510(k) Clearances — Page 154

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 154 of 3,525)
ClearancesDetails
K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)Acula Technology Corp. May 21, 2024
K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)Tianjin Huahong Technology Co., Ltd. May 21, 2024
K232677 — Reia pessaryReia, LLC May 21, 2024
DEN230068 — 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 11903M Company May 21, 2024
K240520 — Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science And Technologyco.Ltd May 20, 2024
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences May 20, 2024
K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)Covidien, LLC May 20, 2024
K233620 — MIM - Centiloid ScalingMim Software, Inc. May 20, 2024
K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)Hunan Ceramaster Material Technology Co., Ltd. May 20, 2024
K240511 — Dentis s-Clean SQ-SL FixtureDentis Co., Ltd. May 20, 2024
K223399 — AViTA Pulse OximeterAvita Corporation May 20, 2024
K241276 — Vector™ Pedicle Screw SystemInnovasis, Inc. May 20, 2024
K240474 — Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd May 20, 2024
K241252 — Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd. May 20, 2024
K232702 — Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac May 20, 2024
K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration SetsZevex, Inc. May 17, 2024
K240935 — ARENAL Anterior Cervical Plate SystemEffortmed, LLC May 17, 2024
K220891 — Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. May 17, 2024
K240482 — Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd. May 17, 2024
K233933 — CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc. May 17, 2024
K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC May 17, 2024
K233215 — icotec Anterior Cervical Plate SystemIcotec AG May 17, 2024
K232525 — Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. May 17, 2024
K241175 — MiRus MoRe Lumbar Plating SystemMiRus, LLC May 17, 2024
DEN230035 — DentalMonitoringDental Monitoring Sas May 17, 2024
K233209 — uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. May 17, 2024
K232516 — Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG May 17, 2024
K233236 — Radiance V5Gmv Soluciones Globales Internet S.A.U. May 17, 2024
K232786 — Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc. May 16, 2024
K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)Reshape Lifesciences May 16, 2024
K233841 — HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd. May 16, 2024
K232933 — AirKEE P900Healkee Medical Pte, Ltd. May 16, 2024
K233473 — DEKA LOTUSEl.En S.P.A. May 16, 2024
K233625 — RAYDENT SWRay Co., Ltd. May 16, 2024
K233137 — Ticare Dental Implant SystemsMozograu S.A. May 16, 2024
K232542 — Wedge XL Delivery CatheterMicroVention, Inc. May 16, 2024
K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc. May 16, 2024
K240752 — DEKA TOROEl.En S.P.A. May 16, 2024
K230711 — Pain Therapy Device(Model: P.T.S-X)Guangzhou Xinbo Electronic Co., Ltd. May 16, 2024
K240328 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Signifier Medical Technologies, Ltd. May 16, 2024
K240445 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.Thermo Fisher Scientific May 16, 2024
K240386 — Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd May 16, 2024
K240059 — FAgamin®Tedequim Srl May 16, 2024
K232495 — Sempulse Halo Vital Signs MonitorSempulse Corporation May 16, 2024
DEN230043 — Notal Vision Home Optical Coherence Tomography (OCT) SystemNotal Vision, Inc. May 15, 2024
K231940 — BruxZir® NOW SRCPrismatik Dentalcraft, Inc. May 15, 2024
K241049 — CANON Fundus Camera CR-10 (CR-10)Canon, Inc. May 15, 2024
K233247 — Heuron ICHHeuron Co., Ltd. May 15, 2024
K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery May 15, 2024
K240278 — Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. May 15, 2024
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