Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K160872, PolyPlex Wound Dressing
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071822, URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051672, POWERPICC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053345, PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033389, POWERPICC CATHETERS, MODELS 3175155, 3175135
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162218, Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052241, DISC-FX SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K863547, MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140828, NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160185, Wrist 3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001794, EBI ANTERIOR CERVICAL PLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000742, SYNTHES ANTERIOR CSLP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K893334, PREPOWDERED VINYL EXAM GLOVES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130808, STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161677, Straumann Sterile Healing Solution
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151436, PICO Single Use Negative Pressure Wound Therapy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160618, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093995, IG 4 IMAGE GUIDED SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093146, IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141745, IQQA-BODYIMAGING SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K014156, CERASORB ORTHO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063527, MBCP+
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051774, MBCP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051992, POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141117, EZ-IO INTRAOSSEOUS INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080525, COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052408, EZ-IO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083324, LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K124030, COOK HOLMIUM LASER FIBER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160621, SIGNAPioneer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160184, Voluson S6, Voluson S8, Voluson S10
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160173, Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142688, Echotip Procore HD Ultrasound Biopsy Needle
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981973, SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per