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
154249–154272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1984
CHOLESTEROL AQUEOUS STANDARD
K840217 · JIS
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
TRIGLYCERIDE AQUEOUS STANDARDS
K840218 · JIT
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
TRIGLYCERIDE/CHOLESTEROL AQUEOUS
K840219 · JIX
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
HDL CHOLESTEROL AQUEOUS STANDARDS
K840220 · JIS
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
UROLIX-3 UROLOGICAL TABLE
K840227 · IXR
Medicor USA , Ltd.
Radiology · 64d
Cleared Mar 23, 1984
FSH QUIK RIA KIT
K840230 · CGJ
Pacific Biotech, Inc.
Chemistry · 63d
Cleared Mar 23, 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · DKJ
Sigma Chemical Co.
Chemistry · 63d
Cleared Mar 23, 1984
HDL CHOLESTEROL CONTROLS-LEVELS
K840278 · JIX
Preventive Diagnostics Corp.
Chemistry · 60d
Cleared Mar 23, 1984
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
K840299 · JIS
Bionostics, Inc.
Chemistry · 59d
Cleared Mar 23, 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300 · CHL
Bionostics, Inc.
Chemistry · 59d
Cleared Mar 23, 1984
CHEM-STAT ANALYZER
K840340 · JJQ
Ocean Scientific, Inc.
Chemistry · 58d
Cleared Mar 23, 1984
EMIT ST SERUM ETHYL ALCOHOL ASSAY
K840400 · DML
Syva Co.
Toxicology · 53d
Cleared Mar 23, 1984
HEXCELITE
K840416 · ITG
Hexcel Medical
Physical Medicine · 52d
Cleared Mar 23, 1984
HARRINGTON-TYPE INSTRU-SCOLIOSIS
K840423 · KWP
Link America, Inc.
Orthopedic · 52d
Cleared Mar 23, 1984
AMICON DIAFILTER 40. HEMOFILTER
K840449 · KDI
Medical Device Consultants, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 23, 1984
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454 · LBI
Air-Shields, Inc.
General Hospital · 60d
Cleared Mar 23, 1984
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
K840461 · DON
Corning Medical & Scientific
Toxicology · 50d
Cleared Mar 23, 1984
SDL LISTERIA MONOCYTOGENES CONTROL
K840503 · GSI
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENINGITIDES GR. 2
K840504 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENNINGITIDIS GR. X
K840505 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. Y
K840507 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. C
K840508 · JTO
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. B
K840509 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. A
K840510 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d