K190163 — ALARA Neuro Access KitSurGenTec, LLC Jul 16, 2019
K180992 — BiotexPurgo Biologics, Inc. Jul 16, 2019
K183663 — Microlife Digital Infrared Ear ThermometerMicrolife Intellectual Property GmbH Jul 16, 2019
K191325 — EMPOWR Partial KneeEncore Medical L.P. Jul 16, 2019
K191287 — OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 FastenersDavol Inc., Subsidiary Of C.R. Bard Jul 16, 2019
K191608 — Impress Angiographic CatheterMerit Medical Systems, Inc. Jul 16, 2019
K191635 — Optilite IgM KitThe Binding Site Group , Ltd. Jul 15, 2019
K190749 — 087 Balloon Guide Catheter SystemQ'Apel Jul 15, 2019
K182455 — A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device , Ltd. Jul 15, 2019
K191372 — LyraInteracoustics A/S Jul 15, 2019
K190123 — MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc. Jul 15, 2019
K182158 — UNiD Patient-matched PLIF cageMedicrea International SA Jul 15, 2019
K182814 — Rael TamponRael, Inc. Jul 15, 2019
K183325 — Modus NavSynaptive Medical, Inc. Jul 14, 2019
K173974 — DROWZLEResonea, Inc. Jul 14, 2019
K182930 — PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. Jul 12, 2019
K191601 — Valleylab FT10 Electrosurgical PlatformCovidien Jul 12, 2019
K190457 — VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. Jul 12, 2019
K191272 — Wearable Device, Wearable PackageCurrent Health , Ltd. Jul 12, 2019
K190976 — Radial Medical Compression SystemRadial Medical, Inc. Jul 12, 2019
K191050 — MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) WorkflowSiemens Medical Solutions USA, Inc. Jul 12, 2019
K191317 — StitchKitOrigami Surgical Jul 12, 2019
K182714 — Novidia Bulk Fill Flow CompositeNobio , Ltd. Jul 12, 2019
K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc. Jul 12, 2019
K182091 — Osstem Abutment SystemOsstem Implant Co., Ltd. Jul 12, 2019
K191259 — Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. Jul 12, 2019
K190972 — Ambu aScope 4 RhinoLaryngo InterventionAmbu A/S Jul 12, 2019
K191585 — iNtuition-Structural Heart ModuleTerarecon,Inc. Jul 12, 2019
K183473 — AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. Jul 12, 2019
K190999 — SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. Jul 12, 2019
K191482 — Senhance Surgical SystemTransenterix, Inc. Jul 11, 2019
K181418 — ScopeFlow Pure(TM)Partnership Medical Limited Jul 11, 2019
K191534 — ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. Jul 11, 2019
K191579 — Voyant SystemViseon, Inc. Jul 11, 2019
K190960 — Nalu Lead Blank (50cm)Boston Scientific Neuromodulation Jul 11, 2019
K190718 — Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A. Jul 11, 2019
K191138 — AeroForm Tissue Expander, SmoothAirxpanders, Inc. Jul 11, 2019
K181457 — EndoStream(TM)Partnership Medical Limited Jul 11, 2019
K191594 — Nuvis Battery ArthroscopeIntegrated Endoscopy, Inc. Jul 11, 2019
K182854 — GC FujiCEM 2 (Improved)GC America, Inc. Jul 11, 2019
K190229 — Stryker PEEK Customized Cranial Implant KitStryker Jul 11, 2019
K190694 — Unifi Workspace v1.0.0Hologic, Inc. Jul 11, 2019
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