FDA 510(k) clearances — page 258
clearances on record, most recent first.
Clearances — page 258
25,701–25,800 of 176,542- K180169 — EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
- K180221 — Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
- K180598 — UNIQA Dental Implants System
- K180734 — SmartLinx Vitals Plus Patient Monitoring System
- K180805 — Pure EP
- K181041 — 7D Surgical System Cranial Application
- K181836 — 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
- K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader
- K181946 — Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
- K173848 — Model WP-3840 and WP-3040
- K180248 — VascuEase IC-1200-WH
- K180351 — EndoWrist Mercury Bipolar Grasper
- K180634 — Surgical Silver Post Operative Dressing
- K181218 — AlignRT Plus
- K181234 — Self-adhesive Electrode
- K181828 — Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
- K181962 — CubeVue
- K173845 — Arthrex SwiveLock
- K180075 — MINUET LCD, MINUET LCD eco
- K180853 — EP Granules BVF
- K181346 — CystoSure Plus Catheter
- K181217 — VesoFlow Lite DVT Compression Device
- K181425 — APTUS® Proximal Humerus System
- K163578 — EasyTouch Safety Pen Needle
- K171435 — VirtuOst Vertebral Fracture Assessment
- K172280 — BH Sterilization Pouch
- K173461 — ECG recorder and Arrhythmia Detector
- K180155 — Arm Type Blood Pressure Monitor
- K180341 — FUJIFILM 600 Series Endoscope EG-600WR v2
- K180777 — K2M Expandable Interbody System
- K180825 — Fluent Fluid Management System
- K180907 — HORIZON TMS Therapy System
- K181146 — ASK System
- K181149 — Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
- K181197 — PHMB Foam Wound Dressing
- K181219 — OptiPillows EPAP Mask
- K181237 — Glidesheath Slender Tibial Pedal Kit
- K181323 — Atlas Gold PTA Dilatation Catheter
- K181479 — Ingenia Ambition S and Ingenia Ambition X
- K181549 — Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)
- K181796 — FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
- K181797 — Philips CT Big Bore Sliding Gantry Configuration
- K181809 — GRYPHON® Anchors with DYNACORD Suture
- K171547 — Qualisys Clinical System
- K171977 — miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
- K173280 — Neonatal ConchaSmart Breathing Circuits
- K173531 — Lockbox for Perfusor Space PCA Infusion Pump
- K173869 — Med-link Reusable Blood Pressure Cuff
- K173923 — Temporary Cardiac Pacing Wire
- K180150 — PL8 Wrist Reconstruction Plate
- K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K181094 — Polydioxanone Surgical Scaffold
- K181182 — DYNACORD Suture
- K181257 — PlasmaBlade X 3.0S, PlasmaBlade X 4.0
- K181432 — ProVectra 3D Prime with VistaSoft
- K181562 — Curiteva Anterior Cervical Plate System
- K181804 — Alphenix, INFX-8000C/B, V8.0
- K181830 — Azurion R2.0
- K180647 — BriefCase
- K180703 — VITA YZ ST and VITA YZ XT
- K180737 — Ultrasound Scanner System bk2300
- K180764 — TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
- K180770 — Propeller Sensor for Neohaler
- K181480 — MMD Tip
- K181666 — Smart One
- K181749 — SuperCable® Iso-Elastic Cerclage System
- K181772 — NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
- DEN180008 — MolecuLight i:X
- K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- K181272 — Picocare Family
- K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
- K181708 — MTS Plazomicin 0.016-256 µg/mL
- K172273 — 308nm Excimer System
- K180912 — TE7/TE5 Diagnostic Ultrasound System
- K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- K181431 — Laser Ureteral Catheter
- K181440 — Proficient® Posterior Cervical Spine System
- K181720 — Epiphany Cardio Server Mobile
- K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
- K181741 — IceSphere 1.5 CX Cryoablation Needle
- K172616 — Pulse Oximeter
- K173474 — RetiCapture
- K173808 — Voutia
- K180064 — OsteoFab Patient Specific Cranial Device
- K180076 — Ti 3Z Interbody System
- K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
- K180556 — Corelink Foundation 3D Anterior Lumbar System
- K180580 — Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
- K180627 — Macroduct Advanced Model 3710
- K181156 — Panther Fusion GBS Assay
- K181184 — OIC Intramedullary Nail System
- K181395 — Universal Cannula Seal (5-12 mm)
- K181452 — RCT800
- K181485 — EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
- K181554 — Stowe Pedicle Screw System
- K181694 — FlowTriever Retrieval/Aspiration System
- K181763 — FUJIFILM Ultrasonic Endoscope
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
- K173656 — Arthrex FibuLock Nail
- K180272 — Saniclave 250
Data sourced from openFDA. This site is unofficial and independent of the FDA.