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Available for immediate download.
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FDA 510(k), K182732, JTL-250-01
Regular price $545.20 USDRegular priceUnit price / per -
FDA 510(k), K182766, Cufitec Surgical Mask
Regular price $673.17 USDRegular priceUnit price / per -
FDA 510(k), K182774, STOP U (Packed Black USA), STOP U (Packed White USA)
Regular price $662.05 USDRegular priceUnit price / per -
FDA 510(k), K182819, Decanting Device
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K182826, Ormco Spark Aligner System
Regular price $241.73 USDRegular priceUnit price / per -
FDA 510(k), K182848, ROSA ONE Spine application
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K182887, Masimo Rad-67 Pulse CO-Oximeter and Accessories
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182902, Precision1
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K182967, Visor System
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K183069, NobelZygoma 0°
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K183091, Elaris Pedicle Screw System
Regular price $153.34 USDRegular priceUnit price / per -
FDA 510(k), K183195, VIVO
Regular price $877.65 USDRegular priceUnit price / per -
FDA 510(k), K183206, Dexcom G6 Continuous Glucose Monitoring System
Regular price $1,271.30 USDRegular priceUnit price / per -
FDA 510(k), K183241, BrainScope TBI (Model: Ahead 400)
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K183282, Biovitals Analytics Engine
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K183319, Triangle System
Regular price $721.86 USDRegular priceUnit price / per -
FDA 510(k), K183370, PeraMobile and PeraWatch
Regular price $563.29 USDRegular priceUnit price / per -
FDA 510(k), K183453, VS3-IR
Regular price $664.83 USDRegular priceUnit price / per -
FDA 510(k), K183598, KeyPrint KeySplint Soft
Regular price $1,000.06 USDRegular priceUnit price / per -
FDA 510(k), K183635, PhotoFix Decellularized Bovine Pericardium
Regular price $116.94 USDRegular priceUnit price / per -
FDA 510(k), K183636, SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K183685, System, Nuclear Magnetic Resonance Imaging
Regular price $1,201.75 USDRegular priceUnit price / per -
FDA 510(k), K190010, Penumbra System Reperfusion Catheter JET 7
Regular price $564.68 USDRegular priceUnit price / per -
FDA 510(k), K190103, V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
Regular price $275.79 USDRegular priceUnit price / per -
FDA 510(k), K190180, CUSA Clarity Ultrasonic Surgical Aspirator System
Regular price $500.69 USDRegular priceUnit price / per -
FDA 510(k), K190208, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Regular price $951.37 USDRegular priceUnit price / per -
FDA 510(k), K190277, ProVate Vaginal Support
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(k), K190285, L300 Go System
Regular price $771.94 USDRegular priceUnit price / per -
FDA 510(k), K190292, Passio Pump Drainage System
Regular price $841.49 USDRegular priceUnit price / per -
FDA 510(k), K190338, 046 Zenith Flex
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K190548, BIOMONITOR III, Remote Assistant III
Regular price $1,535.59 USDRegular priceUnit price / per -
FDA 510(k), K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Regular price $732.99 USDRegular priceUnit price / per -
FDA 510(k), K190667, Sonopet iQ Sterilization Tray
Regular price $660.66 USDRegular priceUnit price / per -
FDA 510(k), K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Regular price $2,064.17 USDRegular priceUnit price / per -
FDA 510(k), K190718, Zygomatic Implants
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K190719, Artemis Eye System
Regular price $751.07 USDRegular priceUnit price / per