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), K123300, BD PEN NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131158, CORVIEW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143536, Voyant Fine Fusion Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132612, HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974280, ABUTMENT - COMPLETE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961381, KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961382, MT1A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143022, BioHorizons Tapered Internal Implants
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100985, BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093321, BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120949, INFRASCANNER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133987, CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111680, DR. GREENSBURG'S HYBRID
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120371, DR GREENBURGS HYBRID ACRYLIC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120372, DR GREENBURGS HYBRID VACUUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143189, t:flex Insulin Delivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120296, CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122462, ROTH NET RETRIEVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132031, AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122538, ACUMED PELVIC BONE PLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123546, 3M ATTEST(TM) AUTO-READER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091935, LIPIVIEW OCULAR SURFACE INTERFEROMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140929, Z1 CPAP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K955841, SLEEP SYSTEM FOR CLINICS & RESEARCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142988, Sleepware G3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140575, ENGSTROM CARESTATION, ENGSTROM PRO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133355, CADWELL FLEX EEG/PSG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101786, ADVANIX DOUBLE PIGTAIL BILIARY STENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101314, ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092910, FLUID-FILLED TEETHER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131973, UNEXEF-38G ULTRASOUND SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130978, ZTX ULTRASONIC DIATHERMY DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142024, BRIGHTMATTER NAVIGATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141139, SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131287, CARDIOSLEEVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070793, SBI DISTAL RADIUS VOLAR PLATING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per