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), K023254, SPEEDICATH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023830, AIROCIDE TI02
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K024071, GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023238, MCPULSE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030311, HEM-O-LOK XL CLIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030289, HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030611, MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030688, ECHELON MICRO CATHETER, MODEL 105-5092-150
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030009, KSEA POWERSHAVER SYSTEM S2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030982, SYNGO COLONOGRAPHY SOFTWARE PACKAGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030940, NOMAD ND1000M AUGMENTED VISION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023872, VITALCARE URETHRAL CATHETER RED RUBBER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030974, EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031011, LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030813, PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030605, RAPID IMF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K024367, SINCLAIR WOUND AND SKIN EMULSION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031759, ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031435, BONESOURCE BVF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031544, HEATER COOLER UNIT, MODEL HCU 30
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032203, HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032163, DURACON TOTAL KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031359, S-MONOVETTE EDTA K2-GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030719, PENTACAM SCHEIMPFLUG CAMERA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032030, BLINK CL LUBRICANT EYE DROPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030886, NICO WITH MARS, MODEL 7300
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032115, NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032482, STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K024322, EMBLA N7000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031838, PROFUSION BONE VOID FILLER KIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032481, THERATEARS CONTACT LENS COMFORT DROPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033275, LIFEPAK 12, 20, 500, CR PLUS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033021, KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033568, GYNECARE TVT OBTURATOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033269, ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032571, IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
Regular price $149.00 USDRegular priceUnit price / per