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), K161324, Raycell Mk2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023892, MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K946357, COLLAGEN INTRACANALICULAR PLUG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151692, BioArchitects Patient Specific Cranial/Craniofacial Plate
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120956, VSP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133907, VSP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050516, T-SLING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121447, ISCHEMA VIEW RAPID
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K904987, VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K971167, NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K962319, NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K922117, C-TRAK BIOPSY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K925167, MASS SPECTROMETRY MONITORING LINE CONONECTORS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120033, ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070136, AUDICOR 200 SYSTEM, MODELS 200D AND 200S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150891, BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163058, Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050574, AFINION HBALC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974520, SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090092, SOCKIT! AND MCMERLIN DERMAL WOUND GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K800494, NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K802123, MONOSPHERICAL SHOULDER PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121735, FIBER DISK AND BLOCK PERMANENT, TRINIA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010156, SLEEP PAT 200 DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001582, LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133560, ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053055, ORTHODONTIC POLYMER COMPOSITE BRACKET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131979, PROVANT THERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091791, PROVANT SYSTEM, MODEL 4201
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972093, REGENESIS MODEL 42
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112605, SYSMEX XN-SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153502, ClariVein IC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051967, REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132261, DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050898, SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981262, CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per