FDA 510(k) clearances — page 309
clearances on record, most recent first.
Clearances — page 309
30,801–30,900 of 176,542- K163000 — AMPLATZER TorqVue 45x45 Delivery Sheath
- K163018 — Zilver 635 Biliary Stent
- K163055 — Reprocessed Kendall SCD Express Foot Cuff
- K163539 — Ez3D-i / E3
- K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- K160309 — Neurosoft TMS
- K160538 — Sysmex XN-L Automated Hematology Analyzer
- K160585 — XN CAL
- K160586 — XN-L CHECK
- K160588 — XN CHECK BF
- K160590 — XN CHECK
- K160925 — VPS Rhythm Device with TipTracker Technology
- K160949 — Go Dose System
- K160981 — Patient Monitor
- K160982 — Sphynx
- K161032 — neon3 universal OCT spinal stabilization
- K161127 — The Small PLATEAU (PLATEAU-C) Spacer System
- K161399 — Neocis Guidance System
- K161467 — HydraGuard 10 UltraFilter
- K161550 — DynaMesh-VENTRAL
- K161639 — Y-MIC
- K162022 — Collagentex Rx-1
- K162282 — CardioChek Plus Test System, CardioChek Home Test System
- K162352 — derma+flex QS High Viscosity Tissue Adhesive
- K162446 — FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
- K162478 — ivWatch
- K162721 — Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- K163068 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- K163306 — Lithoplasty Peripheral Balloon Dilatation Catheter +2 more
- DEN150055 — AeroForm Tissue Expander System
- DEN160020 — CipherOx CRI Tablet
- K152778 — TRACOE Cuff Pressure Monitor
- K153426 — Ox-Imager CS
- K160942 — Sonablate
- K161197 — Orthodontic Screw
- K161215 — Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
- K161307 — NICO Myriad
- K161566 — DMS Disposable Subdermal Needle Electrodes
- K161716 — TEETHAN 2.0
- K161723 — ulrich Transfer Set
- K161916 — TelePatch Cardiac Monitor
- K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- K162003 — IMSE Cervical Cage
- K162128 — Scope Buddy Plus Endoscope Flushing Aid
- K162251 — Reprocessed Viking Diagnostic Electrophysiology Catheters
- K162259 — DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K162421 — IntelliCartTM System
- K162436 — EndoVac Pure
- K162555 — EVS 4343, EVS 4343G
- K162677 — L- OVC
- K162717 — Evolution Esophageal Stent System Partially Covered
- K163086 — VLP MINI-MOD 2.0mm Column Plates
- K163264 — Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
- K163266 — Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
- K163311 — GMK Revision Femoral Distal Augmentation
- DEN150022 — Ultravision Visual Clearing System
- K160574 — K3PRO SURGICAL TRAY
- K160879 — CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
- K160928 — Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
- K162344 — INNOLUX RIC
- K162461 — Endoform Plastics and Reconstructive Matrix
- K162630 — CP Relief Wand-OTC
- K163301 — CD HORIZON® Spinal System
- DEN150057 — Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- DEN160005 — Hem-Avert Perianal Stabilizer
- K160007 — Paclitaxel Sets
- K160515 — PS2 Knee System
- K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
- K160771 — Destiknee Total Knee System
- K160854 — MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
- K161259 — KLS Martin Cannulated Headless Screws
- K161390 — Vinyl Exam Gloves, Powder Free, Clear
- K161739 — Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
- K161871 — EVA (Enhanced Visual Assessment) System
- K162081 — BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
- K162854 — Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
- K162955 — Multi-Modality Tumor Tracking (MMTT) application
- K160707 — CustomizedBone Service
- DEN150038 — CleanCisionTM Wound Retraction and Protection System
- K160614 — Xcite Clinical Station
- K160742 — NoCoding1 Plus Blood Glucose Monitoring System
- K161237 — HyperView Hyperspectral Tissue Oxygenation Measurement System
- K161713 — Dentium CAD/CAM Abutments
- K161837 — ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- K161947 — Chagas Detect Plus Rapid Test
- K162020 — VITROS Chemistry Products Cl- Slides
- K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K162302 — Somatom Confidence ® RT Pro
- K162373 — LC Bead LUMI
- K162578 — Zerona Z6 OTC
- K162638 — CETRA Anterior Cervical Plate System
- K163213 — Revolution CT
- K163236 — COOLIEF Cooled Radiofrequency Kit
- K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System
- K160798 — IPS e.max® Press Abutment Solutions for Viteo Base Ti
- K160836 — Menai System
- K160849 — WS(TM) Far-Infrared Therapy Unit, Model KP-B210
- K160852 — Zia
- K161060 — Arthrex iBalance UKA System Vitamin E Tibial Bearing
- K162192 — BluePro
Data sourced from openFDA. This site is unofficial and independent of the FDA.