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Available for immediate download.
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FDA 510(k), K162237, XO1 Knee Balancing System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162383, Cadwell Sierra Summit, Cadwell Sierra Ascent
Regular price $1,228.18 USDRegular priceUnit price / per -
FDA 510(k), K162513, Arterys Software v2.0
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162524, AZUR CX Detachable 18 Peripheral Coil System
Regular price $1,930.64 USDRegular priceUnit price / per -
FDA 510(k), K162532, WellDoc BlueStar, WellDoc BlueStar Rx
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162569, YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162594, Craniomaxillofacial Distraction System (CMFD)
Regular price $737.16 USDRegular priceUnit price / per -
FDA 510(k), K162603, Masimo O3 Regional Oximeter System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162741, AxoGuard Nerve Connector
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K162759, KeraStat(R) Gel
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162770, Relign System
Regular price $998.67 USDRegular priceUnit price / per -
FDA 510(k), K162784, Silk'n HST
Regular price $500.69 USDRegular priceUnit price / per -
FDA 510(k), K162891, Complete Control System
Regular price $660.66 USDRegular priceUnit price / per -
FDA 510(k), K162955, Multi-Modality Tumor Tracking (MMTT) application
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K162999, V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
Regular price $724.64 USDRegular priceUnit price / per -
FDA 510(k), K163026, Ultra/Phonic Scanning Gel
Regular price $638.40 USDRegular priceUnit price / per -
FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel
Regular price $694.04 USDRegular priceUnit price / per -
FDA 510(k), K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Regular price $1,765.11 USDRegular priceUnit price / per -
FDA 510(k), K163105, Emprint Ablation System
Regular price $170.23 USDRegular priceUnit price / per -
FDA 510(k), K163109, OxyHeal 4000 Multiplace Hyperbaric Chamber Family
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163118, FLEX Microwave Ablation System and Accessories
Regular price $116.94 USDRegular priceUnit price / per -
FDA 510(k), K163154, Traxcess 7 Mini XSoft Guidewire
Regular price $506.25 USDRegular priceUnit price / per -
FDA 510(k), K163234, Biograph mMR with syngo MR E11P system software
Regular price $667.61 USDRegular priceUnit price / per -
FDA 510(k), K163415, SlimShape System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020
Regular price $472.87 USDRegular priceUnit price / per -
FDA 510(k), K163475, iVue
Regular price $720.47 USDRegular priceUnit price / per -
FDA 510(k), K163529, ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K163549, ClotTriever Thrombectomy System
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K163614, PENTAX Medical ED34-i10T, Video Duodenoscope
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K163689, 3M Clear Tray Aligner
Regular price $482.61 USDRegular priceUnit price / per -
FDA 510(k), K163714, OSSIX BONE
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K170008, Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K170155, EK12 Algorithm
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K170366, Laser Peripherals, LLC Family of Bare Laser Fibers
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K170407, BD ChloraShield IV Dressing with CHG Antimicrobial
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K170648, ANTHEM CR Total Knee System
Regular price $89.00 USDRegular priceUnit price / per