FDA 510(k) clearances — page 62
clearances on record, most recent first.
Clearances — page 62
6,101–6,200 of 176,479- 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 (4 models)
- K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
- K240706 — PowerCube+ Series (3 models)
- K240841 — Digital Radiography System (ManntiX B, ManntiX K)
- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more
- 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) +12 more
- 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) +3 more
- 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)
- K243444 — BIOCERAM AZUL® HEAD
- K243447 — Rapid Surgical Plan (RSP-SW-001)
- K243463 — BIOFIRE FILMARRAY Tropical Fever Panel
- K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
- K240671 — XBeam (v2)
- K241197 — DeepRhythmAI
- K242184 — Alcon 27GA Chandelier (8065000252) +2 more
- K242185 — Rextar Pro
- K242301 — Socrates 38 Catheter
- K242348 — Locking Screw,CoCrMo
- K242395 — Nanox.ARC
- K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K242685 — Atellica® CH Creatinine_3 (Crea3)
- K242686 — Neodent Implant System
- K242831 — Triathlon Knee System +7 more
- K243180 — SSPC NXT Delivery Catheter
- K243265 — Ion 3D
- K243417 — RelieVRx
- K243475 — Chemical Indicator for enspire CLCSPS (LCC015)
- K241486 — Sofsilk Coated Braided Silk Suture
- K242188 — ClearRead CT CAC
- K242861 — TrueLok Elevate
- K243454 — Verruca-Freeze H
- K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
- K243470 — Fix2Lock (PEEK Self Punching)
- K223120 — Ventoux VC2; Ventoux VC3
- K240475 — Hintermann Series H2 Total Ankle System
- K241871 — Philips IntelliSite Pathology Solution
- K242619 — GroWell BT Hair Growth System (GW10042)
- K243020 — MIDASVu
- K243232 — GripMate
- K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K241090 — Evie Med Ring
- K241628 — YO Home Sperm Test
- K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- K243375 — Ruthless Spine RJB
- K233273 — C&B Ceramic; C&B Permanent; C&B Interim
- K240645 — Sonix Health
- K240994 — Nexpowder
- K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.