FDA 510(k) clearances — page 185
clearances on record, most recent first.
Clearances — page 185
18,401–18,500 of 176,479- K203667 — EzRay M (Model: VMX-P300)
- K203393 — FAST-FIX FLEX
- K203483 — Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
- K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
- K203568 — Hoffmann LRF System
- K203603 — Monopolar Hook
- K203794 — HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
- K190677 — EndoClot
- K191878 — DEX Device
- K192650 — i_Space 1.5T Superconducting Magnetic Resonance Imaging System
- K200429 — BEE Cages
- K201411 — Visage Breast Density
- K201418 — Sunset Heated CPAP Tube
- K201620 — Luna® G3 BPAP 25A
- K201752 — Disposable Pre-calibrated Suction
- K201801 — Rapid Acoustic Pulse Device
- K201838 — PediFlex Flexible Nail System
- K201993 — E-connect S Endo Motor with built-in Apex Locator
- K202221 — VX650
- K202282 — Neodent Implant System - Zirconia Implant System
- K202310 — Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
- K202358 — Protective Face Mask for Medical Use
- K202366 — MAGIC Infusion Catheter
- K202398 — Ti3Z Cervical Interbody System
- K202878 — Prase-AP Anterior Cervical Plate System
- K202970 — Ventway Sparrow
- K203220 — cobas BKV
- K203531 — XYPAN Expandable Lumbar Cage System
- K200289 — Michler-Kapp Cardiovascular Vent Catheter
- K200384 — HipXpert 3D Display and Anchoring Application
- K201016 — LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
- K201608 — GenesisZr UHT700 Zirconia
- K202524 — Standard Sterilizable Tray
- K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
- K202892 — Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
- K203223 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K203474 — Biomet Microfixation RibFix Advantage System
- K203507 — Vitality® Spinal Fixation System
- K203840 — BOSS 8F Balloon Guide Catheter
- K193386 — Wrist Electronic Sphygmomanometer
- K193387 — Arm Electronic Sphygmomanometer
- K193586 — Vivo 45 LS
- K203405 — EVOS Large Fragment Plating System
- K200922 — Altus Spine HA Pedicle Screw System
- K201300 — Airway Mobilescope
- K202199 — BTL-899ST
- K202934 — Blood Pressure Monitor
- K203104 — IBM iConnect Access
- K203482 — M.U.S.T. Pedicle Screw Extension and Long Tab Implants
- K203803 — VASOBand Vascular Compression Device
- K203849 — General Radiography CXDI-CS01
- K201468 — Pulse Oximeter
- K202742 — Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
- K202856 — Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
- K203327 — VERTACONNECT TLIF Cage
- K203453 — BD Hypodermic Syringe
- K203747 — Non-Contact Forehead Thermometer (Models UT306H & UT308H)
- K203797 — vatech A9 (Model : PHT-30CSS)
- K201187 — Cytoplast Titanium-Reinforced PTFE Membranes
- K202336 — Patient Monitor
- K193266 — MIIN
- K200037 — Piccolo Medical SmartPICC System
- K201066 — ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
- K201553 — Simply Iconic Implants
- K201696 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length
- K201782 — NuFace Trinity Plus Device
- K202415 — VirtueRF
- K202575 — ClearPoint Array System
- K202640 — Surgical Mask
- K202660 — SPRINT PNS System
- K202792 — BRIUS Clear Aligners
- K202858 — Flex-ThreadTM Distal Fibula Intramedullary Nail System
- K203010 — Platinum dRF Imaging System
- K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
- K203181 — Nerivio, FGD000075-4.7
- K203373 — Advanced Research Medical Trident SI Screw System
- K203656 — Non-Contact Forehead Thermometer (UT30H)
- K200731 — pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
- K201366 — Forwarts
- K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
- K202391 — DIR 800
- K202408 — cobas CTNG for use on cobas 6800/8800 systems
- K202507 — EEA Circular Stapler with Tri-Staple Technology
- K202595 — Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
- K202672 — Precision Delivery Infusion Set
- K202839 — Overlapped Compression Therapy
- K202904 — Surgical Face Mask
- K203189 — AEROCURE-MD
- K202629 — Dentsply Sirona Universal Spray Glazes
- K192913 — R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
- K200163 — Ava Fertility Tracker
- K201219 — Biocore9 Femoral Head Resurfacing Component
- K201685 — Potenza
- K202363 — HBP7 Settable Hemostatic Bone Putty
- K202833 — Sequel External Fixation Device
- K203153 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
- K203485 — SnugFit All-Suture Anchor
- K203719 — IntraSight Mobile
- K203726 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K200565 — Galapogos
Data sourced from openFDA. This site is unofficial and independent of the FDA.