FDA 510(k) clearances — page 344
clearances on record, most recent first.
Clearances — page 344
34,301–34,400 of 176,542- K150141 — Orthodontics Bracket
- K150203 — Medentika CAD/CAM Abutments
- K150323 — FEMTO LDV Z8 Surgical Laser
- K150606 — Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
- K150936 — SureClip
- K151336 — LightStim Professional 2-Panel Light
- K151593 — Cellvizio 100 Series System with Confocal Miniprobes
- K151600 — R-40 EEG Amplifier
- K151821 — ER-REBOA Catheter
- K152106 — Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
- K152371 — Vantage Titan 3T
- K152474 — Avitus Bone Harvester
- K152560 — Bard Snare Retrieval Kit
- K152677 — geko T-2 Neuromuscular Stimulator
- K152800 — illumigene Mycoplasma DNA Amplification Assay
- K150314 — Masimo MightySat Rx Fingertip Pulse Oximeter
- K150741 — TSolution One w/ACG surgical System
- K150902 — 330psi Extension Y-Line with Dual Check Valve
- K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
- K151578 — Carbamazepine Gen 4
- K151893 — P.R.O. CG Manual Wheelchair
- K151895 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K151911 — WorkMate Claris System, WorkMate Claris System Display Plus
- K152096 — DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
- K152180 — PEAK
- K152784 — Pacel Bipolar Pacing Catheters
- K142505 — ClearPoint System
- K150474 — NuVasive VuePoint II OCT System
- K150855 — H-MAX S Femoral Hip System
- K151415 — Oregon Scientific
- K151646 — ProTech Plus
- K151736 — Philips IntelliVue GuardianSoftware
- K151836 — NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
- K151938 — S4 Cervical Spinal and Occiput Systems
- K151942 — EVS 3643
- K152066 — Luminesse Anterior Zirconia AT
- K152261 — PICC Tip Positioning Aid
- K152693 — CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels
- K152694 — Diamondback 360 Peripheral Orbital Atherectomy System
- K152704 — iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
- K152709 — HI-TORQUE BALANCE
- K152726 — JOURNEY II XR Knee System
- K152763 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
- K152770 — ProBP 2400 Digital Blood Pressure Device
- K152788 — EOS System
- K152867 — MHI-TM2000 Linear Accelerator System, VERO, Imavis
- K150153 — Swiss Navy Premium Silicone Lubricant +2 more
- K150160 — Temple Touch Pro (TTP) Non-invasive temperature monitoring system
- K150308 — Palm TENS
- K151389 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
- K151674 — Ultraviolet Sun Tanning Lamp
- K151956 — Admira Fusion x-tra
- K152014 — MTS300 Multiple Tray Sterilization System
- K152574 — Navio
- K143617 — AquaC UNO H
- K150156 — Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
- K150232 — Radifocus Optitorque Angiographic Catheter
- K150804 — QBioScan
- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K152156 — Opticage Expandable Interbody Fusion Device
- K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
- K150918 — PASS OCT Spinal System
- K151347 — MIS Spine Frame Instrument Case
- K151479 — EV-820 OTC Pain Relief TENS
- K151565 — Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
- K151640 — ELTRAC 471
- K151648 — Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
- K151671 — Disposable Multistage Dilation Balloon Catheter
- K151844 — Rainbow Shade
- K152094 — GR40CW
- K152362 — Terumo SurGuard 3 Safety Hypodermic Needle
- K152663 — Bladeless Optical Obturators
- K152687 — Arm-Type Fully Automatic Digital Blood Pressure Monitor
- K150173 — Aerobika OPEP Devive with Manometer
- K150835 — LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
- K151300 — AVERT Contrast Modulation System
- K151466 — MrOpen
- K151988 — Visible Patient Suite
- K152005 — MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K152035 — iSnare system-Lariat
- K152453 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K152455 — Amendia Cervical Plate System
- K152633 — Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
- K152710 — HammerFiX Device
- K150396 — Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
- K150717 — Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
- K150788 — Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
- K151220 — Dunamis Interference Screw
- K151571 — Mini Needle
- K151724 — AngioDynamics Mariner Angiographic Catheters
- K151785 — Px HA PEEK IBF System
- K152275 — Pantheris System
- K152621 — OSS/Arcos IM Total Femur Rod
- K152668 — truFreeze System
- K140325 — Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System
- K143308 — GelPOINT Transvaginal Access Platform
- K150687 — DripAssist
- K150693 — PHIN-FX Cannulated Lag Screw System
- K152109 — HD-Camera HDC1000
- K152140 — Boa Endoscopic Valve
Data sourced from openFDA. This site is unofficial and independent of the FDA.