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
152473–152496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · CKA
Sigma Chemical Co.
Chemistry · 41d
Cleared Aug 12, 1984
SOPHEIA/MP DIGITOXIN EIA KIT
K842578 · LFM
Diagnostic Products Corp.
Toxicology · 40d
Cleared Aug 12, 1984
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · JFL
Shaban Mfg. Co.
Chemistry · 33d
Cleared Aug 12, 1984
EMIT LOW & MEDIUM CALIBRATORS A
K842673
Syva Co.
Toxicology · 33d
Cleared Aug 12, 1984
NEW METHYLENE BLUE N
K842743 · KFC
E K Ind., Inc.
Hematology · 30d
Cleared Aug 12, 1984
WRIGHT STAIN
K842744 · IAF
E K Ind., Inc.
Pathology · 30d
Cleared Aug 12, 1984
LACTALBUMIN HYDROLYSATE MED. CATALOG
K843045 · KIT
Sigma Chemical Co.
Chemistry · 10d
Cleared Aug 10, 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
K834429 · LIT
American Edwards Laboratories
Cardiovascular · 239d
Cleared Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
K840903 · KHE
Helena Laboratories
Hematology · 164d
Cleared Aug 10, 1984
ESCHWEILER COMBI-ANALYSER MTA-500
K840961 · CEM
U.S. Science, Inc.
Chemistry · 157d
Cleared Aug 10, 1984
COMPUTER, CENTRAL PROCESSING UNIT
K841261 · DXG
Nem Computer Corp.
Cardiovascular · 137d
Cleared Aug 10, 1984
MULTIPRO CATHETER
K841797 · DQY
Shiley, Inc.
Cardiovascular · 109d
Cleared Aug 10, 1984
TISSUE INTEGRATED PROSTHESIS DRILL
K841813 · ERL
Bofors Nobelpharma, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 10, 1984
DCX-100 CHEST UNIT-GL-5000M
K841923 · KPR
Transworld X-Ray Corp.
Radiology · 92d
Cleared Aug 10, 1984
RADIOEAR M420H
K841933 · ESD
Radioear Corp.
Ear, Nose, Throat · 91d
Cleared Aug 10, 1984
SARNS EVACUPLEGE CATHETER
K842044 · DWE
3M Health Care, Sarns
Cardiovascular · 81d
Cleared Aug 10, 1984
TOYO JOZO G-GTP TEST
K842104 · JPZ
Advocacy International, Ltd.
Chemistry · 77d
Cleared Aug 10, 1984
LEE BONE MARROW NEEDLES
K842106 · GAA
Southland Instruments, Inc.
General & Plastic Surgery · 77d
Cleared Aug 10, 1984
DMI ASPIRATOR 500
K842204 · BTA
Dean Medical Instruments, Inc.
General & Plastic Surgery · 67d
Cleared Aug 10, 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · DWF
Dlp, Inc.
Cardiovascular · 53d
Cleared Aug 10, 1984
ELECTRO-SAGE MODEL 203
K842379 · IRO
Weingart, Inc.
Physical Medicine · 53d
Cleared Aug 10, 1984
3M RAPIDSTAT LIGATING CLIP SYS
K842382 · FZP
3M Company
General & Plastic Surgery · 53d
Cleared Aug 10, 1984
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
K842482 · CEC
Amersham Corp.
Chemistry · 46d
Cleared Aug 10, 1984
OPTICLEAR
K842485 · JJN
Gelman Sciences, Inc.
Chemistry · 46d