510(k) Clearances in 2021 — Page 39

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 39 of 61)
510(k) clearancesDetails
K210535 — UltraLight LED SystemRohrer Aesthetics, LLC May 24, 2021
K210214 — NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated May 24, 2021
K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated May 24, 2021
K211246 — LEGION CR Porous Plus HA Femoral ComponentsSmith & Nephew, Inc. May 24, 2021
K190703 — Neuro-IOM system with Neuro-IOM.NET softwareNeurosoft , Ltd. May 22, 2021
K211312 — Universal ViewerGE Healthcare May 21, 2021
K202299 — Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd. May 21, 2021
K201192 — Impla-NX (Model: ISE-270M)Micro-Nx Co., Ltd. May 21, 2021
K202359 — Zio MonitoriRhythm Technologies, Inc. May 21, 2021
K211273 — Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayEthicon Endo-Surgery, LLC May 21, 2021
K201461 — Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd May 21, 2021
K210119 — IPL Hair Removal Device (Model: KCA423)Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. May 21, 2021
K202527 — Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc. May 21, 2021
K203806 — JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. May 21, 2021
K211423 — RoverMicro-X Limited May 21, 2021
K210358 — Neurescue deviceNeurescue Aps May 21, 2021
K202919 — ATS 5000 Automatic Tourniquet InstrumentMcewen And Associates Consulting , Ltd. May 20, 2021
K210086 — Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. May 20, 2021
K210581 — Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC May 20, 2021
K203415 — Surgical Isolation GownYanbian Pacific Textile Co., Ltd. May 20, 2021
K203440 — Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. May 20, 2021
K202716 — Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC May 20, 2021
K211001 — C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerMedtec, Inc. Dba Civco Medical Solutions And Civco May 20, 2021
K210257 — Xoran Workstation, Model 10050Xoran Technologies, LLC May 20, 2021
K203583 — YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. May 20, 2021
K202899 — Procedure Mask, Surgical MaskKenpax International Limited May 20, 2021
K203377 — VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc. May 20, 2021
K203331 — Quick-20mCgx, LLC May 20, 2021
K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. May 20, 2021
K210553 — Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. May 19, 2021
K202955 — Contour Light CL-100Contour Research, LLC May 19, 2021
K201569 — CUVIS-spineCurexo, Inc. May 19, 2021
K210880 — Vereos PET/CTPhilips Medical Systems Nederland B.V. May 19, 2021
K210237 — CINA CHESTAvicenna.Ai May 19, 2021
K202866 — TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd. May 19, 2021
K210394 — Electrosurgical accessoryDornier Medtech America, Inc. May 19, 2021
K201576 — Disposable Latex Powder Free Examination Gloves (Non-sterile)Pt. Universal Gloves May 19, 2021
K210306 — GII Spinal Fixation SystemColigne AG May 19, 2021
K203282 — TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S May 19, 2021
K210187 — Overjet Dental AssistOverjet, Inc. May 19, 2021
K202593 — Turbett Instrument PodTurbett Surgical, Inc. May 19, 2021
K210540 — Ohlendorf Clear AlignerOhlendorf Appliance Laboratory May 19, 2021
K210816 — True Tulip, True M.I.S.Innovative Surgical Designs, Inc. May 18, 2021
K202423 — MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)Beckman Coulter, Inc. May 18, 2021
K202458 — BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH May 18, 2021
K202667 — Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc. May 18, 2021
K210829 — Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. May 18, 2021
K202709 — Disposable Powered Endoscopic Linear Cutting Staplers and CartridgesNingbo Verykind Medical Device Co., Ltd. May 18, 2021
K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Winter & Ibe GmbH May 17, 2021
K210460 — NitriTec Vinyl Glove Powder Free BlueZhonghong Pulin Medical Products Co., Ltd. May 17, 2021
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