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
160441–160464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1982
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
K820666 · JKD
Immuno Nuclear Corp.
Chemistry · 124d
Cleared Jul 13, 1982
BIOMEDICAL FLUOROPTIC
K821070 · FLL
Luxtron
General Hospital · 88d
Cleared Jul 13, 1982
ALBUMIN REAGENT SET
K821193 · CIX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CHOLESTEROL REAGENT SET
K821195 · CHD
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM CALCIUM REAGENT SET
K821196 · CIC
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · CIG
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
K821198 · CGE
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CREATININE REAGENT SET
K821199 · CGX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
K821200 · CIO
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
HDL PRECIPITANT REAGENT SET
K821203 · LBR
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
K821210 · CEK
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
URIC ACID REAGENT SET
K821213 · CDH
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
GEMSTAR SYSTEM
K821335 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 69d
Cleared Jul 13, 1982
LEVEL I LIPID CONTROL
K821559 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
LEVEL II LIPID CONTROL
K821560 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
RIAGEN B-HCG RIA
K821657 · JHI
Biogenex Laboratories
Immunology · 39d
Cleared Jul 13, 1982
PP-100, PERSONAL PERINEOMETER
K821664 · HIR
Farrall Instruments, Inc.
Gastroenterology & Urology · 46d
Cleared Jul 13, 1982
PASSIVE HEAT PADS
K821692 · IRT
Biotone International, Inc.
Physical Medicine · 35d
Cleared Jul 13, 1982
CLINICAL DATA APNEA DETECTOR
K821721 · FLS
Clinical Data, Inc.
Anesthesiology · 33d
Cleared Jul 13, 1982
HEALTHDYNE MODEL 16900 INFANT MONITOR
K821731 · BZQ
Healthdyne, Inc.
Anesthesiology · 42d
Cleared Jul 13, 1982
82 ALLOY
K821798 · EJS
J. Aderer, Inc.
Dental · 25d
Cleared Jul 13, 1982
MCSC6PS MEDICAL COMPONENTS
K821820 · LFL
Medical Components, Inc.
General & Plastic Surgery · 22d
Cleared Jul 13, 1982
A O HISTOSTAT EMBEDDING CTR #8030,32,34
K821831 · IDS
Warner-Lambert Co.
Pathology · 21d
Cleared Jul 13, 1982
THIOGLYCOLLATE MED. W/VITAMIN K-1
K821864 · JSC
Granite Diagnostics, Inc.
Microbiology · 19d