510(k) Clearances in 2021 — Page 17

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 17 of 61)
510(k) clearancesDetails
K210562 — HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd. Oct 1, 2021
K212828 — BRIUS Planner SoftwareBrius Technologies, Inc. Oct 1, 2021
K212794 — Accuray Precision Treatment Planning SystemAccuray Incorporated Sep 30, 2021
K212227 — Philips MR Patient Care PortalInvivo Corporation Sep 30, 2021
K211593 — Enteral Pump SyringeJiangsu Caina Medical Co.,Ltd Sep 30, 2021
K211450 — Playboy 3 Contour CondomThai Nippon Rubber Industry Public Company Limited. Sep 30, 2021
K211591 — NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc. Sep 30, 2021
K212757 — Jada SystemAlydia Health Sep 30, 2021
K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH Sep 30, 2021
K203609 — Intravascular Administration SetsBaxter Healthcare Corporation Sep 30, 2021
K210523 — ImplanovaDental Evolutions, Inc. Sep 30, 2021
K191288 — Acuitas AMR Gene PanelOpgen, Inc. Sep 30, 2021
K211935 — ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC Sep 30, 2021
K211439 — Small Bone Nailing SystemSkeletal Dynamics, Inc. Sep 30, 2021
K212405 — EMERGE™ Anterior Cervical Plate SystemEvolution Spine Sep 30, 2021
K212805 — SteriCap Mini Needle and Standard NeedlesOcuject, LLC Sep 30, 2021
K212386 — AngioVac F18 85AngioDynamics, Inc. Sep 30, 2021
K203350 — ENDOtubeNissha Medical Technologies Sas Sep 29, 2021
K211740 — DualXAmplify Surgical, Inc. Sep 29, 2021
K200639 — LAP-iXSejong Medical Co., Ltd. Sep 29, 2021
K211781 — Disposable Nitrile GlovesJiangsu Jinke Protective Equipment Co., Ltd. Sep 29, 2021
K210726 — ImmersiveTouchImmersivetouch, Inc. Sep 29, 2021
K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas Sep 29, 2021
K212226 — DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd. Sep 29, 2021
K210590 — Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. Sep 29, 2021
K210763 — Inman Digital Clear AlignersInman Orthodontic Laboratories, Inc. Sep 29, 2021
K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal NeedlesMyco Medical Supplies, Inc. Sep 29, 2021
K210513 — UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2Universal Incorporation Sep 29, 2021
K212747 — Da Vinci SP Surgical SystemIntuitive Surgical, Inc. Sep 29, 2021
K212238 — TheraFace MicrocurrentTheragun, Inc. Sep 29, 2021
K211964 — SubtlePETSubtle Medical, Inc. Sep 28, 2021
K210894 — SIDDHARTH-II; IMPACTPanacea Medical Technologies Pvt. , Ltd. Sep 28, 2021
K202481 — ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd. Sep 28, 2021
K211760 — Panther OISProwess, Inc. Sep 28, 2021
K210561 — Advisor Pro PlatformDreaMed Diabetes, Ltd. Sep 28, 2021
K212129 — Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH Sep 28, 2021
K211794 — Disposable surgical maskShanghai No.9 Knitting Mill Co., Ltd. Sep 28, 2021
K212045 — SoftSpotPediametrix, Inc. Sep 28, 2021
K210878 — Surgical Face Mask (Model: CM2006, CM2008, A88)Shenzhen Realtone Medical Appliance Co., Ltd. Sep 28, 2021
K212320 — Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac3M Healthcare Business Group Sep 28, 2021
K211700 — EzDent WebEwoosoft Co., Ltd. Sep 28, 2021
K201855 — Electrically Powered Wheelchair -Model HP358EKunshan Hi-Fortune Health Products Co., Ltd. Sep 28, 2021
K211236 — Disposable Vinyl Examination GlovesTangshan Hongyun Healthcare Products Co., Ltd. Sep 27, 2021
K212080 — Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. Sep 27, 2021
K212643 — POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America Sep 27, 2021
K212750 — Ultrasonic Surgical Aspirator System, Model: XD880BSmtp Technology Co., Ltd. Sep 27, 2021
K212028 — Dark Star Navigation Instrument SystemRepublic Spine, LLC Sep 27, 2021
K212738 — Amplatzer Talisman Delivery SheathABBOTT MEDICAL Sep 27, 2021
K203674 — B Dispensing LineAea Srl Sep 27, 2021
K212026 — Amplatzer Steerable Delivery SheathABBOTT MEDICAL Sep 27, 2021
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