FDA 510(k) clearances — page 334
clearances on record, most recent first.
Clearances — page 334
33,301–33,400 of 176,542- K160392 — Novilase Laser Therapy System, Model LTS-2
- K151406 — Cogent Lateral Interbody System
- K151435 — MRCAT
- K151508 — IRENE Locking Compression Plate System
- K151737 — MedicVOD System
- K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic)
- K152141 — High Pressure Tanning Lamps
- K152332 — Perfectio LED infrared device
- K152438 — ETView VivaSight-SL (TVT) system
- K152593 — LATEX EXAMINATION GLOVE POWDER FREE
- K152691 — EDS Universal Cement
- K152715 — HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K152736 — SKIN CARE
- K152989 — Mammotome revolve Dual Vacuum Assist Biopsy System
- K153091 — IMPLANT 3D
- K153135 — VITAL SIGNS MONITOR
- K153443 — ASAHI Astato XS 40
- K153488 — Occlusion Perfusion Catheter
- K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200
- K153617 — OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
- K153677 — The Cellfina System
- K153759 — SIGN Compression Screw System
- K160063 — McLaren Proton Therapy System
- K160164 — BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- K160184 — Voluson S6, Voluson S8, Voluson S10
- K160328 — DIVA ZSP2105CMI with QUBYX PerfectLum bundle
- K150304 — Oxyless Blood Tubing Set
- K151337 — Strialite
- K152085 — Liquid CO2-2 (LCO2-2)
- K152088 — IV-eye
- K152310 — HeartLight Deflectable Sheath
- K152539 — SpineView X-Pac Expandable Lumbar Cage System
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
- K153588 — EndoChoice Water Bottle Cap System
- K160161 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K142969 — ANI Monitor
- K151092 — Arthrex Short Suture Anchors
- K151717 — twion
- K152034 — FS-PACS
- K152160 — Navik 3D
- K152557 — Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
- K152831 — Spot Skan
- K153323 — Palisade Pedicular Fixation System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.