Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K160044, Image1 SPIES System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153203, Navigation Instruments
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160068, FilmArray Respiratory Panel (RP) for use with FilmArray Torch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153548, VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152082, Vesocclude Polymer Ligating Clip
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151307, ICONACY(TM) I-Hip (TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160434, ClearPoint System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152111, Symmetry Surgical Quad-Lock Container System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160845, Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152842, WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160364, VersaWrap Tendon Protector
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160629, InPen
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160147, CT TrueView
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161656, Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162047, LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161682, GE Lunar DXA Bone Densitometers with enCORE version 17
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160811, CRW STEREOTACTIC SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162955, Multi-Modality Tumor Tracking (MMTT) application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162532, WellDoc BlueStar, WellDoc BlueStar Rx
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161328, Cantab Mobile
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163529, ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163415, SlimShape System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K170648, ANTHEM CR Total Knee System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162603, Masimo O3 Regional Oximeter System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162569, YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161582, DORA Tubing Sets for Hemodialysis
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161533, A1C EZ Glycohemoglobin Analysis System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K170407, BD ChloraShield IV Dressing with CHG Antimicrobial
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171845, EMBA Hourglass Peripheral Embolization Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171540, Refobacin Bone Cement R
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163614, PENTAX Medical ED34-i10T, Video Duodenoscope
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162237, XO1 Knee Balancing System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180567, C3 Wave System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201199, Jada System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200037, Piccolo Medical SmartPICC System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212758, Autoplaque
Regular price $149.00 USDRegular priceUnit price / per