FDA 510(k) clearances — page 186
clearances on record, most recent first.
Clearances — page 186
18,501–18,600 of 175,699- K201828 — Voluson SWIFT, Voluson SWIFT+
- K202213 — syngo.CT Neuro Perfusion
- K202501 — Quantib Prostate
- K192921 — Zeos Aqua Vision Pump and tube
- K193631 — Stethee Pro 1, Stethee Pro Software System
- K200103 — BIOTEQ Drainage Catheter Set (One Step Type)
- K200434 — V20, V20a, AVSM3 SNF
- K200510 — Multi-LinkTM X2 ECG Adapter and Leadwires
- K201038 — Luce Ceramic Bracket
- K201377 — SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
- K201882 — AEON Endoscopic Stapler
- K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
- K202285 — Medline ENfit OTC Feeding Syringe
- K202609 — Instrument Clamps Electromagnetic
- K202740 — Klassic Knee System Tibial Inserts, PS-Max
- K192703 — Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
- K193542 — Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
- K200661 — Steripath Micro Blood Collection System
- K200767 — SilverStream Gel
- K200793 — LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
- K200810 — IPS CaseDesigner
- K201483 — Impression Material
- K201525 — ECG App
- K201777 — 31HN713D
- K201845 — Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
- K201917 — Piccolo Composite Proximal Tibia Plate System
- K201939 — GAIA Lumbar Interbody Fusion Device (LIFD) Family
- K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K201972 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
- K202309 — Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
- K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
- K202592 — Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
- K192949 — Flower Suture Anchor Set
- K200100 — Abutment Design
- K200725 — Citregen Tendon Interference Screw and Citrelock
- K200802 — Infrared Thermometer
- K200817 — URIS OMNI Narrow System & Prosthetic
- K201380 — Livocare Surgical Mask
- K201453 — Fortilink Cages with TiPlus Technology
- K202119 — AcuSee AS-P1000 System
- K202293 — Radiographic System Challenge X
- K202633 — ScanX Edge
- K200728 — Pitkar DeftFix System
- K200953 — NuVasive® Cohere® Thoracolumbar Interbody System
- K201701 — R3 HA Coated Acetabular Shells
- K202114 — CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
- K202253 — TruForm Sievers Annuloplasty Ring
- K202584 — iSleeve Introducer Set
- K200031 — Neonatal Phototherapy System
- K200217 — ClearEndoclip
- K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
- K201561 — Membrane Screws and Membrane Tacks
- K201659 — KHEIRON® Spinal Fixation System
- K202292 — UDE
- K202294 — Affirm Contrast Biopsy
- K190707 — Arthrex SoftStitch
- K191320 — Slow Wave DS8
- K193410 — SOZO Body Fluid Analyzer
- K200623 — OssGuide
- K200682 — BZF-29
- K201161 — Infrared Thermometer Model E127
- K201238 — Encore System
- K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application
- K201546 — OsOpia Synthetic Bone Void Filler
- K201559 — HAL for Medical Use(Lower Limb type)
- K201748 — Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
- K202170 — LiverMultiScan
- K202190 — Oculus-SA Lumbar Cage System
- K202207 — Materialise PKA Guide System
- K202218 — ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
- K202280 — Cleerly Labs v2.0
- K202557 — Quantum Workstation 12 Elite
- K200067 — MectaScope System
- K200127 — TELEGRAPH® EVOLUTION Humeral Nailing System
- K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
- K200710 — Infrared PT2L Digital No-Touch Thermometer
- K201359 — ECG Cables and Leadwires
- K201381 — Philips Avent Single/Double electric breast pump Advanced
- K201446 — HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
- K202357 — Nutricare Clear-ISOSAF Nasogastric Feeding Tube
- K192051 — THINQ
- K192077 — Tua Face Fitness / Tua Trend Face
- K200475 — IDS-iSYS Ostase BAP
- K201188 — Clear Guide SCENERGY
- K201928 — e-Ortho Shoulder Software
- K202376 — EverLift Submucosal Lifting Agent
- K202542 — Allura Vaginal Stent
- K202564 — DigitalDiagnost C90
- K202566 — Wiygul Catheter
- K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- K193131 — BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
- K193401 — Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
- K201790 — Dual Cure Resin Cement
- K201819 — Cadwell Apollo System
- K201895 — Cefaly Dual
- K202546 — LVivo Seamless
- K192717 — da Vinci SP Surgical System
- K193299 — VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
- K200557 — Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
- K201221 — Electrosurgical Generator
Data sourced from openFDA. This site is unofficial and independent of the FDA.