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), K191363, Neocis Planning Software Application (NPSA) for 3rd Party PCs
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182776, Neocis Guidance System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173402, Neocis Guidance System (NGS) with Chairside Splint
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K170435, NerveGuard NRFit, NerveGuard LUER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K872510, DEN-MAT TENURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153193, Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210561, Advisor Pro Platform
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150781, Tissue Removal Pouch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151990, Tissue Removal System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003064, TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895562, PEMACO 2000 INTRAORAL DENTAL WAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895563, PEMACO BITE WAX SHEETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895564, PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895565, PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895566, PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910676, INTRAORAL DENTAL WAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895561, PEMACO 3000 INTRAORAL DENTAL WAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203040, TSolution One Total Knee Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172735, WR19 System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171565, OEC Elite
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132904, ZIEHM VISION RFD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K925080, TEK-LUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182325, InMode RF System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163190, InMode RF System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151793, InMode RF System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171593, InMode RF System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K832654, HEATED GUTTA PERCHA DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042828, OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201220, Aerus Medical Guardian,model F170A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981095, ALIGN SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210805, Ceribell Instant EEG Headband
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974793, ELMED ESU 120 M/M DIGITAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961100, MICRO ANASTOMOSIS CLAMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982278, MICRINS MICRO ANASTOMOSIS CLAMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161315, Vein Clamps, Artery Clamps
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011208, BIOVER
Regular price $149.00 USDRegular priceUnit price / per