Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
168649–168672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1979
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININE
K792404 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · JFH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI SERUM IRON
K792406 · CFM
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID
K792412 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ALKALINE PHOSPHATATASE
K792413 · CJE
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TRIGLYCERIDE
K792414 · JGY
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · CIG
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL PROTEINS
K792416 · CER
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI BLOOD UREA NITROGEN
K792417 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
HIM TEST COCAINE
K792429 · DLN
Tecknam, Inc.
Toxicology · 9d
Cleared Dec 06, 1979
PERITONEAL DIALYSIS CYCLER MODEL PDC1000
K791676 · KPF
J.M. Sounds Electronics Co.
Gastroenterology & Urology · 101d
Cleared Dec 06, 1979
FERRITIN RIA KIT
K791860 · DBF
Cis Radiopharmaceuticals, Inc.
Immunology · 78d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
BROWNE MODEL UD-4
K792090 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4D
K792091 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4E
K792092 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL GD-5
K792093 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UA-6
K792094 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
ARM SHIELD FOR ANESTHESIA
K792147 · BTX
Medical Innovations Corp.
General & Plastic Surgery · 45d
Cleared Dec 06, 1979
MODEL 808 ADAPTER
K792150 · GEI
Malibu Laboratories
General & Plastic Surgery · 45d
Cleared Dec 06, 1979
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · FDF
American Optical Corp.
Gastroenterology & Urology · 38d
Cleared Dec 06, 1979
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 35d