510(k) Clearances in 2021 — Page 58

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 58 of 61)
510(k) clearancesDetails
K201016 — LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)Huizhou Foryou Medical Devices Co., Ltd. Jan 28, 2021
K200384 — HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc. Jan 28, 2021
K203223 — Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris Jan 28, 2021
K201608 — GenesisZr UHT700 ZirconiaUnited Dental Resources Corporation Jan 28, 2021
K202524 — Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC Jan 28, 2021
K203405 — EVOS Large Fragment Plating SystemSmith & Nephew, Inc. Jan 27, 2021
K193386 — Wrist Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. Jan 27, 2021
K193387 — Arm Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. Jan 27, 2021
K193586 — Vivo 45 LSBreas Medical AB Jan 27, 2021
K203803 — VASOBand Vascular Compression DeviceVasoinnovations, Inc. Jan 26, 2021
K203482 — M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. Jan 26, 2021
K200922 — Altus Spine HA Pedicle Screw SystemAltus Partners, LLC Jan 26, 2021
K202199 — BTL-899STBtl Jan 26, 2021
K203104 — IBM iConnect AccessMerge Healthcare Incorporated Jan 26, 2021
K201300 — Airway MobilescopeOlympus Medical Systems Corp. Jan 26, 2021
K203849 — General Radiography CXDI-CS01Canon, Inc. Jan 26, 2021
K202934 — Blood Pressure MonitorBioland Technology, Ltd. Jan 26, 2021
K202742 — Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix , Ltd. Jan 25, 2021
K203747 — Non-Contact Forehead Thermometer (Models UT306H & UT308H)Uni-Trend Technology (China) Co., Ltd. Jan 25, 2021
K203327 — VERTACONNECT TLIF CageSignus Medizintechnik Jan 25, 2021
K203797 — vatech A9 (Model : PHT-30CSS)VATECH Co., Ltd. Jan 25, 2021
K201468 — Pulse OximeterShenzhen Creative Industry Co., Ltd. Jan 25, 2021
K202856 — Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28Edan Instruments, Inc. Jan 25, 2021
K203453 — BD Hypodermic SyringeBecton, Dickinson And Company Jan 25, 2021
K201187 — Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. Jan 23, 2021
K202336 — Patient MonitorEdan Instruments, Inc. Jan 23, 2021
K202660 — SPRINT PNS SystemSpr Therapeutics, Inc. Jan 22, 2021
K203373 — Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC Jan 22, 2021
K200037 — Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. Jan 22, 2021
K203656 — Non-Contact Forehead Thermometer (UT30H)Uni-Trend Technology (China) Co., Ltd. Jan 22, 2021
K202858 — Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC Jan 22, 2021
K201553 — Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC Jan 22, 2021
K203181 — Nerivio, FGD000075-4.7Theranica Bioelectronics , Ltd. Jan 22, 2021
K203010 — Platinum dRF Imaging SystemApelem-Dms Group Jan 22, 2021
K201696 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft LengthEthicon Endo-Surgery, LLC Jan 22, 2021
K202575 — ClearPoint Array SystemClearPoint Neuro, Inc. Jan 22, 2021
K193266 — MIINMedico USA, Inc. Jan 22, 2021
K202415 — VirtueRFShenB Co., Ltd. Jan 22, 2021
K202792 — BRIUS Clear AlignersBrius Technologies, Inc. Jan 22, 2021
K202640 — Surgical MaskJiangsu Medpure Biological Technology Co., Ltd. Jan 22, 2021
K201782 — NuFace Trinity Plus DeviceCarol Cole Company Dba Nuface Jan 22, 2021
K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC Jan 22, 2021
K201066 — ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft LengthEthicon Endo-Surgery, LLC Jan 22, 2021
K202904 — Surgical Face MaskJiangxi Feilikang Medical Technology Co., Ltd. Jan 21, 2021
K201366 — ForwartsPronova Laboratories BV Jan 21, 2021
K200731 — pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5Pjur Group Luxembourg S.A. Jan 21, 2021
K202672 — Precision Delivery Infusion SetQuest Medical, Inc. Jan 21, 2021
K202595 — Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC Jan 21, 2021
K202507 — EEA Circular Stapler with Tri-Staple TechnologyCovidien Jan 21, 2021
K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. Jan 21, 2021
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