FDA 510(k) clearances — page 256
clearances on record, most recent first.
Clearances — page 256
25,501–25,600 of 176,542- K173665 — AMSafe Sure-Lok Needle-Free Connector
- K173921 — HD-500 Video Endoscope System
- K173976 — Masimo Acoustic Respiration Sensors, infant and neonate
- K181662 — Iridex TruFocus LIO Premiere
- K181878 — Kiierr 272 Laser, Kiierr 148 Laser
- K182138 — Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
- K173568 — NeoBase 2 Non-derivatized MSMS Kit
- K173765 — Surveyor Patient Monitor
- K181249 — EUSRA RF Electrode
- K181314 — IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
- K181510 — ECHOLASER X4
- K181532 — Exactech Alteon Monobloc Revision Stem
- K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
- K181167 — Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
- K181466 — Cadwell Zenith System
- K171549 — Intelligent Mesh Nebulizer
- K173368 — Reusable & Disposable SpO2 Sensors
- K173477 — ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
- K180006 — AmCAD-UT Detection 2.2
- K180185 — BIO-C REPAIR
- K180866 — CareSens S Fit Blood Glucose Monitoring System
- K181225 — ALTAPORE
- K181228 — IlluminOss Bone Stabilization System
- K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
- K181482 — myTAP2
- K181543 — Cure OPEL-C Plate System
- K182107 — CarriGen PF
- K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
- K173380 — b-ONE® Total Hip System
- K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K173623 — Anchor plate
- K173648 — Spectralis HRA + OCT and variants
- K180536 — Neodent Implant System GM Line
- K180888 — LYFT
- K181262 — SpineJack Expansion Kit
- K181486 — DEKA Motus AY
- K181513 — Arthrex PushLock Tenodesis Anchor
- K181997 — Swiss LithoClast Trilogy
- K182024 — Dissecting Balloon System
- K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
- K173205 — Equinox Advantage
- K180073 — Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
- K180496 — TruClear Elite Hysteroscope
- K180610 — Geister retractor for neuro - and spine surgery
- K180802 — Meta P&Bond
- K181104 — Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
- K181185 — Change Healthcare Enterprise Viewer
- K181295 — Genesys Spine AIS-C Cervical Stand-Alone System
- K181471 — ACCUFUSE Cervical System
- K181502 — Zio AT ECG Monitoring System, ZEUS System
- K181740 — ZELTIQ CoolSculpting System
- K181799 — ResCUBE Ligament Fixation System
- K182054 — Natrelle 133S Tissue Expander
- K182119 — CD HORIZON Spinal System
- K173952 — Universal SmartECG
- K181069 — Disposable Insulin Pen Needle
- K181367 — Tenex Health TX System with the TXP MicroTip
- K181683 — BD MAX CT/GC/TV 20-Day QC Panel
- K181313 — BenQ Diagnostic Ultrasound System
- K181408 — JO Classic Hybrid Personal Lubricant
- K181473 — DENV Detect NS1 ELISA
- K181483 — Tranquil Interbody System
- K181582 — DemeTECH DemeDIOX absorbable surgical suture
- K172830 — Double Medical Femoral Nail System
- K173541 — EPINAUT
- K173673 — AcuSnare Polypectomy Snare
- K173771 — IOLMaster 700
- K173978 — CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
- K180040 — NC TREK RX Coronary Dilatation Catheter +6 more
- K180179 — Firebird® Spinal Fixation Systems: Firebird System +6 more
- K180373 — CancelleX Porous Titanium Lumbar Interbody Device
- K181009 — APTUS CMC-I Fusion Plate System
- K181035 — AOS Small Fragment Plating System Lite
- K181060 — Solitaire 2 and Solitaire Platinum Revascularization Device
- K181386 — NuVasive Brigade Lateral System
- K181609 — RadiForce GX560, GX560-AR
- K182057 — EasyMax BT Self-Monitoring Blood Glucose System
- DEN170090 — MATRx plus
- K170050 — Z-CAD smile
- K173657 — Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
- K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
- K173784 — Smylic Invisible Clear Aligners
- K173890 — GMK Sphere - Kinematic Alignment
- K180173 — Freespira
- K180186 — Stat Profile Prime Plus Analyzer System
- K181333 — ADVIA Centaur Herpes-1 IgG
- K181334 — ADVIA Centaur Herpes-2 IgG
- K181439 — SpyGlass DS and DS II Direct Visualization System
- K181635 — GMK Sphere CR Tibial Inserts
- K181974 — MyoSure XL Tissue Removal Device for Fluent
- K173024 — Non-invasive blood pressure measurement systems
- K180542 — NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
- K181312 — GrandioSO x-tra
- K181954 — autoLog IQ Autotransfusion System
- K173197 — Reusable NIBP Cuff
- K173658 — Confidence Blood Glucose Monitoring System
- K180698 — PICO 7 Single Use Negative Pressure Wound Therapy System
- K180957 — exGraft, exGraft Carbon ePTFE Vascular Grafts
- K181013 — Fever Scout
- K181379 — H. PYLORI QUIK CHEK
Data sourced from openFDA. This site is unofficial and independent of the FDA.