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

Filters: Cleared only ×
176,076 results
162385–162408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1981
CENTIDISC
K813524 · JQC
Bel-Art Products
Chemistry · 15d
Cleared Dec 31, 1981
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY
K813525 · JLW
Micromedic Systems
Chemistry · 15d
Cleared Dec 31, 1981
DADE COLORIMETRIC AMYLASE
K813529 · CIJ
American Dade
Chemistry · 14d
Cleared Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
K813536 · CEK
Hi Chem, Inc.
Chemistry · 13d
Cleared Dec 31, 1981
PHENYTOIN FLUORESCENT IMMUNOASSAY
K813538 · LES
American Diagnostic Corp.
Toxicology · 10d
Cleared Dec 31, 1981
GENTAMICIN FLUORESCENT IMMUNOASSAY
K813539 · LCQ
American Diagnostic Corp.
Toxicology · 10d
Cleared Dec 31, 1981
A FLUOROMETER
K813540 · KHO
American Diagnostic Corp.
Chemistry · 10d
Cleared Dec 30, 1981
VS600 JET VENTILATOR
K812016 · CBK
Instrument Development Corp.
Anesthesiology · 166d
Cleared Dec 30, 1981
BBL DIRECTIGEN TEST KIT
K812808 · GTY
Bd Becton Dickinson Vacutainer...
Microbiology · 85d
Cleared Dec 30, 1981
COATEST ANTITHROMBIN
K812829 · JBQ
Kabivitrum, Inc.
Hematology · 83d
Cleared Dec 30, 1981
125I FERRITIN RADIOIMMUNOASSAY KIT
K812901 · DBF
Bio-Ria
Chemistry · 75d
Cleared Dec 30, 1981
VACU-FIL TRANSFER SET
K812928 · LHI
American Pharmaseal Div. Ahsc
General Hospital · 72d
Cleared Dec 29, 1981
KANTRON 504 HEARTSTATION
K812586 · LDD
Kantron Cardiovascular, Inc.
Cardiovascular · 109d
Cleared Dec 29, 1981
VITALOG PMS-8 MONITOR
K812739 · DQK
Vitalog Corp.
Cardiovascular · 91d
Cleared Dec 29, 1981
SBP-16 CLINIC MUSCLE STIMULATOR
K812851 · IPF
Southwestern Bio-Physical Corp.
Physical Medicine · 77d
Cleared Dec 29, 1981
MICRO-PREPROCESSOR UNIT
K812914 · DSI
General Electric Co.
Cardiovascular · 71d
Cleared Dec 29, 1981
EAST WATER UNIT MARK 3
K812955 · DWJ
Cairco , Ltd.
Cardiovascular · 69d
Cleared Dec 29, 1981
CARDIOINTEGRAM
K812971 · DXG
Ocg Technology, Inc.
Cardiovascular · 68d
Cleared Dec 29, 1981
TELEMETRY TRANSMITTER & RECEIVER
K813064 · DRG
Honeywell, Inc.
Cardiovascular · 60d
Cleared Dec 29, 1981
HISTOCAN BIOPSY NEEDLE
K813081
Burron Medical Products, Inc.
General & Plastic Surgery · 57d
Cleared Dec 29, 1981
SUCTION CATHETER
K813163 · BSY
Northern Medical Industries
Anesthesiology · 49d
Cleared Dec 29, 1981
GEL ELECTRODE
K813176 · DRX
Dyn-A-Med Products
Cardiovascular · 47d
Cleared Dec 29, 1981
MEDIFIX GRADUATED SCALE
K813195 · KRK
Burron Medical Products, Inc.
Cardiovascular · 47d
Cleared Dec 29, 1981
IMAGE ANALYSIS CENTER
K813196 · JAK
Technicare Corp.
Radiology · 47d