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
153985–154008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1984
ISOSTAT MICROBIAL TUBE PROCESSING
K840496 · JKA
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 67d
Cleared Apr 13, 1984
HEMASTAPH
K840553 · JTL
Remel Co.
Microbiology · 65d
Cleared Apr 13, 1984
REX V
K840562 · EJH
Jeneric Ind.
Dental · 65d
Cleared Apr 13, 1984
MULTI-STIMT
K840599 · GZJ
Joanco Medical Electronics , Ltd.
Neurology · 63d
Cleared Apr 13, 1984
LABORIE FIBREOPTIC LIGHT CABLE
K840605 · FFS
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 13, 1984
RIFAMPIN DISC
K840614 · JTO
Remel Co.
Microbiology · 60d
Cleared Apr 13, 1984
HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
K840677 · LBS
Preventive Diagnostics Corp.
Chemistry · 58d
Cleared Apr 13, 1984
2U PENICILLIN DISC
K840686 · JTO
Remel Co.
Microbiology · 58d
Cleared Apr 13, 1984
COLISTIN DISC
K840708 · JTO
Remel Co.
Microbiology · 56d
Cleared Apr 13, 1984
PENTRA-FIL II
K840727 · EBF
Pentron Corp.
Dental · 52d
Cleared Apr 13, 1984
URETERAL DILATOR
K840746 · KOE
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Apr 13, 1984
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · DZE
Calcitek, Inc.
Dental · 50d
Cleared Apr 13, 1984
AMBEZE DISPOSABLE INCONTINENCE PANTS
K840753 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MAXISHIELD INCONTINENCE CARE SYSTEM
K840754 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MINIGARD DISPOSABLE LINERS
K840755 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
PARAMAX ALCOHOL REAGENT
K840769 · DML
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR I
K840771 · JIT
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR II
K840772 · JIT
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
LACTATE REAGENT
K840778 · KHP
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
NEONATAL BILIRUBIN REAGENT
K840779 · CIG
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
URIC ACID REAGENT
K840781 · KNK
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALBUMIN REAGENT
K840782 · CIX
American Dade
Chemistry · 58d
Cleared Apr 13, 1984
PARAMAX MAGNESIUM REAGENT
K840784 · JGJ
American Dade
Chemistry · 58d
Cleared Apr 13, 1984
CK/MB IMMUNO-ISOENZYME CONTROL SERUM
K840793 · JJT
Seragen Diagnostics, Inc.
Chemistry · 50d