FDA 510(k) clearances — page 327
clearances on record, most recent first.
Clearances — page 327
32,601–32,700 of 175,699- 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
- K160044 — Image1 SPIES System
- K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
- K153628 — ROSC-U Mini Chest Compressor (RMCC)
- K142664 — URight Hemoglobin A1c system, FORA A1c System
- K150893 — IntelliCuff
- K151194 — KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
- K151426 — ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
- K151735 — TriMed Humeral Supracondylar Fixation System
- K151939 — COALITION Spacers
- K152247 — ATLANTIS Crown
- K152915 — EYE-SYNC
- K153157 — Sonendo Gentle Wave System
- K153169 — PASS OCT Patient Specific Rods
- K153428 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
- K153475 — SD5 & SD6 Ultrasonic Tabletop Doppler
- K151436 — PICO Single Use Negative Pressure Wound Therapy System
- K151716 — Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
- K152188 — QUAD Dental Implants and Prostheses
- K152344 — Total Bilirubin
- K152512 — Half Dome Posterior Lumbar Interbody System
- K153129 — dynaMX Tabbed Staple
- K153186 — Adjustable Fixation Device
- K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
- K153459 — TACVAC
- K153525 — Seneka II Polyscrew Pedicle Fixation System
- K153686 — SPIWay Endonasal Access Guide
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150672 — VistaCam iX Proof
- K151354 — Cervello STIM
- K151367 — Sydney IVF Hyaluronidase
- K151787 — Holter System
- K152233 — BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
- K152986 — StatStrip Xpress 2 Glucose Hospital Meter System
- K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
- K153500 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
- K153729 — 8F FlowGate2 Balloon Guide Catheter
- K143615 — Antistatic Compact Space Chamber
- K150498 — Discovery 24
- K151259 — Sysmex Automated Blood Coagulation Analyzer CS-2100i
- K151405 — Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
- K151701 — Tenodesis screw system
- K151812 — PATIENT MONITORS VARIOUS MODELS
- K152456 — CenterCross Ultra Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.