FDA 510(k) clearances — page 312
clearances on record, most recent first.
Clearances — page 312
31,101–31,200 of 176,542- K162300 — Reform® POCT System
- K162316 — Pirouette 014
- K162355 — Raycast MammoRx Carbon Fibre Breast Board
- K162743 — ViewPoint 6
- K162970 — FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
- K162971 — Multix Fusion Max
- K160132 — Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
- K160508 — Electronic Pulse Stimulator
- K160656 — CorSens
- K160762 — Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- K160786 — RODO Abutment System
- K161457 — XEN Glaucoma Treatment System
- K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
- K161782 — Arthrex Univers Revers Shoulder Prosthesis System
- K161891 — HC Primer
- K161944 — Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
- K162024 — AltiVate Anatomic Shoulder System
- K162050 — ZELTIQ CoolSculpting System
- K162175 — Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
- K162220 — DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
- K163185 — OptiLux LED Illuminator
- K152232 — Quest Diagnostics HairCheck-DT (Cocaine)
- K153394 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
- K160558 — RAPIDO HOLLOW-FIBRE DIALYZERS
- K160595 — PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
- K160933 — Discovery NM 750b Bopsy
- K161472 — Walk-O2-Bout
- K161673 — LacriPro Punctum Plug
- K161795 — MAGNETOM ESSENZA
- K162078 — EVOS Small Fragment Plating System
- K162160 — Preference Elite Pedicle Screw System
- K162198 — GFS Ultimate
- K162230 — Fully Automatic Electronic Blood Pressure Monitor
- K162363 — V30 system, V-Form Handpiece BC Medium applicator
- K162403 — HyperBand
- K162577 — Dosimetry Check Version 5 Release 1
- K162994 — Capillus302, Capillus312, Capillus352
- K160045 — Heyman Packing Applicator Set
- K160564 — TroClose1200
- K160682 — CONTOUR NEXT ONE Blood Glucose Monitoring System
- K160923 — REDAPT Anteverted Cemented Liner
- K160959 — Xsert Lumbar Expandable Interbody System
- K161074 — Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
- K161735 — Non-contact Forehead Thermometer
- K161905 — Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
- K161909 — IQvitals Zone
- K161939 — Avance Abdominal Dressing Kit
- K161978 — AirFit N20
- K162097 — InTRAkit
- K162163 — UltraShape System
- K162232 — MOSS 100 Pedicle Screw System
- K162240 — ProMedTek Model C1400 Shortwave Diathermy Device
- K162322 — the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
- K162431 — Luna 3D Interbody Fusion System
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- K162583 — ALOKA LISENDO 880
- K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
- K163077 — LOGIQ E9, LOGIQ E9 XDClear 2.0
- K160663 — Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
- K160800 — DuoCem
- K161288 — LenSX Laser System
- K161597 — Tyber Medical BioTy® Nanotopography Trauma Screw
- K161692 — Diode Laser Therapy Machine
- K161999 — Aixplorer
- K162210 — touchTymp
- K162231 — iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
- K162379 — CD HORIZON® Spinal System
- K162537 — CAD/CAMouflage Milling Block
- K162541 — syngo Application Software
- K162914 — VenaCure EVLT NeverTouch Procedure Kit
- K163020 — Xperius Ultrasound System
- K153409 — Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
- K153714 — SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co
- K160049 — Charisma
- K160166 — X-MIND trium
- K160512 — HardyCHROM ESBL
- K160791 — AmorChem Titanium Porous Fixation Device
- K160881 — Tablo Console
- K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
- K161515 — eUnity
- K161665 — VLP Wrist Fracture System
- K161742 — Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
- K161753 — Hoffman LRF System
- K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
- K161856 — StatStrip Xpress Glucose Hospital Meter System
- K162265 — CushionCast Moldable Cushions
- K162278 — Digital Diagnostic Mobile X-ray System
- K162892 — Achieve Advance Mapping Catheter
- K162894 — AccuCath Intravascular Catheter
- K162990 — Optima XR240amx
- K153656 — PathLoc-SI Joint Fusion System
- K160718 — Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
- K161862 — ThermoPro
- K162252 — FasTouch Fixation System
- K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- K162941 — Ligasure Blunt Tip, Sealer/Divider, Nano-coated
- K160079 — rainbow Shine
- K160127 — iCodeConnect
- K160190 — Sunmed Control Syringes
- K160447 — Calprest NG
Data sourced from openFDA. This site is unofficial and independent of the FDA.