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Available for immediate download.
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FDA 510(k), K172593, XCelliStem Wound Powder
Regular price $642.57 USDRegular priceUnit price / per -
FDA 510(k), K172627, David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Regular price $742.72 USDRegular priceUnit price / per -
FDA 510(k), K172735, WR19 System
Regular price $816.45 USDRegular priceUnit price / per -
FDA 510(k), K172765, Smart Moves Complete
Regular price $655.09 USDRegular priceUnit price / per -
FDA 510(k), K172881, NeuroBlate System
Regular price $335.65 USDRegular priceUnit price / per -
FDA 510(k), K172938, Disposable Sterile Needle
Regular price $392.19 USDRegular priceUnit price / per -
FDA 510(k), K172955, LungVision Tool
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K173085, invendoscopy E210 System
Regular price $210.53 USDRegular priceUnit price / per -
FDA 510(k), K173156, Integrated CardioRespiratory System
Regular price $1,879.08 USDRegular priceUnit price / per -
FDA 510(k), K173244, superDimension Navigation System V7.2
Regular price $1,093.26 USDRegular priceUnit price / per -
FDA 510(k), K173372, ExactechGPS Total Shoulder Application
Regular price $262.53 USDRegular priceUnit price / per -
FDA 510(k), K173388, Exactech Equinoxe Stemless Shoulder
Regular price $302.83 USDRegular priceUnit price / per -
FDA 510(k), K173420, Radiomics App v1.0
Regular price $210.53 USDRegular priceUnit price / per -
FDA 510(k), K173443, AEON Endoscopic Stapler
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K173450, PRESS DUO elite, PRESS DUO elite AG
Regular price $1,294.95 USDRegular priceUnit price / per -
FDA 510(k), K173553, LUCAS 3 Chest Compression System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K173571, Element System with IBT Electrodes
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K173614, Penumbra Coil 400, Ruby Coil System, POD System
Regular price $486.78 USDRegular priceUnit price / per -
FDA 510(k), K173651, Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
Regular price $392.19 USDRegular priceUnit price / per -
FDA 510(k), K173681, reSET-O
Regular price $610.58 USDRegular priceUnit price / per -
FDA 510(k), K173730, Kinsa QuickCare Thermometer
Regular price $496.52 USDRegular priceUnit price / per -
FDA 510(k), K173756, Certus 140 2.45GHz Ablation System
Regular price $1,278.26 USDRegular priceUnit price / per -
FDA 510(k), K173761, Penumbra System Reperfusion Catheter JET 7
Regular price $1,232.36 USDRegular priceUnit price / per -
FDA 510(k), K173784, Smylic Invisible Clear Aligners
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K173785, Custom Clear Aligner System
Regular price $191.03 USDRegular priceUnit price / per -
FDA 510(k), K173796, Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Regular price $631.44 USDRegular priceUnit price / per -
FDA 510(k), K173841, AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K173860, s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Regular price $917.99 USDRegular priceUnit price / per -
FDA 510(k), K180045, Omnipod DASH Insulin Management System
Regular price $241.73 USDRegular priceUnit price / per -
FDA 510(k), K180068, ORISE Gel
Regular price $515.99 USDRegular priceUnit price / per -
FDA 510(k), K180192, Emprint Ablation Visualization Application
Regular price $837.31 USDRegular priceUnit price / per -
FDA 510(k), K180233, Eviva Stereotactic Guided Breast Biopsy System
Regular price $662.05 USDRegular priceUnit price / per -
FDA 510(k), K180241, Orthocaps Twinaligner
Regular price $1,094.94 USDRegular priceUnit price / per -
FDA 510(k), K180259, Sterile Hypodermic Needle for Single Use
Regular price $471.36 USDRegular priceUnit price / per -
FDA 510(k), K180329, ClotTriever Thrombectomy System
Regular price $302.83 USDRegular priceUnit price / per -
FDA 510(k), K180337, EUROPA Pedicle Screw System
Regular price $731.60 USDRegular priceUnit price / per