FDA 510(k) clearances — page 335
clearances on record, most recent first.
Clearances — page 335
33,401–33,500 of 176,542- 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
- K151635 — CapsoCam (SV-1)
- K151772 — Actreen Mini Intermittent Urinary Catheters
- K152271 — Powder Free Nitrile Patient Examination Gloves, Black color
- K152278 — ENDOFLOW II - Irrigation, Warming and Suction System
- K152297 — OBS Anchorage Screw
- K152476 — Exofin High Viscosity Tissue Adhesive
- K152645 — Dictum Health
- K152739 — Electronic Thermometer
- K152898 — DIODE LASER THERAPY SYSTEMS
- K153066 — BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
- K153340 — Epic Extremity Plate System
- K151475 — EndoChoice Select Injection Needle
- K152743 — M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
- K152868 — ExpressBraid Graft Manipulation
- K160068 — FilmArray Respiratory Panel (RP) for use with FilmArray Torch
- K143596 — MINIARS SCREWS
- K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
- K151185 — AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
- K151835 — Vital Signs Patch System
- K151955 — YuGo System
- K152168 — Love Liquid Personal Lubricant
- K152427 — PC ECG
- K152819 — Amecath Peripheral inserted Central Venous Catheter Sets
- K153028 — Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
- K153054 — N5-1
- K153173 — MOR Implant System
- K153489 — Cryocare CS Surgical System
- K153508 — Stryker CMF MEDPOR Customized Implant
- K153530 — Bridge Occlusion Balloon
- K151274 — Dr's Finder
- K152127 — CorMatrix Tyke
- K152237 — The Entasis Dual-Lead Sacroiliac Implant
- K152489 — ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
- K152529 — NaturaLase CO2 Laser System
- K152587 — DermaScalp Laser Cap
- K152948 — Medline Anti-Fog Solution
- K153082 — Rampart A Lumbar Interbody Fusion Device
- K153141 — DyeVert Contrast Modulation System
- K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
- K151912 — AIR-FLOW handy 3.0 PLUS
- K152878 — SUNTEC Mechanical Wheelchair, model ST-WL-1000
- K152994 — Adaptivo
- K153203 — Navigation Instruments
- K153398 — Comprehensive SRS/Nexel Elbow
- K160108 — Synapse PACS
- K152410 — Top Fine Pen Needle
- K153059 — HF1202H PowerPlus Portable X-ray Equipment
- K153211 — M-Fix Acromioclavicular Device
- K153416 — ArcScan Insight 100
- K153529 — WS80A Diagnostic Ultrasound System
- K160014 — iHealth Track Blood Pressure Monitor
- K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
- K152324 — YAHUA Spinal System
- K152505 — C2 NerveMonitor System
- K153204 — In2Bones Kirschner wire
- K153304 — Hansen Medical Magellan Robotic Catheter eKit
- K153528 — PacEndo EDTA
Data sourced from openFDA. This site is unofficial and independent of the FDA.