FDA 510(k) clearances — page 80
clearances on record, most recent first.
Clearances — page 80
7,901–8,000 of 176,479- K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
- K233620 — MIM - Centiloid Scaling
- K240474 — Multi-function Platform Systems (BL-M10)
- K240511 — Dentis s-Clean SQ-SL Fixture
- K240520 — Diode Laser Hair Removal System (SH-VD910)
- K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
- K241252 — Disposable Vinyl Examination Gloves
- K241276 — Vector Pedicle Screw System
- DEN230035 — DentalMonitoring
- K220891 — Kahook Dual Blade Glide (KDB Glide)
- K232516 — Sentec Digital Monitoring System (SDMS) tCOM+
- K232525 — Yoni.Fit Bladder Support
- K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- K233209 — uOmnispace.CT
- K233215 — icotec Anterior Cervical Plate System
- K233236 — Radiance V5
- K233933 — CIRRUS HD-OCT Model 6000
- K240482 — Intense Pulsed Light System (ST-690)
- K240935 — ARENAL Anterior Cervical Plate System
- K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- K241175 — MiRus MoRe Lumbar Plating System
- K230711 — Pain Therapy Device(Model: P.T.S-X)
- K232495 — Sempulse Halo Vital Signs Monitor
- K232542 — Wedge XL Delivery Catheter
- K232786 — Stimulation System (PA series, PR series, S series and Q series)
- K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- K232933 — AirKEE P900
- K233137 — Ticare Dental Implant Systems
- K233473 — DEKA LOTUS
- K233625 — RAYDENT SW
- K233841 — HD80 Series Ultrasound Diagnostic System
- K240059 — FAgamin®
- K240328 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- K240386 — Picosecond Nd:YAG Laser Systems (BL-C10)
- 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.
- K240752 — DEKA TORO
- K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040) +2 more
- DEN230043 — Notal Vision Home Optical Coherence Tomography (OCT) System
- K231940 — BruxZir® NOW SRC
- K233247 — Heuron ICH
- K233985 — TRIUX neo (NM27000N ); MEGreview (SW26241N-B)
- K240278 — Full Wedge Lateralized and Augmented Baseplates
- K240368 — E3D-A Interbody System
- K241043 — Augment Off-Axis Instrument System
- K241049 — CANON Fundus Camera CR-10 (CR-10)
- K241053 — MVR Venous Reservoir Bag 800 mL +3 more
- K241112 — BriefCase-Quantification
- K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire
- K233913 — Electric Breast Pump (8 models)
- K240426 — Aventus Clot Management System
- K232242 — BEAR 2 Body
- K232529 — Disposable Double Lumen Endobronchial Tube
- K232614 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
- K232862 — MIM Monte Carlo Dosimetry
- K233875 — Brainomix 360 e-Lung
- K240658 — 1060nm laser body slimming machine
- K240759 — REMEX-GR100
- K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) +5 more
- K232410 — SmartChest
- K232475 — Disposable infusion set with needle
- K232507 — Aerogen®Solo Nebulizer System
- K233100 — QIAstat-Dx® Respiratory Panel Plus
- K233277 — Filter Needle for Single Use
- K233629 — APERTO Lucent MRI System
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer
- K234079 — HyperSuture Extension Line
- K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- K240365 — Bioceramic Root Repair Material (C-Root BP)
- K240374 — Ureterorenoscope System
- K240479 — Access OV Monitor
- K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx
- K240699 — SCARLET® AC-Ti
- K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
- K232025 — Hushd Pro Avera
- K232468 — SC Medica FFX
- K232470 — Polyisoprene Extra Large Condom
- K232477 — Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
- K232976 — VUZE System
- K233418 — Biofourmis Everion+ (G2)
- K233602 — P200TE (A10700)
- K233918 — Dental Barrier and Sleeves
- K233967 — DePuy Synthes MatrixSTERNUM Fixation System
- K233982 — CEREGLIDE 92 Catheter System
- K234112 — Customized Abutment
- K240296 — Tulsa Pro System (Pad-105)
- K240403 — Access BR Monitor
- K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960)
- K222292 — F&P myAirvo 3
- K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K233803 — UltraClear Laser System (N/A)
- K240964 — FLOW 90? Wand
- K240999 — Legend X Applicator VO
- K241008 — Tricera Arthroscopic System +13 more
- K231612 — Eve Patient Positioner System
- K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable
- K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K232833 — HALO AP Dx
- K232928 — DeepContour (V1.0)
Data sourced from openFDA. This site is unofficial and independent of the FDA.