FDA 510(k) clearances — page 330
clearances on record, most recent first.
Clearances — page 330
32,901–33,000 of 176,542- K150921 — Orbit Infusion Set
- K151977 — icotec Pedicle System
- K152107 — HealthChek Network Health Station
- K152430 — All Poly Tibial Component
- K152794 — Cytosponge Cell Collection Device
- K153229 — Superbium
- K153753 — TelioCAD Multi
- K160376 — EndoSize
- K160461 — Arthrex iBalance BiCompartmental Arthroplasty System
- K160517 — ARIES System
- K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K152056 — Winco Model S550 Stretchair
- K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- K152581 — LifeGlobal Micro Tips
- K152836 — TREFOIL System
- K152995 — BioMonitor 2-AF, BioMonitor 2-S
- K153043 — Noris Medical MBI Dental Implant System
- K153377 — Hoffmann LRF (Limb Reconstruction Frame) System
- K160390 — Map-it Diagnostic Mapping Catheters
- K143612 — LifeCare PCA Infusion System
- K151909 — Noris Medical Zygomatic Dental Implant System
- K152184 — MagView BIOMAGNETOMETER SYSTEM
- K152305 — Nihon Kohden Afib Detection Program QP-039P
- K153063 — PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
- K153084 — Nephros S100
- K153098 — KLOCKNER VEGA DENTAL IMPLANT SYSTEM
- K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K153305 — EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
- K153411 — 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
- K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer
- K153446 — OLYMPIC Posterior Spinal Fixation System
- K153464 — FDR D-EVO flat Panel Detector System
- K153581 — Bladder Scanner
- K153622 — First Ray Internal Bone Staple System
- K153639 — OneQ-SL s-Clean Implant System
- K153766 — Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
- K160093 — RayStation
- K160223 — VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
- K160266 — ICONACY(TM) I-Hip(TM)
- K160299 — geko(TM) Plus R-2 Neuromuscular Stimulator
- K160407 — spineEOS
- K160579 — Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
- DEN150028 — PneumoLiner
- K142754 — Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
- K152194 — transGlide Expandable Introducer
- K152439 — U2 Bipolar Implant and 22mm Femoral Head
- K152700 — StrataMR Valves and Shunts
- K152864 — Merge Hemo
- K153093 — FIRMap Catheter
- K153163 — ReGrasp
- K153555 — EM ENT Navigated Suctions
- K160343 — SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
- K160351 — CX50N, CX50YQS
- K160355 — CX20N(CX20PUX)
- K160651 — BD FlowSmart Set, MiniMed Pro-Set
- K160659 — ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
- K151983 — KLS Martin LSS Plating System
- K153293 — Extension Set
- K153482 — KLS Martin Thoracic Plating System
- K153566 — Magma System
- K153634 — Wireless Earlens Light Driven Hearing Aid
- K153722 — SMR 3-Pegs Glenoids
- K160807 — EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K151503 — NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
- K151683 — SleepWeaver Advance Pediatric Nasal CPAP Mask
- K152652 — PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
- K152947 — Disposable Temporary Pacing Cable
- K153009 — ULTRA Telescopes
- K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
- K160160 — Non-Telescopic PenEvac
- K160360 — Barrx FLEX RFA Energy Generator
- K160368 — EVO platform
- K160734 — SonoSite SII Ultrasound System
- K151650 — SMARTez elastomeric infusion pump
- K151967 — Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
- K152228 — Hydroven 12, Hydroven 12 Garments
- K152479 — HG Pro Nitrile Powder Free Examination Gloves
- K153481 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
- K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
- K160283 — S45 Digital Color Doppler Ultrasound System
- K160325 — PRECICE Intramedullary Limb Lengthening System
- K160464 — Opticage(R) Expandable Interbody Fusion Device
- K160790 — Acclarix LX8 Diagnostic Ultrasound System
- K143548 — TRUE METRIX GO Self Monitoring Blood Glucose System
- K143690 — Ekso (version 1.1) and Ekso GT (version 1.2)
- K151156 — Fiagon Navigation System
- K152881 — SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
- K153249 — Pulpdent Solo Flowable Composite with MCP
- K153263 — Aquilion Lightning, TSX-035A/4 and /5, V7.0
- K153486 — Affirm Prone Biopsy System
- K153562 — Powder Free Blue Nitrile Examination Glove
- K153583 — BioVision Plus
- K160258 — X5 Digital Color Doppler Ultrasound System
- K160318 — PlasmaFlow
- K160320 — Premier
- K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- K151612 — NewTom VGi evo
- K151832 — NOVATECH TALCAIR
- K151932 — Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
- K151997 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
Data sourced from openFDA. This site is unofficial and independent of the FDA.