FDA 510(k) clearances — page 300
clearances on record, most recent first.
Clearances — page 300
29,901–30,000 of 176,542- 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
- K160990 — Nova Max Uric Acid Monitoring System
- K162046 — MINNE TIES MMF Suture System
- K163021 — HAAG-STREIT FUNDUS MODULE 300
- K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
- K163617 — REMbrandt
- K163698 — OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
- K170445 — LOGIQ S8
- K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution
- K170580 — Carestream Vue PACS
- K170788 — CyberKnife Treatment Delivery System
- K162068 — ARROW Anatomical Porous glenoid
- K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- K162968 — VORTRAN GO2VENT
- K163125 — geko T-2 and geko Plus R-2 Neuromuscular Stimulators
- K163192 — Comfort EC710
- K163271 — i-Stat Alinity System with i-Stat Glucose test
- K163386 — Keos Lumbar IBFD
- K152192 — LED Curing Light
- K160549 — MEDICAL DIODE LASER SYSTEMS
- K160694 — Disposable Endotracheal tube, sterile, AccuCuff
- K162838 — Philips iCT CT System
- K162877 — VOCSN Unified Respiratory System
- K163144 — gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
- K163265 — Kepler II
- K163361 — ANTHEM Fracture System
- K163372 — RX Takeru Balloon Dilatation Catheter
- K170059 — Spectranetics Turbo-Elite Laser Atherectomy Catheters
- K170598 — ZeroWire Mobile
- K170724 — NeuroBlate System
- K170813 — ORTHOPANTOMOGRAPH OP 3D
- DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
- K153763 — Howell Biliary Aspiration Needle
- K160323 — FlowKeepers
- K161599 — UNO Negative Pressure Wound Therapy System
- K161829 — Huvitz Imaging System
- K162203 — POGO Automatic Blood Glucose Monitoring System
- K162287 — Synapse 3D Perfusion Analysis
- K162488 — Optiflux dialyzer
- K162617 — NobleStitch EL
- K162925 — AcQGuide Steerable Sheath
- K162927 — PRECICE UNYTE CoCr System
- K163101 — CEDIA Buprenorphine II Assay +3 more
- K163220 — Atellica CH Phencyclidine (Pcp)
- K163233 — MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
- K163246 — Leva Anterior Expandable Spacer System
- K163256 — Dual Mode Infrared Thermometer
- K163469 — ViziShot 2 FLEX
- K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
- K170171 — IOLMaster 700
- K170385 — CORE M2 Vascular System
- K170700 — Inqwire Diagnostic Guide Wire
- K161332 — NILE Proximal Fixation Spinal System
- K161341 — LIFESYS PACS
- K161712 — Arm automatic blood pressure monitor
- K161919 — UltraScan 650
- K161982 — C-Reactive Protein Kit for use on SPAPLUS
- K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Data sourced from openFDA. This site is unofficial and independent of the FDA.