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), K200265, Surgical Drills
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090260, MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082532, STRAUMANN GUIDED INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150796, Dental Bone Cutting Instruments
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203695, NObreath®
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090750, RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190285, L300 Go System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181288, Athelas One
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200828, Athelas Home
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111411, FREEMIE (R)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011132, AIRLIFE HEPA FILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130752, DYNASENSE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141877, LEAF PATIENT MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220158, G-EYE System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K945794, DURAPHAT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131487, FLUOR PROTECTOR S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K934073, JEDENTAL GLASS IONOMER CEMENT AND LINER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212835, AquaBeam Robotic System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202961, AquaBeam Robotic System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212470, iRAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163232, Vitrea View
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180141, SPIWay Endonasal Access Guide
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122434, MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172179, Chitogel Endoscopic Sinus Surgery Kit
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072474, QUIKCLOT EX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202830, Axiostat Patch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K951721, APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935189, E-Z DERM BIOSYNTHETIC WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972324, LEKSELL STEREOTACTIC SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080355, LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190887, Leksell Vantage Stereotactic System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212265, TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172452, Bruxor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103783, EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123402, DIAGNOCAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172007, CamX Triton HD Proxi Head
Regular price $149.00 USDRegular priceUnit price / per