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
Can't find what you are looking for? Submit a Custom Request.
-
FDA 510(k), K182540, DiLumen Endolumenal Interventional Platform
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193659, iTero Element 5D
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160944, ACCU-CHEK Guide Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181131, Accu-Chek Guide Me Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K901040, IONOMETER EH-F AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K964630, GLUCOMETER ELITE BLOOD GLUCOSE METER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051187, REXEED SERIES DIALYZERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001852, PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112822, SLEEPSTRIP II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191031, NightOwl
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110653, CURE CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080881, CURE CATHETER CLOSED SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132500, CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072539, CURE CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212725, ViperCross Support Catheters
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193420, XO Cross Support Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033120, SCALETRON PIEZO ULTRASOUND SCALER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130672, OPTIFLOW II FLOWABLE COMPOSITE, LC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141422, PROFLUORO FLUORIDE VARNISH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141717, PACSEAL PIT & FISSURE SEALANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151150, Elements
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151852, PacEndo Sodium Hyprochlorite
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153528, PacEndo EDTA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160577, PacEndo Chlorhexidine
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162662, GingiDent Gingival Retraction Paste
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200330, RC-Prime Root Canal Preparation Cream
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202831, The iMask Child's Face Mask
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030603, PROANGLE DISPOSABLE PROPHY ANGLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203434, BlueStar Rx
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183048, Quantisal II Oral Fluid Collection Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201634, RG 3ml Medication Cartridge
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110424, DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173119, DRI OCT Triton
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070296, VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203641, E-Denture Pro
Regular price $149.00 USDRegular priceUnit price / per