FDA 510(k) clearances — page 163
clearances on record, most recent first.
Clearances — page 163
16,201–16,300 of 175,699- K203359 — BD Flu+ Syringe
- K203431 — Disposable Ear Thermometer Probe Cover
- K210189 — Pac-Dent Denture Base Resin
- K210379 — Broncho Videoscope System
- K210409 — Disposable Surgical Face Mask
- K210856 — Purism Disposable Surgical Mask
- K211014 — Portray
- K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array
- K211225 — MIS Ti-base abutment
- K211335 — Diode Laser Machine, Model Number: BM-100
- K211395 — NIO-I
- K211455 — Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
- K211489 — Dental Impression Material
- K211497 — Surgical Mask
- K211646 — FINE Osteotomy
- K211677 — ELEOS Limb Salvage System
- K211839 — Electrode Market Disposable Surface Electrodes
- K211861 — TAIJI Professional Series Level 3 Surgical Face Mask
- K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K211991 — Catalyst R1 Reverse Shoulder System
- K211994 — Braun Silk.expert Mini
- K201326 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
- K210016 — Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
- K210469 — Insight Agile DRF
- K210635 — Route 92 Medical Full Length 088 Access System
- K210664 — DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
- K210736 — doctorgram Stethoscope DES-I
- K210791 — Us2.v1
- K210884 — 1Derful HS, 1Derful HT
- K211247 — PET VCAR
- K211279 — Volpara Imaging Software
- K211325 — Senhance Surgical System
- K211655 — aPROMISE
- K211932 — Fixxsure Anterior Lumbar Plate and Screw System
- K211989 — Aveir Introducer
- K211990 — Rist 071 Radial Access Guide Catheter
- K212074 — ClariCT.AI
- K200129 — OncoMate MSI Dx Analysis System
- K210412 — Pac-Dent Ceramic Nanohybrid Resin
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
- K211643 — Vision Monitor - MonpackONE
- K211984 — MASC Surgical Mask
- K211262 — Disposable Vinyl Nitrile Synthetic Gloves Powder Free
- K211363 — Medical Face Mask
- K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
- K201265 — Disposable Microwave Therapeutic Antennas
- K201887 — VS Newborn Heart Rate Monitor
- K202060 — Disposable IV catheter
- K202296 — Infrared Forehead Thermometer, Model BSX976
- K202612 — Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
- K202727 — Peregrine Endoscopy System
- K210159 — IntraLock System
- K210185 — CardioCurve Steerable Sheath
- K210311 — Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
- K210382 — Blustone Synergy Diamond SA Cervical System
- K210468 — SC1 Handheld Ultrasound Imaging System (Model: SC1)
- K210903 — IS Multi Unit Abutment System
- K211012 — Nitrile Patient Examination Gloves
- K211249 — Altor Safety 3-Ply Surgical Mask (Model:62222)
- K211316 — da Vinci SP Surgical System (SP1098)
- K211386 — MySpine WebPlanner & MyBalance
- K211602 — Klassic Knee System
- K211951 — GI Genius
- K212030 — Flex-Thread Distal Fibula lntramedullary Nail System
- K212052 — HMB32 Dialysis Solution
- K202582 — Arthrex SynergyID Endoscopic Imaging System
- K202603 — Temp Pal
- K203175 — POLARSTEM Cemented Femoral Stem
- K203214 — DemarkQ WOW, DemarkQ POP
- K203411 — syngo.CT Skull Unfolding
- K203694 — DELTA XTEND Reverse Shoulder System
- K210143 — Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
- K210176 — FlowSaver Blood Filter
- K210391 — Single-use medical face mask
- K210415 — QSM software, QSMetric
- K210579 — WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
- K211220 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
- K211633 — Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
- K211688 — DC-Air and Athlos-1 and Athlos-Air
- K211939 — ExacTrac Dynamic
- K211944 — Medline UNITE® Digital Fusion Screw System
- K211968 — NIO+ Adult
- K212008 — Reveal LINQ Insertable Cardiac Monitor
- K193352 — AbutmentCAD
- K201009 — CHIRAVAC Blood Collection Needles
- K202868 — LifeSignals Multi-Parameter Remote Monitoring Platform
- K203271 — Aduro light therapy Handheld
- K203534 — Surgical face mask (Model: Flat Ear Loop/CN102)
- K210059 — Promisemed Insulin Pen Needle
- K210686 — Nitrile Patient Examination Glove
- K210688 — AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
- K210970 — Single-Use Surgical Mask Model FE2311B
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K211901 — MolecuLightDX
- K211958 — CD Horizon Spinal System
- K203168 — LifeLens Wireless ECG Monitor
- K203712 — The Slide
- K203765 — ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray
- K210129 — RF Thermal System
Data sourced from openFDA. This site is unofficial and independent of the FDA.