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), K981730, DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974479, SILIMED VAGINAL STENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981916, LIGASURE VESSEL SEALING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982412, MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983406, SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983517, SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983210, ALGISITE M
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983454, PAIN CARE 2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984167, SAGE 7
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982385, POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984053, BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984638, PARAGON BOLUS ACCESSORY SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984146, PARAGON INFUSION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984443, ORBSCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990184, AUTOMARQER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983483, VASCULAR OCCLUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990328, DBC, DONG BANG ACUPUNCTURE NEEDLES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990560, LIFE IMAGING SYSTEMS, MODEL L3DI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K991642, EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990470, JMS A. V. FISTULA NEEDLE SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992379, RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992693, RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990276, POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K991543, INTRAOP CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992969, RESPIRONICS TOTAL FACE MASK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992833, VACUUM ASSIST STABILIZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K991786, MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992832, SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992341, CIDEX OPA SOLUTION TEST STRIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992209, CUSTODIOL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K993900, COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000365, ACCU-CHEK ADVANTAGE METER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000080, ASNIS III CANNULATED SCREW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000281, WALLSTENT ENTERNAL PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
Regular price $149.00 USDRegular priceUnit price / per