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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143329–143352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
V-TREND QC TDM CONTROL SERUM 1,2,3.
K862817 · DIF
Texas Immunology, Inc.
Toxicology · 26d
Cleared Aug 19, 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862818 · JJE
American Dade
Chemistry · 26d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
K862871 · CGR
Cambridge Medical Technology
Chemistry · 21d
Cleared Aug 19, 1986
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · KNX
Hollister, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 19, 1986
ICON READER
K862956 · JQT
Hybritech, Inc.
Chemistry · 14d
Cleared Aug 19, 1986
ANTIASTHMATIC CALIBRATORS
K862964 · DLJ
American Monitor Corp.
Toxicology · 13d
Cleared Aug 19, 1986
ASTRA 2,3,4 AND 6: CHIP REVISION
K863000
Cardiac Pacemakers, Inc.
Cardiovascular · 11d
Cleared Aug 19, 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Aug 19, 1986
CERVICAL SCRAPERS
K863145 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 4d
Cleared Aug 18, 1986
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
K854845 · DSY
Intervascular, Inc.
Cardiovascular · 257d
Cleared Aug 18, 1986
TM-3400, NOMAD (MODIFIED)
K860968 · GWF
Tracor Northern, Inc.
Neurology · 160d
Cleared Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · DXG
Gould, Inc.
Cardiovascular · 147d
Cleared Aug 18, 1986
EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML
K861494 · KNT
Polymer Technologies
Gastroenterology & Urology · 118d
Cleared Aug 18, 1986
LOPEZ VALVE
K861586 · MJF
Icu Medical, Inc.
General Hospital · 111d
Cleared Aug 18, 1986
OSC-80 OXIMETER
K862161 · DQA
Waters Instruments, Inc.
Anesthesiology · 73d
Cleared Aug 18, 1986
SONORANGER
K862166 · IYO
Ausonics Pty , Ltd.
Radiology · 70d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202 · KHG
Abbott Laboratories
Hematology · 69d
Cleared Aug 18, 1986
ESPE VISIO-MOLAR
K862292 · EBF
Espe GmbH (Us)
Dental · 62d
Cleared Aug 18, 1986
ULTRAPAC II SD (TM)
K862337 · GZJ
Medical Devices, Inc.
Neurology · 59d