510(k) Clearances in 2021 — Page 25

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 25 of 61)
510(k) clearancesDetails
K211066 — Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3Homtex, Inc. Aug 19, 2021
K211576 — WYZ Surgical MaskWyz Medical Supplies, LLC Aug 19, 2021
DEN210013 — OsteoProbeActive Life Scientific, Inc. Aug 19, 2021
K202425 — SurgiLattice scaffoldTepha, Inc. Aug 19, 2021
K211319 — Purism Non-Sterile Powder Free Nitrile Examination GlovesDezhou Purism Medical Technology Co., Ltd. Aug 19, 2021
K210362 — s-Clean Pre-Milled AbutmentDentis Co., Ltd. Aug 19, 2021
K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A. Aug 19, 2021
K202652 — Servator P SALF Solution with THAMS.A.L.F. Spa Aug 19, 2021
K210256 — CiRx (R) Surgical MaskNingbo Shun YE Medical Company, Ltd. Aug 19, 2021
K211584 — Oral Surgery ContraNakanishi, Inc. Aug 19, 2021
K210317 — Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Aug 19, 2021
K212322 — Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies Aug 18, 2021
K211233 — Hailie Sensor NF0109Adherium (Nz), Ltd. Aug 18, 2021
K211957 — QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. Aug 18, 2021
K210318 — Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Aug 18, 2021
K211813 — TritonInter-Med / Vista Dental Aug 18, 2021
K211454 — Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd. Aug 18, 2021
K212097 — Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd. Aug 18, 2021
K203227 — Elecsys HCG STATRoche Diagnostics Aug 18, 2021
K211631 — Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. Aug 18, 2021
K210971 — EnteraLoc FlowVonco Products Aug 18, 2021
K211513 — sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC Aug 18, 2021
K203820 — ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA Aug 17, 2021
K210998 — ROSA Hip SystemOrthosoft D/B/A Zimmer Cas Aug 17, 2021
K211671 — Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. Aug 17, 2021
K211376 — STARbandOrthomerica Products, Inc. Aug 17, 2021
K211708 — Disposable Medical Nitrile GlovesJiangsu Health-Peace Medical Technology Co., Ltd. Aug 17, 2021
K201573 — Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. Aug 17, 2021
K210201 — Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway , Ltd. Aug 17, 2021
K203089 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Aug 17, 2021
K210569 — Disposable Monopolar Laparoscopic Shafts and Reusable HandlesDannik, LLC Aug 16, 2021
K212066 — Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. Aug 16, 2021
K202636 — Metallic Fabric ElectrodesGuangzhou Xinbo Electronic Co., Ltd. Aug 16, 2021
K212230 — TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd. Aug 16, 2021
K203236 — Rhino Health Non-Sterile, Powder-free Nitrile Exam GloveRhino Health, Inc. Aug 16, 2021
K211654 — Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. Aug 16, 2021
K211294 — Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. Aug 16, 2021
K211703 — Insignia Hip StemStryker Orthopaedics Aug 16, 2021
K201094 — iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc. Aug 16, 2021
K210841 — NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc. Aug 16, 2021
K210695 — CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC Aug 16, 2021
K210381 — I.V. Administration SetBq Plus Medical Co., Ltd. Aug 14, 2021
K211383 — NFLK-2501 Portable X-ray UnitNeuf, Inc. Aug 13, 2021
K203817 — Tyber Medical Anatomical Plating SystemTyber Medical, LLC Aug 13, 2021
K202279 — Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC Aug 13, 2021
K200913 — Clearblue® Early Digital Pregnancy TestSpd Swiss Precision Diagnostics GmbH Aug 13, 2021
K211777 — ARCO FP-SA.T.S. Applicazione Tecnologie Speciali S.R.L. Aug 13, 2021
K203693 — Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC Aug 13, 2021
K210671 — Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107Weony (Shenzhen) Technology Co., Ltd. Aug 13, 2021
K210858 — VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. Aug 13, 2021
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