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), K201840, Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022595, WILSON-COOK CYSTOTOME
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211401, SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052643, EPICERAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122361, T:CONNECT DATA MANAGEMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141758, T:SLIM INSULIN DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160482, t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162080, t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200761, Tenax Laser Resistant Endotracheal Tube
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203712, The Slide
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211069, EndSnorZ Sleep Appliance
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111520, IPC POWEREASE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192880, InferRead Lung CT.AI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110771, BD SINGLE USE, HYPODERMIC SYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042936, SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172881, NeuroBlate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171255, Monteris Medical NeuroBlate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K170724, NeuroBlate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162762, NeuroBlate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143457, NeuroBlate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131955, NEUROBLATE(TM) SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162191, NAVILAS Laser System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130368, AUTOLITH TOUCH; URO TOUCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982577, NEUFINISH RESURFACING CREAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161399, Neocis Guidance System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211129, Neocis Guidance System (NGS) with Intraoral Fiducial Array
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210668, TSolution One Total Knee Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040657, BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203401, Neocis Guidance System (NGS) with Patient Splints (EPS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202264, Neocis Guidance System (NGS) with Yomi Plan v2.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202100, Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201255, TSolution® One Total Knee Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200805, Neocis Guidance System (NGS) with Patient Splints
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193135, TSolution One Total Knee Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191605, Neocis Guidance System (NGS)
Regular price $149.00 USDRegular priceUnit price / per