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), K173730, Kinsa QuickCare Thermometer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161579, Watch-PAT200U
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042916, WATCH PAT 100S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190268, Hydrofera Blue READY - Border
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182766, Cufitec Surgical Mask
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K882980, REBUILDER BUCKET SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081467, EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K820723, KODAK EKTACHEM CLINICAL CHEM. NH3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163026, Ultra/Phonic Scanning Gel
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212659, More-Cell-System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041244, POLYGRAM NET BIOFEEDBACK APPLICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213622, Cionic Neural Sleeve NS-100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200667, EyeArt
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200422, Image Quality Analyzer (IQA)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111943, AGILLS PF DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072883, ICE-SENSE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171626, truFreeze System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191412, VariAx 2 System, VariAx 2 Mini Fragment System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171651, EXCELSIUS GPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163221, Mazor X
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152723, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181974, MyoSure XL Tissue Removal Device for Fluent
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172566, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100763, MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101123, NEXFIN MODEL 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101600, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101681, TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101692, PATIENT MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100055, BLOOD PRESSURE METER, MODEL CH-609
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173739, ALOKA ARIETTA 850
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171708, ALOKA ARIETTA 850
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211678, Lunit INSIGHT MMG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171332, Artemis Neuro Evacuation Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190719, Artemis Eye System
Regular price $149.00 USDRegular priceUnit price / per