FDA 510(k) clearances — page 246
clearances on record, most recent first.
Clearances — page 246
24,501–24,600 of 176,542- K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183300 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
- K183301 — PRO-LITE Sterilization Tray
- K183643 — Clear Image Aligners
- K181215 — Infrared Thermometer
- K181737 — Raycell MK1
- K181864 — Polaris RF Ablation System
- K182025 — ClearUP Sinus Pain Relief
- K182199 — NFC-700 non-mydriatic auto fundus camera
- K182855 — ProKnow DS
- K183352 — Optimus Neuro System
- K183476 — 3M Filtek Universal Restorative
- K183542 — Signature Orthodontic System
- K183101 — Zenition 50
- K183000 — ViperCath XC Peripheral Exchange Catheter
- DEN170091 — EyeBOX
- K180204 — CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- K180867 — AmCAD-UO
- K181703 — Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
- K182736 — OIC Suture Anchor System
- K183369 — COR12 ECG
- K182045 — Lotus III Multi-Pulsed Er: Yag Laser System
- K182130 — iSchemaView RAPID
- K182404 — STERRAD VELOCITY Biological Indicator
- K182461 — LATITUDE EV Total Elbow Arthroplasty
- K182564 — Quantib ND
- K182845 — minisono
- K183169 — Pulse 2.0, Pulse Pro 2.0
- K181761 — Zimmer Biomet Select Ceramic Heads
- K182099 — Delta TT Pro
- K182242 — VO200 NeurOs Cerebral Oximetry System
- K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
- K182709 — One-Step Suprapubic Introducer
- K182783 — DePuy Synthes Trauma Orthopedic Nail Implants
- K181641 — QuikClot Radial
- K183007 — EliA SmDP Immunoassay
- DEN170070 — MLL (KMT2A) Breakapart FISH Probe Kit +4 more
- DEN180007 — Miris Human Milk Analyzer
- K173036 — North-vision Multi-parameter Patient Monitor
- K173747 — REXLENE
- K180014 — Creme de La Femme Feminine Lubricant
- K180380 — vital signs monitor
- K180821 — TruMatch Graft Cage - Long Bone
- K180826 — Natrelle 133 Plus MICROCELL Tissue Expander
- K181037 — DIO CAD/CAM Abutment
- K181120 — 2.8 mm/3.3 mm PopLok Suture Anchors
- K181331 — JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
- K181412 — VITEK MS
- K181555 — Arthrex Fracture Adapter Hemi Shoulder Prosthesis
- K181690 — Clear-Jet Injection Catheter
- K181752 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K182032 — SterilContainer S System
- K182167 — The ICHOR Panacea Vascular Embolectomy Catheter System
- K182682 — OrthoGold 100
- K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
- K182750 — 4D View
- K182755 — Disposable Temperature Probe
- K182776 — Neocis Guidance System
- K182781 — PTS Professional Chemistry Kit
- K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K183012 — vascuCAP
- K183059 — 3nethra neo
- K183068 — Nitrile Glove Powder Free White
- K183328 — Pulse Rx 2.0, Pulse Pro Rx 2.0
- DEN170021 — SEM Scanner (Model 200)
- DEN170072 — Enlight 1810
- K162553 — AirSpiral Heated Breathing Tube
- K173041 — 3DIEMME RealGUIDE
- K180828 — Natureplex Warm Touch Warming Jelly
- K180830 — Reuter Tip Deflecting Wire Guide
- K181589 — Curiteva Lumbar Interbody Fusion System
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K181838 — Sinusway Dilation System
- K181861 — Embrace
- K182165 — Color Doppler Ultrasound System; Model: mEye1 and mEye2
- K182320 — BD Contoured Base Pen Needle
- K182420 — ASAHI Corsair Pro XS
- K182454 — O2 Concepts Oxlife Independence Model 301-0001
- K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
- K182972 — Phoenix Atherectomy System
- K183036 — Dilator Sets
- K183115 — MTS Levofloxacin 0.002 - 32 µg/mL
- K183123 — microTargeting Guideline 4000 5.0 System
- K183267 — DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System
- K173140 — VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
- K180846 — Arterial Pressure Monitoring Set/Tray
- K180863 — FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
- K181785 — Modified BrainScope One
- K182116 — BA310 Abutment, BIA310 Implant/Abutment
- K182149 — FFRangio System
- K182190 — Fetal Doppler
- K182446 — TruShot with Y-Knot All-Suture Anchor
- K182610 — Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
- K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K183239 — CoreLink F3D Lateral System
- K180909 — REVEL Spacers
- K181087 — Apex Locator, DPEX III
- K181496 — VINTAGE PRO
- K181756 — Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.