FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161545–161568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 29, 1981
DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K813217 · JAA
Diasonics, Inc.
Radiology · 50d
Cleared Dec 29, 1981
MODEL 4200 ELLESTAD STRESS TEST ANALYZER
K813222 · DXG
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 29, 1981
AFTERLOADING GYNECOLOGICAL APPLICATOR
K813230 · IWJ
Esi
Radiology · 49d
Cleared Dec 29, 1981
O'CONNOR HOOK PUNCH FORCEP
K813245 · GEN
Shutt Instruments
General & Plastic Surgery · 41d
Cleared Dec 29, 1981
TEMPERATURE PROBES
K813271 · KRI
Webster Laboratories, Inc.
Cardiovascular · 39d
Cleared Dec 29, 1981
VENOUS CANNULA TRAY
K813284 · DWS
Cunningham Woodland, Inc.
Cardiovascular · 36d