FDA 510(k) clearances — page 291
clearances on record, most recent first.
Clearances — page 291
29,001–29,100 of 175,699- K162154 — Pantheon Medical Balanced Plating System
- K162441 — PowerPICC Provena Catheters with SOLO Valve Technology
- K162748 — MindMotionPRO
- K163650 — ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
- K170012 — Foot and Hand Motion
- K170536 — ECG Disposable Lead Wire
- K170858 — FDR AQRO (DR-XD 1000)
- K170887 — EVOS Small Fragment Plating System
- K160179 — VivaChek Ino Blood Glucose Monitoring System
- K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System
- K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)
- K162294 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K162655 — StealthConnect Remote Viewing, Planning and Collaboration System
- K162930 — Aero Chrome* Select Breathable Performance Surgical Gowns
- K163088 — TSIII BA Fixture
- K163255 — CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor
- K163516 — Braun No Touch + Forehead NTF3000 Thermometer
- K163537 — Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
- K163645 — DERMABOND PRINEO Skin Closure System
- K170221 — syngo.CT Cardiac Planning
- K170358 — joimax Endovapor 2
- K170537 — Nexxis OR, Nexxis
- K170716 — PercuNav Image Fusion and Interventional Navigation
- K170721 — Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
- K170865 — EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
- K170869 — LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
- K170953 — Tomcat Cervical Spinal System
- K152830 — K3
- K161910 — Cardinal Health Sterilization Wrap
- K162017 — Ross Ru Wound Dressing Gel
- K162151 — PENTAX Medical ENT Video Imaging System
- K162236 — Ax Stand-Alone ALIF System
- K162354 — Sniper Staple System
- K162607 — BeneVision Central Monitoring System
- K162722 — HyperSense
- K162901 — Penumbra 3D Revascularization Device
- K163160 — Sterile Single-use Infusion Set
- K163235 — HEM-9210T
- K163415 — SlimShape System
- K163677 — Ortho System
- K163690 — DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
- K163708 — QiF Blood and Fluid Warmer
- K160502 — TEG 6s Hemostasis System
- K160680 — VisioFocus Mini, VisioFocus Smart
- K161884 — Ortho System
- K163383 — GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
- K170052 — Stellaris Elite vision enhancement system
- K170215 — LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
- K160967 — Finapres Nova Noninvasive Hemodynamic Monitor
- K162087 — NovoGro
- K162296 — OmniPod Insulin Management System
- K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- K163387 — PICO Single Use Negative Pressure Wound Therapy System
- K163523 — ECHELON CIRCULAR Powered Stapler
- K170120 — EndoRotor
- K170247 — Lacriflow CL
- K170406 — Plato MICROCATH 27B Microcatheter
- K170533 — Model 330 Multifunction Aspirator
- K170593 — Mako Total Hip Application
- K162108 — Pressio 2 ICP Monitoring System
- K162361 — Soft Plug Extended Duration 180 Canalicular Plug
- K162621 — Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
- K163001 — PowerFlow Apheresis I.V. Port
- K163484 — Paxman Scalp Cooler
- K170833 — EndoFLIP® System with FLIP Topography module
- DEN150048 — gammaCore Non-invasive Vagus Nerve Stimulator
- K161741 — GMK UNI
- K161743 — Etgar Dental Implant System
- K161794 — CENTURION Vision System (Active SentryTM)
- K162382 — Smart Dongle Blood Glucose Monitoring System
- K162438 — Sofia Influenza A+B FIA on Sofia 2
- K162517 — Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
- K162636 — Marco Ultra M3, Marco Ultra M4
- K162785 — Velox Nebulizer System
- K162891 — Complete Control System
- K163171 — CeraClean
- K163329 — Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
- K163381 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
- K163581 — Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
- K163656 — Hoffmann LRF System
- K170251 — Threshold Pedicular Fixation System
- K170255 — Threshold V2 Pedicular Fixation System
- K170266 — Palisade Pedicular Fixation System
- K170268 — Fortress Pedicular Fixation System
- K170582 — Saf-T-Vac Smoke and Fluid Evacuator
- K170643 — Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
- K161179 — Intelli-Ox
- K162353 — MICATM Screw System
- K162447 — PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
- K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
- K163443 — Interson USB Ultrasound System
- K163461 — Coolief* Cooled RF Probe
- K170055 — CAPRI Corpectomy Cage System
- K170214 — Additive Orthopaedics Locking Lattice Plate
- K170502 — Patient Positioning System
- K170610 — PlasmaBlade T
- DEN160056 — Philips IntelliSite Pathology Solution
- K161114 — HIGH V+
- K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
- K170386 — BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.