FDA 510(k) clearances — page 53
clearances on record, most recent first.
Clearances — page 53
5,201–5,300 of 175,620- K243641 — da Vinci Surgical System (IS5000)
- K242124 — Sim&Size
- K231424 — HeartBeam AIMIGo(TM) System
- K233001 — Bioscope Neuromonitor Device
- K233486 — 731 Series Ventilator
- K240778 — Vivo 1, Vivo 2
- K240779 — Vivo 3
- K240924 — Anterion
- K240998 — ABL90 FLEX PLUS System
- K241160 — CAIs Sensor (CAIs-001)
- K241998 — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
- K242463 — ARIA Radiation Therapy Management System (18.1)
- K242487 — Laminar P1 (LDH-HW-001)
- K242532 — BTL-785BNF-E
- K242668 — Gastro Concepts Air Assist
- K243196 — Uro-G HD Cystoscope (1520)
- K243281 — LOCK-IN Spinal Fixation System
- K243307 — LCD Monitor (MDEC-2523)
- K243493 — Agilis NxT Steerable Introducer Dual-Reach
- K243560 — Remex Spine Surgery Navigation Instrument
- K243635 — aprevo® anterior lumbar interbody fusion device with interfixation
- K233152 — GENIOVA aligners
- K240735 — visio.lign color, visio.lign shield
- K241253 — Medicon Epiplating System
- K241271 — Aqua Medical RF Vapor Ablation System
- K241389 — Infrascanner Model 2500 (Model 2500)
- K242020 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
- K242832 — NExT Station; NExT Station Advanced
- K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
- K243495 — Natus Ultrapro S100 (982A0594)
- K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K240758 — Radiofrequency Generator System, Cura RF Electrode
- K241045 — Disposable Subdermal Needle Electrode, Corkscrew
- K241088 — EndoTool IV (3.1)
- K241219 — FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
- K241873 — OsseoFit Stemless Shoulder System
- K242033 — Access25 Delivery Microcatheter
- K242263 — TECHFIT DISRP® System
- K242378 — Eclipse Treatment Planning System (18.1)
- K242417 — VECTR Video Endoscopic Carpal Tunnel Release System
- K242747 — FAQ (302)
- K243369 — Cervical Plating System
- K243491 — SternalPlate Expansion
- K243498 — Alinity c Benzodiazepines Reagent Kit
- K243548 — BriefCase-Triage
- K231216 — POTENZA
- K241391 — Straumann® PURE Ceramic Implants
- K241505 — DRX-Revolution Mobile X-ray System
- K241521 — Prelude Small O.D. Introducer Guide Wire
- K242025 — Elos Accurate® Hybrid Base
- K242327 — Empulse M90
- K242461 — IRISeg
- K242511 — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
- K242630 — Aerin Console
- K242848 — Philips IntelliSite Pathology Solution 5.1
- K243132 — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)
- K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
- K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
- K240841 — Digital Radiography System (ManntiX B, ManntiX K)
- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
- K242508 — Verily Numetric Retinal Camera
- K242729 — AutoContour (Model RADAC V4)
- K242758 — Atrauman® Ag
- K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail
- K240700 — HomeSleepTest (HST, HST REM+)
- K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories
- K240561 — Rugged Oxygen Generator (ROG) (RO01-00001)
- K240680 — CDM Insights
- K240840 — Oxygen Concentrator (ZY-10AB/115)
- K240926 — PeekMed web
- K240971 — 87 NeuGlide Catheter
- K241073 — DZ-Tabone Intervertebral Body Fusion Device
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K241260 — ACTIFY Unicondylar Knee System
- K241543 — DrAid for Liver Segmentation
- K241567 — MC2 Portable X-ray System
- K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
- K241923 — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
- K241946 — PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-
- K241989 — Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
- K242304 — RED
- K242524 — SyMRI
- K242645 — INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
- K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
- K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
- K242824 — PTFE Guidewire
- K242950 — WallFlex Biliary PLUS RX Stent System
- K243073 — AnyPlus Navigated Instruments System
- K243486 — SmartSiteTM Vented Vial Access Device
- DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- K241128 — TDM Plate and Screw System
- K241674 — OSTEOPAL® V
- K242525 — iTOF®
- K242653 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL
- K242703 — LW Pre-milled Abutment
- K242740 — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
- K243435 — Magnetic Localization Patch Kit (AFR-00021)
Data sourced from openFDA. This site is unofficial and independent of the FDA.