510(k) Clearances — Page 179

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 179 of 3,525)
ClearancesDetails
K232984 — Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. Dec 18, 2023
K231929 — iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd. Dec 18, 2023
K222846 — AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. Dec 18, 2023
K232780 — CC-Clip® Implant SystemCc-Instruments, Inc. Dec 18, 2023
K232847 — SiOxD Wound MatrixSioxmed, LLC Dec 18, 2023
K231429 — S-Plant Dental Implant SystemIdis Co., Ltd. Dec 18, 2023
K222881 — Access hsTnIBeckman Coulter, Inc. Dec 18, 2023
K233815 — ClotTriever SheathInari Medical, Inc. Dec 18, 2023
K233691 — FlexCath Cross Transseptal SolutionAcutus Medical, Inc. Dec 17, 2023
K233536 — Air Compression Recovery SystemShenzhen Dongjilian Medical Tech Co., Ltd. Dec 16, 2023
K232095 — SeptiCyte RAPIDImmunexpress, Inc. Dec 15, 2023
K230926 — Ova+ (K-OVAP-USA)Tenscare, Ltd. Dec 15, 2023
K231447 — Double Internal Joint Stabilizer- ElbowSkeletal Dynamics, Inc. Dec 15, 2023
K233607 — MagnetOs Easypack PuttyKuros Biosciences B.V Dec 15, 2023
K232394 — Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus And Instruments Co., Ltd. Dec 15, 2023
K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services And Savings, Inc. Dec 15, 2023
K232939 — IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd. Dec 15, 2023
K232887 — Invisalign Palatal Expander SystemAlign Technology, Inc. Dec 15, 2023
K233681 — ConFirm 20 Minute IncubatorSTERIS Corporation Dec 15, 2023
K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company) Dec 15, 2023
K232384 — Videa Dental AssistVideahealth, Inc. Dec 15, 2023
K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation Dec 15, 2023
K231478 — Digital Blood Pressure Monitor (Model: YB-800)Wenzhou Yosun Medical Technology Co.,Ltd Dec 15, 2023
K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)Eximo Medical, Ltd. Dec 15, 2023
K231700 — Ziehm Vision FDZiehm Imaging GmbH Dec 15, 2023
K230949 — ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. Dec 15, 2023
K231825 — Panther TPSProwess, Inc. Dec 15, 2023
K232892 — Hp Detect™ Stool Antigen ELISABiomerica, Inc. Dec 15, 2023
K231160 — Cardio Q50, Cardio Q70Bionet Co., Ltd. Dec 15, 2023
K232267 — Precice Max SystemNuvasive Specialized Orthopedics, Incorporated Dec 15, 2023
K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)Zibo Kaiyue Mould Technology Co., Ltd. Dec 15, 2023
K230751 — EW10-EC02 Endoscopy Support ProgramFujifilm Corporation Dec 15, 2023
K232598 — Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. Dec 15, 2023
K223721 — Masimo StorkMasimo Corporation Dec 15, 2023
K230501 — Spirobank OxiMir Medical International Research USA Dec 15, 2023
K233237 — xeo+ FamilyCutera, Inc. Dec 15, 2023
DEN230050 — Body Temperature Software (BTS)Fitbit, LLC Dec 15, 2023
K232957 — Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd. Dec 15, 2023
K231721 — Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd. Dec 14, 2023
K233670 — Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. Dec 14, 2023
K231801 — MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited Dec 14, 2023
K223470 — C50Sopro Dec 14, 2023
K232580 — Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. Dec 14, 2023
K232283 — PhySoftAMS®Physician Software Systems, LLC Dec 14, 2023
K230950 — ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc. Dec 14, 2023
K231570 — StrokeViewer PerfusionNico-Lab B.V. Dec 14, 2023
K231645 — PherDal® At-Home Insemination KitPherdal Fertility Science, Inc. Dec 14, 2023
K232875 — Vial Adapter 20mmWest Pharma. Services IL, Ltd. Dec 14, 2023
K233374 — Secret ProIlooda Co,., Ltd. Dec 14, 2023
K231181 — bright CTDentium Co., Ltd (Ict Branch) Dec 14, 2023
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