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
157537–157560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1983
DIRECTIGEN NEISSERIA MENINGITIDIS
K830646
Bd Becton Dickinson Vacutainer...
Microbiology · 87d
Cleared May 27, 1983
PORTABLE OXYGEN SYSTEM
K830844 · CAN
Puritan Bennett Corp.
Anesthesiology · 71d
Cleared May 27, 1983
STOMACH TUBE
K830985 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
RECTAL TUBES
K830986 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
LEVIN TUBE
K830987 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
REDOX CONTROLLER
K830994 · KDN
St. Louis Univ. Medical Center
Gastroenterology & Urology · 59d
Cleared May 27, 1983
COMPLUS VARIOUS FORMS
K831039
Parker Laboratories, Inc.
Dental · 57d
Cleared May 27, 1983
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · CGR
Syva Co.
Immunology · 50d
Cleared May 27, 1983
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · CJM
Diagnostic Products Corp.
Chemistry · 46d
Cleared May 27, 1983
PREGNA-CERT, SLIDE PREGNANCY TEST
K831180 · JHJ
Diagnostic Specialties
Chemistry · 46d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · DYG
Cook, Inc.
Cardiovascular · 45d
Cleared May 27, 1983
GAS-STAT MONITORING SYSTEM
K831225 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 42d
Cleared May 27, 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · KLS
Syva Co.
Chemistry · 38d
Cleared May 27, 1983
LIQUI-SERA ANTICONVULSANTS CONTROLS
K831278 · DIF
Biodiagnostic Intl
Toxicology · 38d
Cleared May 27, 1983
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · GWQ
Nihon Kohden America, Inc.
Neurology · 32d
Cleared May 27, 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338 · KOC
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared May 27, 1983
FLUID ADMIN. SET AFS-1C
K831348 · DRS
Linton Biomed Corp.
Cardiovascular · 32d
Cleared May 27, 1983
EMIT QST LIDOCAINE ASSAY
K831354 · KLR
Syva Co.
Toxicology · 31d
Cleared May 27, 1983
TESTCORP CRP
K831362 · DCN
Catheter Technology Corp.
Microbiology · 31d
Cleared May 27, 1983
TESTCORP RA
K831364 · DCN
Myo-Tronics Research, Inc.
Microbiology · 31d
Cleared May 27, 1983
LATEX URINARY CATHETERS
K831369 · KOD
Wayne Surgical Products
Gastroenterology & Urology · 31d
Cleared May 25, 1983
MYCOPLASMELISA TEST KIT
K823804 · LJZ
M.A. Bioproducts
Microbiology · 159d
Cleared May 25, 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904 · DRT
Ge Medical Systems Information...
Cardiovascular · 148d
Cleared May 25, 1983
BERA SH 221 BRIAN STEM AUDIOMETER
K830173 · GNJ
Jedmed Instrument Co.
Microbiology · 127d