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Available for immediate download.
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FDA 510(k), K171933, ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
Regular price $630.05 USDRegular priceUnit price / per -
FDA 510(k), K171992, SculpSure
Regular price $785.85 USDRegular priceUnit price / per -
FDA 510(k), K172007, CamX Triton HD Proxi Head
Regular price $610.58 USDRegular priceUnit price / per -
FDA 510(k), K172085, PhotoFix Decellularized Bovine Pericardium
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K172257, TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
Regular price $1,151.68 USDRegular priceUnit price / per -
FDA 510(k), K172284, NAPA LP-15 Airway Pressure Monitor
Regular price $566.07 USDRegular priceUnit price / per -
FDA 510(k), K172322, Atellica IM Total hCG (ThCG)
Regular price $2,071.13 USDRegular priceUnit price / per -
FDA 510(k), K172457, Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
Regular price $2,474.38 USDRegular priceUnit price / per -
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