FDA 510(k) clearances — page 242
clearances on record, most recent first.
Clearances — page 242
24,101–24,200 of 175,699- K172792 — Handheld Pulse Oximeter, Model SP-20
- K180478 — RectalPro 75 Endorectal Balloon
- K181369 — Immucise Intradermal Injection System
- K182248 — Aspire Venting Tube
- K182508 — Saxxony Posterior Cervical Thoracic System
- K182598 — VersaLink Fixation System
- K182674 — Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
- K172907 — ELAN 4 Air Motor System
- K180395 — EZ-IO Intraosseous Vascular Access System
- K180966 — FilmArray Pneumonia Panel
- K181469 — Cryotop®US-flash and Cryotop®US-scoop
- K181559 — Neurosign V4 Intraoperative Nerve Monitor
- K181759 — PowerDot PD-01MT
- K181890 — Brainlab Compatible K2M Navigation Instruments
- K181992 — Heat Pain Pro
- K182083 — Catalys Precision Laser System
- K182195 — Arco-SA Lumbar Cage System
- K182338 — Blue Sky Bio Computerized Orthodontic Bracket System
- K182360 — Teleport Microcatheter
- K182481 — HEM-6410T-ZM Wrist Blood Pressure Monitor
- K182484 — VERITON CT whole body SPECT/CT system
- K182530 — BIOEASY Multi-Drug Test Cup
- K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe
- K182649 — Enteral Feeding Syringes with Enfit Connectors
- K182808 — Aspida® Anterior Lumbar Plating System
- K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K173917 — neoClose PDS
- K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K180631 — Silk Voice
- K180732 — MiroCam Capsule Endoscope System
- K180949 — Steribite
- K181590 — Neurostructures Cavetto® [MAX] Cervical Cage System
- K181684 — VAMP Plus Venous/Arterial Blood Management Protection System
- K181918 — CardioInsight Cardiac Mapping System
- K182030 — Faros Mobile
- K182166 — Wrist Blood Pressure Monitor Model BP4350
- K182329 — SureCure Orthodontic Aligner System
- K182462 — Exactech Alteon Highly Polished Femoral Stem
- K182472 — Cepheid Xpert GBS LB Control Panel
- K182838 — Geistlich Derma-Gide
- K172999 — uWS-MR
- K173001 — uWS-CT
- K180381 — Powder Free Vinyl Patient Examination Gloves
- K180683 — Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
- K182162 — OptiBond eXTRa Universal
- K182220 — Curbell branded Patient Monitoring Cables
- K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack
- DEN170049 — Innovo
- K172668 — W Zirconia Implants
- K173857 — Elecsys Tacrolimus
- K173916 — Finapres Nova Noninvasive Hemodynamic Monitor
- K180469 — ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
- K180838 — SaliPen
- K181613 — MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
- K181757 — Günther Tulip® Vena Cava Filter Retrieval Set
- K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K181846 — ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System
- K181934 — Vivid T8, Vivid T9
- K181939 — icobrain
- K182216 — Merit Syringe
- K182279 — Merit Syringe
- K182425 — Universal Mesh - Sterile
- K182442 — MiniGuard Arterial Safety Valve
- K182444 — ERBEFLO Olympus Scope Port Connector
- K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite Set
- K181258 — ConnectedOR Hub with Device and Voice Control
- K181288 — Athelas One
- K181781 — DynaClipTM Bone Staple
- K182095 — Tina-quant Transferrin ver.2 (urine application)
- K182160 — 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
- K182559 — PREMIER Platinum HpSA PLUS
- DEN170056 — Parathyroid Detection (Model PTeye) System
- DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
- K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
- K180253 — Sheridan Endobronchial Tubes
- K180415 — Invia White Foam NPWT
- K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- K180786 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
- K181195 — ClearPoint System
- K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
- K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
- K181501 — Afina
- K181639 — Panta 2 Arthrodesis Nail System
- K181837 — Spinal Elements Ti-Bond coated devices
- K181911 — Interlude 100% Cotton Tampon
- K182077 — Mazor X System (Mazor X Stealth Edition)
- K182096 — Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
- K182104 — NavLock Trackers, Robotic Reference Frame
- K182110 — CDI Blood Parameter Monitoring System 550
- K182121 — CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
- K182127 — Wrist Blood Pressure Monitor Model BP6100
- K182270 — Cellene CO2 Laser System
- K182405 — Dexcom Pro Q Continuous Glucose Monitoring System
- K182427 — Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
- K182557 — MTS Eravacycline 0.002 - 32 µg/mL
- K182596 — Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182823 — PRODENSE Bone Graft Substitute
- K180247 — DAEHAN Adhesive Surface Electrodes
Data sourced from openFDA. This site is unofficial and independent of the FDA.