FDA 510(k) clearances — page 304
clearances on record, most recent first.
Clearances — page 304
30,301–30,400 of 175,699- 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
- K161417 — DePuy Synthes MAXFRAME Multi-Axial Correction System
- K161623 — Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
- K161628 — JAS Pulse(TM) Ultrasonic Therapy
- K161634 — IPS CaseDesigner
- K161738 — FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
- K162085 — i-CAT FLX V series / KaVo 3D eXam+ V series
- K162310 — XBraid TT Suture Tape
- K162539 — Solitaire 2 Revascularization Device
- K162576 — FORTEZZA Spinal Stabilization System
- K162656 — ESU-1 Electrosurgical Generator
- K152660 — HYPNOSPAD
- K160481 — Vivo 60
- K161433 — Insulia Diabetes Management Companion
- K161610 — EXPRT Revision Hip System
- K161649 — Virtu C Spinal Implant System
- K161768 — LUCAS 3 Chest Compression System
- K162262 — Tritanium® PL Cage
- K162781 — Magma Spark
- K162862 — Raycast High Precision Lung Board Solution
- K160924 — Amendia Interbody Fusion Devices
- K161011 — SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
- K161027 — Cadwell AmpliScan
- K161438 — Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
- K161493 — YO Home Sperm Test
- K160446 — MCP Bone Putty
- K161254 — Renovo Life Small Bone IM Nail System
- K161624 — MicrO2 OSA Device with Micro-Recorder
- K161638 — SPEEDTRAP Graft Preparation System
- K161952 — UltraShape System
- K162113 — Powder Free Nitrile Examination Gloves (Blue)
- K162257 — P1145 Dental Restorative
- K162273 — Materialise TKA Guide System
- K162863 — dS Small Extremity 16CH 1.5T Coil
- K162944 — Irix-C Cervical Integrated Fusion System
- K160153 — ABL90 FLEX PLUS
- K160278 — VSTAAR AdjusteR
- K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
- K160979 — Inclusive Abutments
- K161357 — LipiFlow Thermal Pulsation System
- K161636 — Lipogems System
- K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- K161703 — LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
- K161740 — D-SPECT Scanner, D-SPECT L Scanner
Data sourced from openFDA. This site is unofficial and independent of the FDA.