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Available for immediate download.
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FDA 510(k), K211785, CASSATT™ SIJ Fixation System
Regular price $596.67 USDRegular priceUnit price / per -
FDA 510(k), K211855, Ion Facet Screw System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211878, LiquiBand XL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212156, ABCcolla Bone Matrix
Regular price $493.74 USDRegular priceUnit price / per -
FDA 510(k), K212616, Koios DS
Regular price $859.57 USDRegular priceUnit price / per -
FDA 510(k), K212696, Aspira Pleural Drainage System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212758, Autoplaque
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212947, Trinity Plus Wrinkle Reducer
Regular price $486.78 USDRegular priceUnit price / per -
FDA 510(k), K213562, DTX Studio Clinic 3.0
Regular price $876.26 USDRegular priceUnit price / per -
FDA 510(k), K213854, SavvyWire
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213959, MagnetOs Flex Matrix
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K214048, Millipede 088 Access Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220131, KYPHON VuE Bone Cement
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220195, iFuse Bedrock Granite™ Implant System
Regular price $1,667.74 USDRegular priceUnit price / per -
FDA 510(k), K220606, Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220635, Heater-Cooler System 3T
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220942, 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela
Regular price $2,374.37 USDRegular priceUnit price / per -
FDA 510(k), K221007, cobas HCV
Regular price $1,256.00 USDRegular priceUnit price / per -
FDA 510(k), K221241, DrAid for Radiology v1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222658, Accurate 24 Non-invasive blood pressure monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222839, EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223209, Elekta Unity
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223299, Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223517, Clear Aligner
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223609, RevCore™ Thrombectomy Catheter.
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223893, Infrared Heat (Model: E0221)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K230214, Huma RPM (RPM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K230632, VersiHD with GuideMe software
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K230775, SOFIA EX Intracranial Support Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K230857, TiLink-P SI Joint Fusion System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K231168, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K231583, Route 92 Medical Full Length 054 Access System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K231820, SoloSmart Injection Pen Adapter (SoloSmart®)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K232809, Cross Vascular RF Generator and Footswitch (optional accessory)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K780082, PERITONEAL DIALYSIS ADMIN. SET
Regular price $149.00 USDRegular priceUnit price / per