FDA 510(k) clearances — page 293
clearances on record, most recent first.
Clearances — page 293
29,201–29,300 of 176,542- K170249 — GRAVITY Syndesmosis LP
- K170372 — SpiralTech Dental Implant System
- K170794 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
- K171284 — FIBERGRAFT BG Matrix Bone Graft Substitute
- K171586 — Smart External Drain (SED) System
- K171612 — ACUITY Pro Lead Delivery System
- K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- K171680 — Infinity-Lock 3, Infinity-Lock 5
- DEN160047 — ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
- K161710 — SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL
- K162822 — ADAMS A1c HA-8180V, CALIBRATOR 80
- K163011 — PHA S1 Spinal System
- K163212 — Parietene DS Composite Mesh
- K163397 — SMR Hybrid Glenoid System
- K163524 — Vessel Dilator
- K170684 — Firebow Wire Torque Assist Device
- K170896 — Admira Fusion x-base
- K170940 — Rickettsia Real-time PCR Assay
- K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
- K171533 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K163153 — Livia
- K170122 — Delta III Lithotripter
- K170213 — SupraSDRM Biodegradable Matrix Wound Dressing
- K170830 — Unison-C Anterior Cervical Fixation System
- K171239 — TULA Tube Delivery System
- K162874 — Cannulated Screws Neoortho
- K163216 — Pinpoint GT Needles
- K163432 — Stellar LEAP
- K170297 — Tranquil Interbody System
- K170708 — OWL RF INSULATED CANNULAE
- K170735 — Powder-Free Clear Vinyl Patient Examination Gloves
- K170817 — Halcyon
- K171163 — Contact Lens Case Round Glasses
- K171536 — RayStation
- K171590 — Distal Elbow Plating System
- K171794 — Smith & Nephew 25 Fluid Management System
- K162797 — SpringTMS
- K170045 — Swedge Pedicle Screw Fixation System
- K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
- K170444 — PROCOTYL® PRIME Acetabular Cup System
- K170568 — CardioLogs ECG Analysis Platform
- K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
- K170962 — NuVasive® CoRoent® Thoracolumbar System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.