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Available for immediate download.
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FDA 510(k), K180567, C3 Wave System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K180820, Tono Vue Non-Contact Tonometer
Regular price $881.82 USDRegular priceUnit price / perSale price $881.82 USD -
FDA 510(k), K180854, Voyager Trajectory Array Guide (V-TAG)
Regular price $726.03 USDRegular priceUnit price / perSale price $726.03 USD -
FDA 510(k), K181131, Accu-Chek Guide Me Blood Glucose Monitoring System
Regular price $933.29 USDRegular priceUnit price / perSale price $933.29 USD -
FDA 510(k), K181179, BrainScope One
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K181180, OSSIO™ Pin Product Family
Regular price $561.89 USDRegular priceUnit price / perSale price $561.89 USD -
FDA 510(k), K181240, Rhino-Laryngo Fiberscope Olympus ENF-GP2
Regular price $886.00 USDRegular priceUnit price / perSale price $886.00 USD -
FDA 510(k), K181295, Genesys Spine AIS-C Cervical Stand-Alone System
Regular price $552.16 USDRegular priceUnit price / perSale price $552.16 USD -
FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels
Regular price $682.91 USDRegular priceUnit price / perSale price $682.91 USD -
FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Regular price $1,434.05 USDRegular priceUnit price / perSale price $1,434.05 USD -
FDA 510(k), K181557, INFINITY Total Ankle System
Regular price $517.38 USDRegular priceUnit price / perSale price $517.38 USD -
FDA 510(k), K181643, SmartBag (SmartPouch)
Regular price $1,535.59 USDRegular priceUnit price / perSale price $1,535.59 USD -
FDA 510(k), K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Regular price $1,279.65 USDRegular priceUnit price / perSale price $1,279.65 USD -
FDA 510(k), K181704, Transpara
Regular price $1,111.34 USDRegular priceUnit price / perSale price $1,111.34 USD -
FDA 510(k), K181784, Spectra S3 Plus
Regular price $554.94 USDRegular priceUnit price / perSale price $554.94 USD -
FDA 510(k), K181965, Restore Toothpaste
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K181974, MyoSure XL Tissue Removal Device for Fluent
Regular price $367.15 USDRegular priceUnit price / perSale price $367.15 USD -
FDA 510(k), K182038, URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Regular price $3,462.13 USDRegular priceUnit price / perSale price $3,462.13 USD -
FDA 510(k), K182073, BcSs-PICNI-2000 Sensor
Regular price $1,959.85 USDRegular priceUnit price / perSale price $1,959.85 USD -
FDA 510(k), K182075, BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Regular price $3,165.85 USDRegular priceUnit price / perSale price $3,165.85 USD -
FDA 510(k), K182265, CodMan Certas Plus Programmable Valve
Regular price $799.76 USDRegular priceUnit price / perSale price $799.76 USD -
FDA 510(k), K182329, SureCure Orthodontic Aligner System
Regular price $153.34 USDRegular priceUnit price / perSale price $153.34 USD -
FDA 510(k), K182531, ClotTriever Thrombectomy System
Regular price $77.94 USDRegular priceUnit price / perSale price $77.94 USD -
FDA 510(k), K182618, SleepImage System
Regular price $1,019.53 USDRegular priceUnit price / perSale price $1,019.53 USD -
FDA 510(k), K182630, Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Regular price $1,375.63 USDRegular priceUnit price / perSale price $1,375.63 USD -
FDA 510(k), K182651, HbA1c Advanced
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K182687, Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K182732, JTL-250-01
Regular price $545.20 USDRegular priceUnit price / perSale price $545.20 USD -
FDA 510(k), K182766, Cufitec Surgical Mask
Regular price $673.17 USDRegular priceUnit price / perSale price $673.17 USD -
FDA 510(k), K182774, STOP U (Packed Black USA), STOP U (Packed White USA)
Regular price $662.05 USDRegular priceUnit price / perSale price $662.05 USD -
FDA 510(k), K182819, Decanting Device
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K182826, Ormco Spark Aligner System
Regular price $241.73 USDRegular priceUnit price / perSale price $241.73 USD -
FDA 510(k), K182848, ROSA ONE Spine application
Regular price $415.84 USDRegular priceUnit price / perSale price $415.84 USD -
FDA 510(k), K182887, Masimo Rad-67 Pulse CO-Oximeter and Accessories
Regular price $149.00 USDRegular priceUnit price / perSale price $149.00 USD -
FDA 510(k), K182902, Precision1
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K182967, Visor System
Regular price $415.84 USDRegular priceUnit price / perSale price $415.84 USD