510(k) Clearances in 2021 — Page 44

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 44 of 61)
510(k) clearancesDetails
K210988 — Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. Apr 21, 2021
K202759 — Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd. Apr 21, 2021
K210483 — MOBIO Total Knee SystemB-One Ortho, Corp. Apr 21, 2021
K210867 — NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. Apr 21, 2021
K202639 — si-MochiBiostone, Ltd. Apr 21, 2021
K210145 — Nitrile Glove Powder Free BlueChangzhou Universal Medical Equipment Co., Ltd. Apr 21, 2021
K202750 — Knee+Pixee Medical Apr 21, 2021
K210556 — Preview ShoulderGenesis Software Innovations Apr 21, 2021
K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)Biocompatibles UK Ltd (Part Of Boston Scientific Corporation Apr 20, 2021
K203610 — Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC Apr 20, 2021
K203596 — Panthera Occlusal AppliancePanthera Dental, Inc. Apr 20, 2021
K203489 — SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation Apr 20, 2021
K210427 — M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A. Apr 20, 2021
K210157 — SOLE Medial Column Fusion PlateOrthofix Srl Apr 20, 2021
K203805 — Disposable Nitrile Examination GlovesJiangsu Yanfang Medical Technology Co., Ltd. Apr 20, 2021
K210835 — IdentifyVarian Medical Systems, Inc. Apr 20, 2021
K210839 — SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc. Apr 20, 2021
K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB Apr 20, 2021
K203824 — VPS Impression MaterialHygedent, Inc. Apr 19, 2021
K202506 — Karma Powered WheelchairKarma Medical Products Co., Ltd. Apr 19, 2021
K203421 — Triathlon AS-1Conformis, Inc. Apr 19, 2021
K203644 — Solevy Co. LLC Silicone Based Personal LubricantSolevy Co., LLC Apr 19, 2021
K203469 — AI SegmentationVarian Medical Systems, Inc. Apr 19, 2021
K210134 — Dentis s-Clean s-LineDentis Co., Ltd. Apr 19, 2021
K210420 — Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. Apr 19, 2021
K203495 — Arthrex SwiveLock AnchorArthrex, Inc. Apr 19, 2021
K210121 — ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas Apr 19, 2021
K203473 — SOZOImpediMed Limited Apr 19, 2021
K203654 — Solevy Co. LLC Water-Based Personal LubricantSolevy Co., LLC Apr 19, 2021
K203517 — Saige-QDeepHealth, Inc. Apr 16, 2021
K201047 — Fusion Taper SystemSignature Orthopaedics Pty, Ltd. Apr 16, 2021
K200270 — rainbow MCTDentium Co., Ltd (Ict Branch) Apr 16, 2021
K202419 — BIOTECH Nitrile Examination GlovesTk Hitech Technology Co., Ltd. Apr 16, 2021
K200271 — rainbow CTDentium Co., Ltd (Ict Branch) Apr 16, 2021
K203170 — Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd. Apr 16, 2021
K210276 — Disposable Nitrile GlovesFujian Ercon Medical Management Co., Ltd. Apr 16, 2021
K210600 — MOLLIMolli Surgical, Inc. Apr 16, 2021
K202055 — Looper (Model: ZX-579S)Heat IN A Click, LLC Apr 16, 2021
K203616 — Brainsway Deep (DTMS) SystemBrainsway , Ltd. Apr 16, 2021
K210169 — Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd. Apr 16, 2021
K200978 — Electric Wheelchair (Model: S7110)Dongguan Prestige Sporting Goods Co., Ltd. Apr 16, 2021
K203315 — BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. Apr 15, 2021
K210808 — Instylla Microcatheter 1.2Instylla, Inc. Apr 15, 2021
K202403 — SKORE (Colors & Flavors), SKORE (Colors)Ttk Healthcare Limited Apr 15, 2021
K203132 — AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation Apr 15, 2021
K202830 — Axiostat PatchAdvamedica, Inc. Apr 15, 2021
K210235 — Verrata PLUS Pressure Guide WireVolcano Corporation Apr 15, 2021
K203701 — Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors, LLC Apr 15, 2021
K210539 — CoreLink Midline Fixation SystemCorelink, LLC Apr 15, 2021
K201718 — GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd. Apr 15, 2021
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