FDA 510(k) clearances — page 285
clearances on record, most recent first.
Clearances — page 285
28,401–28,500 of 175,699- K153138 — Cerdak Basic
- K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
- K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
- K162821 — Babyleo TN500
- K162897 — Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
- K162993 — Gemini Sterilization Wrap
- K163437 — hypodermic Pinpoint GT Needle
- K163449 — HyPHo Laser System
- K163668 — SUITESTENSA
- K170094 — POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
- K170270 — Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
- K170302 — YELLOW LASER PHOTOCOAGULATOR YLC-500
- K170620 — ReBOSSIS85
- K170759 — CRE Pulmonary Balloon Dilatation Catheter
- K171009 — LASEMD Laser System
- K171146 — Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
- K171188 — Ossler Exam Scope
- K171324 — Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
- K160899 — CoVa Monitoring System 2
- K162299 — Spiral Shape Dental Implant System
- K162723 — TransFix/EDTA Vacuum Blood Collection Tubes
- K163316 — Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
- K163399 — Tria Firm Ureteral Stent
- K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
- K170299 — Ion PGM Dx System
- K170629 — VITRUVIAN INFILTRATION PUMP
- K170727 — VariAx 2 Compression Plating System
- K170883 — FilmArray NGDS Warrior Panel
- K170922 — Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
- K170933 — Merit Hydrophilic Guide Wire
- K171047 — Sterile Polyisoprene Powder Free Surgical Gloves
- K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
- K171591 — CUBEScan BioCon-900 (Bladder Volume Measurement System)
- K171606 — AOS Anterolateral Proximal Humeral Plate
- DEN160040 — Embosphere Microspheres
- K161808 — Solution Set with 1.2 Micron Air Eliminating Filter
- K162737 — VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
- K163049 — GOLNIT Non-Absorbable PTFE Surgical Suture
- K163104 — Terrace Anterior Cervical Plate System
- K163195 — PRIMUS
- K163345 — TVC Imaging System, TVC Catheter
- K170016 — Biodesign Fistula Plug
- K170551 — ImPACT Quick Test
- K170638 — Retina Workplace
- K170714 — Venue
- K170755 — DRX-Revolution Nano Mobile X-ray System
- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K171485 — BSD4343R Digital Flat Panel X-ray Detector
- K162515 — COSMED K5 Wearable Metabolic Technology
- K162942 — Corin MetaFix Hip Stem
- K163447 — Premium Plus Disposable Barrier Sleeve
- K163494 — Summit Spine Channel Cervical Interbody Fusion System
- K163593 — Additive Orthopaedics Bunion System
- K170039 — STERRAD VELOCITY Biological Indictator and Reader
- K170418 — Stryker SonicPin System
- K170571 — Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
- K170918 — Compex Sport Elite
- K162588 — Möller Medical Biopsy Needles and Systems
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- K162886 — DEKA MOTUS AX
- K163029 — Hydris Oral Rinse
- K163506 — Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
- K170669 — Insulia Diabetes Management Companion
- K170693 — Phantom Small Bone Intramedullary Nail System
- K170893 — Materialise Glenoid Positioning System
- K170903 — Compex Wireless USA
- K161533 — A1C EZ Glycohemoglobin Analysis System
- K161582 — DORA Tubing Sets for Hemodialysis
- K162215 — Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
- K162659 — Diode Laser Hair Removal System
- K162674 — BioPro Foot Plating Systems
- K163676 — Silhouette InstaLift
- K170066 — Green16/Green18 (Model: PHT-65LHS)
- K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
- K170474 — Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
- K170843 — Alians Fragment Specific
- K170909 — Infinix INFX-8000V, V6.40
- K171223 — Quantum TTC Biliary Balloon Dilator
- K171481 — MagVita TMS Therapy System
- K171538 — Cure Lumbar Plate System
- K161177 — Axiom PX
- K162459 — AccuPoint Electrode
- K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay
- K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
- K162826 — Encore Neutral
- K163084 — Merit Coronary Control Syringe
- K163632 — Katalyst Cyclophotocoagulation Probe
- K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
- K170263 — AcuNav Diagnostic Ultrasound Catheter 8F,10F
- K170288 — BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
- K170499 — sensiLift
- K170569 — SeaSpine Shoreline ACS - Anterior Cervical Standalone System
- K170803 — HydroMARK Breast Biopsy Site Markers
- K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing
- K170849 — SIMPLANT Guide
- K170850 — Alma Q
- K170992 — AcuNav V 10F Ultrasound Catheter
- K171494 — TroClose1200, TroClose1200 Cannula
- K160890 — Howell Biliary Introducer Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.