FDA 510(k) clearances — page 171
clearances on record, most recent first.
Clearances — page 171
17,001–17,100 of 176,479- 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
- K210349 — TKO Composite Bite Turbo Gel
- K210666 — Chest-CAD
- K210684 — Disposable Nitrile Medical Examination Glove
- K210719 — Change Healthcare Anatomical AI
- K211192 — Grivamax Family of Lasers, Models 272 and 148
- K211302 — Elecsys Syphilis
- K211859 — ACUSON Sequoia Diagnostic Ultrasound System
- K211906 — Vital Signs
- K201147 — Elos® Intramedullary Nailing System
- K210877 — Evolve System with the T3 Applicator
- K210963 — ENNOVATE Spinal System
- K211188 — xvision Spine system (XVS)
- K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- K211548 — POLARSTEM Calcar Reamer Guide
- K211910 — Z-6 Atrioseptostomy Catheter
- K211177 — Powder Free Vinyl Patient Examination Gloves
- K211239 — Vinyl Patient Examination Gloves
- K193397 — ADVIA Centaur® Digoxin assay
- K201473 — ExoAtlet-II
- K203108 — Ignite Stemless Anatomic Shoulder System
Data sourced from openFDA. This site is unofficial and independent of the FDA.