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Available for immediate download.
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FDA 510(k), K203043, Route 92 Medical 070 Access System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K203086, X-PLO2R
Regular price $538.25 USDRegular priceUnit price / per -
FDA 510(k), K203162, Advanix Biliary Stent with NaviFlex RX Delivery System
Regular price $450.28 USDRegular priceUnit price / per -
FDA 510(k), K203183, CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Regular price $2,022.44 USDRegular priceUnit price / per -
FDA 510(k), K203192, NaviCam Xpress Stomach System
Regular price $894.34 USDRegular priceUnit price / per -
FDA 510(k), K203215, Radius T wearable thermometer
Regular price $478.43 USDRegular priceUnit price / per -
FDA 510(k), K203247, iFuse-TORQ™ Implant System
Regular price $1,064.05 USDRegular priceUnit price / per -
FDA 510(k), K203343, Wesper Lab
Regular price $764.98 USDRegular priceUnit price / per -
FDA 510(k), K203373, Advanced Research Medical Trident SI Screw System
Regular price $489.56 USDRegular priceUnit price / per -
FDA 510(k), K203401, Neocis Guidance System (NGS) with Patient Splints (EPS)
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K203459, SafeCross Transseptal Puncture and Introducer (TSP/I) System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K203550, ActivSight Intraoperative Imaging System
Regular price $808.10 USDRegular priceUnit price / per -
FDA 510(k), K203629, IDx-DR
Regular price $472.87 USDRegular priceUnit price / per -
FDA 510(k), K203714, NuVasive Thoracolumbar Interbody Systems
Regular price $1,976.54 USDRegular priceUnit price / per -
FDA 510(k), K203722, RayPilot System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K203737, Spark Clear Aligner System
Regular price $465.92 USDRegular priceUnit price / per -
FDA 510(k), K203764, TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K203782, Nanox Cart X-ray System
Regular price $1,360.33 USDRegular priceUnit price / per -
FDA 510(k), K203835, MIS Solution
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K210099, Meticuly Patient-Specific Titanium Mesh Implant
Regular price $737.16 USDRegular priceUnit price / per -
FDA 510(k), K210133, Current Health Monitoring System Gen 2 (G2)
Regular price $1,055.70 USDRegular priceUnit price / per -
FDA 510(k), K210176, FlowSaver Blood Filter
Regular price $618.93 USDRegular priceUnit price / per -
FDA 510(k), K210187, Overjet Dental Assist
Regular price $774.72 USDRegular priceUnit price / per -
FDA 510(k), K210269, PowerDot PD-01MT2 Muscle Stimulator
Regular price $302.83 USDRegular priceUnit price / per -
FDA 510(k), K210293, AtriClip LAA Exclusion System
Regular price $279.44 USDRegular priceUnit price / per -
FDA 510(k), K210484, LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Regular price $488.17 USDRegular priceUnit price / per -
FDA 510(k), K210544, Medtronic Extended infusion set
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K210635, Route 92 Medical Full Length 088 Access System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K210668, TSolution One Total Knee Application
Regular price $499.30 USDRegular priceUnit price / per -
FDA 510(k), K210710, PENTAX Medical Video Duedenoscope ED34-i10T2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210996, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K211010, Illusion Aligners
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K211129, Neocis Guidance System (NGS) with Intraoral Fiducial Array
Regular price $482.61 USDRegular priceUnit price / per -
FDA 510(k), K211190, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Regular price $542.42 USDRegular priceUnit price / per -
FDA 510(k), K211585, Bodyport Cardiac Scale
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211654, Penumbra System (Reperfusion Catheter RED 72)
Regular price $149.00 USDRegular priceUnit price / per