FDA 510(k) clearances — page 326
clearances on record, most recent first.
Clearances — page 326
32,501–32,600 of 175,699- K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
- K160196 — Fujifilm Video Colonoscope Model EC-600WL V2
- K160198 — UreTron MultiProbe Lithotripter System
- K160247 — 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
- K160326 — 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
- K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K153690 — PriMatrix Dermal Repair Scaffold
- DEN150009 — B.R.A.H.M.S PCT sensitive KRYPTOR
- K150492 — Ora-GUARD Dental Grind Guard
- K151263 — Venturi Gauze Wound Care Sets with Portal Drain
- K151423 — APEX Compounding System Transfer Set
- K151439 — ATLANTIS ISUS
- K151480 — Epix Electrosurgical Probe with Smoke Evacuation
- K151520 — Oscar 2
- K151793 — InMode RF System
- K152496 — CPX 4 Breast Tissue Expander
- K152611 — V20 system
- K152827 — Weely Manual Wheelchair
- K152922 — ViziShot FLEX
- K153215 — SmartBase for Arthrex Glenoid IRIS
- K153220 — syngo.CT Single Source Dual Energy (Twin Beam)
- K153330 — FreeStyle Precision Neo H Blood Glucose Monitoring System
- K153384 — Low Potassium Dextran Solution with Tris Diluent
- K153586 — Arthrex iBalance TKA System
- K160096 — InZone Detachment System
- K160315 — I4 (Integrated Intelligent Imaging Informatics) system
- K143290 — DBSWIN and VistaEasy Imaging Software
- K151258 — Arm automatic blood pressure monitor
- K151474 — Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
- K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
- K151945 — Triumph Resin Dam
- K152136 — Recovery Cone Removal System
- K152196 — Erchonia EVRL
- K152648 — Ennova Self-adhesive Electrode
- K152702 — ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
- K152902 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
- K153216 — Alpine Cemented Hip System
- K153247 — Fusion Compact Navigation System
- K153395 — OS2-C Compression Staple
- K153442 — CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
- K160291 — Optimus ALIF System
- K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
- K152422 — FREND Free T4 Test System
- K153095 — ROP Resorbable Hemostasis Material
- K153224 — VitalStim(R) Plus Electrotherapy System
- K153593 — CliniscanSM MRI
- K160113 — ST AIA-PACK hsE2 Calibrator Set
- K150157 — AnapnoGuard 100 Respiratory Guard System
- K151580 — D.N.E. External Fixation System
- K152343 — Direct Bilirubin
- K152485 — FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
- K153368 — Radiance V3
- K153370 — Caspian OCT/MESA Mini/DENALI Mini Spinal System
- K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- K153523 — FUSION Vascular Graft
- K153631 — Zimmer Virage OCT Spinal Fixation System
- K153647 — TSolution One w/ACG+ Surgical System
- K152596 — Intact® Gen2 System
- K153081 — Clear Bi-Light
- K151512 — Star 60
- K150277 — Pain Therapy System, Model PTS-II
- K150487 — X-Suit NIR Biliary Metallic Stent
- K151404 — ProTrach Dualcare
- K151429 — QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
- K151569 — Tranberg CLS Laser Fiber
- K151644 — Masimo Root Vital Signs Monitoring System and Accessories
- K151680 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K152187 — MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
- K152231 — Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
- K152781 — Adena-Zina System
- K153004 — Clear Guide SCENERGY
- K153077 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K153103 — CARESTREAM Vue PACS
- K153218 — Arthrex Synergy UHD4 System
- K153246 — PTFE Super Sheath Introducer 2.1
- K153307 — HS SutureTape
- K153309 — BD Vacutainer UltraTouch Push Button Blood Collection Set
- K153341 — Relieva Scout Multi-Sinus Dilation System
- K153543 — WHILL Model M
- K153608 — Vitoss BiModal Bone Graft Substitute Foam Strip
- K153625 — Single Use Injector NM600/610
- K153718 — Spirit Hair Removal laser Family
- K160001 — TraumaCad Mobile Release 2.0
- K160092 — Digital Electrocardiograph
- K151529 — Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
- K151918 — Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
- K152185 — ARCHITECT SHBG
- K152555 — Dental Implant System
- K152568 — C-VBR
- K152991 — OptoWire Deux
- K153080 — RTVue XR OCT Avanti with AngioVue Software
- K153605 — ivWatch Model 400
- K150826 — Nutra Face Lift Model PE8050
- K151311 — Safe Block Pen Needle
- K151553 — Anterior Cervical Plate System
- K153144 — TIO-H DIGITAL RADIOGRAPHY SENSOR
- K153232 — Cios Select
- K153589 — CD HORIZON Spinal System
- K151237 — Nutrisafe 2- ENFit Adaptor
- K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.