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Available for immediate download.
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FDA 510(k), K142881, DMRC Dual Cure Orthodontic Band Cement
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K142889, Celerity PICC Tip Confirmation System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K142900, Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
Regular price $170.23 USDRegular priceUnit price / perSale price $170.23 USD -
FDA 510(k), K142922, SpyGlass DS Direct Visualization System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K142932, Deltex Medical KDP72 Doppler Probe
Regular price $969.46 USDRegular priceUnit price / perSale price $969.46 USD -
FDA 510(k), K142940, Endoskeleton TCS System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K142971, AMT Bridle - Nasal Tube Retention System
Regular price $568.85 USDRegular priceUnit price / perSale price $568.85 USD -
FDA 510(k), K142973, Resolution Clip
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143014, F5
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143054, Sherpa Pak Kidney Transport System
Regular price $510.43 USDRegular priceUnit price / perSale price $510.43 USD -
FDA 510(k), K143067, Carnation Ambulatory Monitor
Regular price $241.73 USDRegular priceUnit price / perSale price $241.73 USD -
FDA 510(k), K143120, OrthoPulse
Regular price $415.84 USDRegular priceUnit price / perSale price $415.84 USD -
FDA 510(k), K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143182, Speedicath Compact Male
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143191, IntelliSense Drill
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143218, Penumbra Smart Coil
Regular price $564.68 USDRegular priceUnit price / perSale price $564.68 USD -
FDA 510(k), K143233, Mitsar-EEG
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143238, C3 Wave
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143263, Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143275, IOLMaster700
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143306, ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143386, Progrip Laparoscopic Self-Fixating Mesh
Regular price $367.15 USDRegular priceUnit price / perSale price $367.15 USD -
FDA 510(k), K143462, AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143496, Piccolo Composite Plate System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143499, eCligner
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143513, ZIO SR ECG Monitoring Service
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Regular price $1,441.01 USDRegular priceUnit price / perSale price $1,441.01 USD -
FDA 510(k), K143541, Relieva SpinPlus Balloon Sinuplasty System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143563, Infusion Aspiration Catheter System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143617, AquaC UNO H
Regular price $615.06 USDRegular priceUnit price / perSale price $615.06 USD -
FDA 510(k), K143646, MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143700, CPAP Cannulaide
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143705, NeedleCam HD Visualization System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K143714, Powerheart G5 AED
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K150041, CORA (Coagulation Resonance Analysis) System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD