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Available for immediate download.
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FDA 510(k), K230214, Huma RPM (RPM)
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K230358, SAVI Dual (TM) Migraine Therapy
Regular price $1,224.01 USDRegular priceUnit price / per -
FDA 510(k), K230632, VersiHD with GuideMe software
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K230645, BeneHold™ Surgical Incise Drape with CHG antimicrobial II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K230775, SOFIA EX Intracranial Support Catheter
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K230857, TiLink-P SI Joint Fusion System
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231168, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231337, EndeavorRx
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231583, Route 92 Medical Full Length 054 Access System
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231820, SoloSmart Injection Pen Adapter (SoloSmart®)
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231849, MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K231914, Nurochek-II System
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K232053, SimpleSense-BP, SimpleSense-BP Software Application
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K232295, LAA Exclusion System
Regular price $271.74 USDRegular priceUnit price / per -
FDA 510(k), K232380, t:slim X2 Insulin Pump with Interoperable Technology
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K232809, Cross Vascular RF Generator and Footswitch (optional accessory)
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K232852, Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K233407, AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K233508, iFuse Bedrock Granite® Implant System
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K233705, CellFX Percutaneous Electrode System (SYS3000)
Regular price $2,150.28 USDRegular priceUnit price / per -
FDA 510(k), K233737, ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Regular price $1,234.91 USDRegular priceUnit price / per -
FDA 510(k), K240098, DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K760462, ELECTRICAL SHOCK DEVICE
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K770276, ELECTROTHERAPY APPARATUS E.T. 720
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K771203, DISP. HYPODERMIC NEEDLE
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K771708, WORRELL PATELLA
Regular price $64.94 USDRegular priceUnit price / per -
FDA 510(k), K780082, PERITONEAL DIALYSIS ADMIN. SET
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K780872, CYTOLOGY BRUSH
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K781156, DIALYSIS SYS., PDS 400 & RO 400
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K781318, DYNATRON 406 ELECTROTHERAPY APPARATUS
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K781892, LOCATOR, FOREIGN BODY
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K781967, HEMODIALYSIS CONCENTRATE, SODIU
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K790582, INTRAVASCULAR ADMINISTRATION SET Approval Letter
Regular price $51.94 USDRegular priceUnit price / per -
FDA 510(k), K791963, USCI MULLINS TRANSSEPTAL CATHETER INTRO.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K800023, LUNG AEROSOL UNIT
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K800800, PATELLAR COMPONENT FOR LUBINUS PATELLAR
Regular price $136.00 USDRegular priceUnit price / per