FDA 510(k) clearances — page 194
clearances on record, most recent first.
Clearances — page 194
19,301–19,400 of 176,479- 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
- K201682 — RIST Radial Access Catheter
- K201795 — Transcend
- K201814 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit
- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K202685 — Eon Aligner
- K182906 — Portable Mesh Nebulizer
- K191982 — Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
- K193546 — Distal Centralizers
- K193583 — Restrata®
- K200051 — PUGGLE Enteral Feeding Pump and Feeding Set
- K200076 — Breezing Med
- K201103 — Xeleris V Processing and Review Systems
- K201273 — ImageSPECTRUM
- K201439 — Ventilator, Non-continuous (Respirator)
- K201756 — Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
- K201787 — Light Cure Dental Adhesive
- K201820 — NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System
- K202039 — Honorst Implant System
- K202277 — Surgical Face Mask
- K202446 — BD Preset Syringe & BD A-Line Syringe
Data sourced from openFDA. This site is unofficial and independent of the FDA.