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
173929–173952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1977
A-GENT ALBUMIN
K770822 · CIX
Abbott Laboratories
Chemistry · 68d
Cleared Jul 11, 1977
SPECTROPHOTOMETERS,34,35,36,3600
K770825
Beckman Instruments, Inc.
Chemistry · 67d
Cleared Jul 11, 1977
PLATELET AGITATOR
K770830 · GLE
Helmer Labs, Inc.
Hematology · 66d
Cleared Jul 11, 1977
STATZYME URIC ACID REAGENT
K770831 · CDO
Worthington Biochemical Corp.
Chemistry · 66d
Cleared Jul 11, 1977
CIRCUMCISION KIT
K770873 · FHG
American Hospital Supply Corp.
Obstetrics & Gynecology · 59d
Cleared Jul 11, 1977
BURN DRESSING KIT
K770889 · EFQ
The Owenby Co.
General & Plastic Surgery · 56d
Cleared Jul 11, 1977
EMATOLOGY DILUENT RESERVOIR CLOSURE
K770980 · GHO
Bd Becton Dickinson Vacutainer...
Hematology · 41d
Cleared Jul 11, 1977
LANCER CAPILLARY BLOOD SERUM SEPARATOR
K770981 · GIO
Sherwood Medical Industries
Hematology · 41d
Cleared Jul 11, 1977
STATZYME GLUCOSE
K771001 · CGA
Worthington Biochemical Corp.
Chemistry · 38d
Cleared Jul 11, 1977
VYGON RED-O-PACK
K771015 · GCY
Coastal Bend Medical Products, Inc.
General & Plastic Surgery · 35d
Cleared Jul 11, 1977
HSV TEST
K771063 · GQL
Gull Laboratories, Inc.
Microbiology · 28d
Cleared Jul 11, 1977
CATHETER, SAMPLING, CONDUIT
K771066 · FEZ
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Jul 11, 1977
UNIPAK HEMOGLOBIN
K771090 · GKK
Harleco
Chemistry · 25d
Cleared Jul 11, 1977
COUNTER 700 & HC-700 HEMO 0 REF.
K771107 · GKL
Hycel, Inc.
Hematology · 21d
Cleared Jul 11, 1977
CENTRIA SEPARATION COLUMNS TYPE A
K771118 · CEM
Clinical Diagnostics, Inc.
Immunology · 20d
Cleared Jul 11, 1977
INORGANIC PHOSPHORUS STANDARDS
K771143 · JIT
Worthington Biochemical Corp.
Hematology · 14d
Cleared Jul 11, 1977
DERMAHOOK #382-805
K771187 · GDG
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
HOT TEMP CAUTERY
K771189 · HQP
Edward Weck, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1977
ABRAMSON TRACHEA HOOK & RETRACTOR
K771190 · GDG
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
HEISS RETRACTOR
K771191 · GAD
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
LOWMAN BONE FORCEP
K771192 · HTD
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
UROGARD URINARY DRAINAGE BAG
K771210 · FCN
Terumo America, Inc.
Gastroenterology & Urology · 6d
Cleared Jul 06, 1977
LABORATORY EXPENDABLE PRODUCTS
K770594 · JRC
Abco Dealers, Inc.
Chemistry · 100d
Cleared Jul 06, 1977
FLUORESCENCE ILLUMINATOR ACCESSORY
K770652 · IBK
Bausch & Lomb, Inc.
Pathology · 91d