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
173761–173784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · CDW
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CHOLESTEROL REAGENT
K771313 · CGO
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (O-TOLUIDINE)
K771314 · CGE
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
HYDRON BURN BANDAGE
K771321 · KMF
Abbott Laboratories
General & Plastic Surgery · 16d
Cleared Aug 03, 1977
UVIOBOND
K771328 · KLE
Espe GmbH (Us)
Dental · 16d
Cleared Aug 03, 1977
CREATININE ANALYZER 2
K771335 · CGX
Beckman Instruments, Inc.
Chemistry · 16d
Cleared Aug 03, 1977
R&R ALSTON CARBIDE BURS
K771347 · EJL
Ransom and Randolph
Dental · 14d
Cleared Aug 03, 1977
INTERPLANTS
K771366 · DZE
Maurices J. Fagan, Jr. B.S., D.D.S.
Dental · 9d
Cleared Aug 03, 1977
ICROTAINEO BRAND TUBE
K771370 · GJE
Bd Becton Dickinson Vacutainer...
Hematology · 9d
Cleared Aug 03, 1977
FETAL MONITORING SYS. MODEL FM3R
K771379 · HGM
Sonicaid, Inc.
Obstetrics & Gynecology · 8d
Cleared Aug 03, 1977
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · EJJ
Johnson & Johnson Professionals, Inc.
Dental · 7d
Cleared Aug 03, 1977
DISPENSER, MERCURY & TABLET/POWDER
K771396 · EHE
Johnson & Johnson Professionals, Inc.
Dental · 6d
Cleared Aug 03, 1977
NUVA-FIL COMPOSITE RESTORATIVE (MODI.)
K771404 · EBF
L.D. Caulk Co.
Dental · 5d
Cleared Aug 02, 1977
WHOLE BLOOD GAS CONTROL
K770950 · JJS
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 69d
Cleared Aug 02, 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991 · CKA
Macomb Chemical Co.
Chemistry · 62d
Cleared Aug 02, 1977
POLYURETHANE PROD. FOR I.V. NEEDLES
K771125 · FPX
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Aug 02, 1977
MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV
K771156 · KIE
The Perkin-Elmer Corp.
Toxicology · 35d
Cleared Aug 02, 1977
RESUSCITATOR, MS30
K771175 · BTM
Mckesson Corp.
Anesthesiology · 34d
Cleared Aug 02, 1977
LUMI-AGGREGOMETER
K771198 · JBY
Chrono-Log Corp.
Hematology · 32d
Cleared Aug 02, 1977
AK-10
K771227 · FIL
Gambro, Inc.
Gastroenterology & Urology · 26d
Cleared Aug 02, 1977
LIFECARE EMPTY CONTAINER
K771228 · KPE
Abbott Laboratories
General Hospital · 26d
Cleared Aug 02, 1977
STERILIZERS, 3100 SERIES TRIM LINE
K771229 · FLE
Castle Co.
General Hospital · 26d
Cleared Aug 02, 1977
NERVE STIMULATORS
K771237 · BXN
Rule Medical Instruments, Inc.
Anesthesiology · 22d
Cleared Aug 02, 1977
GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM
K771239
G.D. Searle and Co.
Immunology · 22d