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), K012868, MICROMEDICS FIBRIJET AEROSOL APPLICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K832731, BREAST & BODY HEALTH SYSTEM 2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K851034, NOVATHERM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K872962, BREAST-SCAN(TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122501, AEI DR. TERAUCHI ULTRASONIC TIPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133443, MARATHON NO STING LIQUID SKIN PROTECTANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K911296, OPTICAL CATHETER ARTHROSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992621, ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140750, SHILLA GROWTH GUIDANCE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K792445, MW STRAIGHT ATTACHMENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K800735, U-STYLE ADAPTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163271, i-Stat Alinity System with i-Stat Glucose test
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153357, i-STAT Alinity System with i-STAT Sodium test
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163342, i-STAT Hematocrit test with i-STAT Alinity System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071538, ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140310, Peristeen Anal Irrigation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002431, ELRAN 01 SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021837, BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060832, RETRO-TECH DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K905685, ZENITH COX FLEXION CHIROPRACTIC TABLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043296, COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061735, INFIBRA, MODEL 1200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052698, MODIFICATION TO: AURORA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091321, OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K951355, LINK SADDLE PROTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K943277, LINK SADDLE PROTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983035, CUSTOM FLANGED ACETABULAR COMPONENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982597, FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110599, AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030941, AEQUALIS REVERSED SHOULDER PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060804, COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050177, COLACTIVE COLLAGEN WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112314, NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K905164, TUBE DECLOGGER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162771, EkoSonic Endovascular System with Control Unit 4.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041007, MILLENIUM, MODELS 2000, 2001 AND 2002
Regular price $149.00 USDRegular priceUnit price / per