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
160225–160248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1982
ML-810 CARBON DIOXIDE LASER SYSTEM
K827442
Merrimack Laboratories
Radiology · 33d
Cleared May 19, 1982
BSINUS DIAPHANOGRAPH
K827448
Sinus Medical, Inc.
Radiology · 27d
Cleared May 19, 1982
SIMPLAMATIC III
K827450
Spectrum X-Ray Corp.
Radiology · 22d
Cleared May 18, 1982
SC-2500F CARDIOTOMY RESERVIOR
K813268 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 179d
Cleared May 18, 1982
LIXISCOPE - OR LIXI
K820658 · OXO
Lixi, Inc.
Radiology · 69d
Cleared May 18, 1982
PRESSURE-STAT
K820667 · DXN
Alvin H. Sacks, Ph.D.
Cardiovascular · 68d
Cleared May 18, 1982
MEMOPORT C
K820881 · DSI
Litton Medical Electronics
Cardiovascular · 49d
Cleared May 18, 1982
PMS-2 PRESSURE MONITOR SEPARATOR
K820912 · DXS
Delta Medical Industries
Cardiovascular · 47d
Cleared May 18, 1982
FLOW DIRECTED THERMAL-DILUTION CATHETER
K821056
Oximetrix, Inc.
Cardiovascular · 33d
Cleared May 18, 1982
FLOW DIRECTED THERMAL-DILUTION INFUSION
K821057 · DYG
Oximetrix, Inc.
Cardiovascular · 32d
Cleared May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821099 · DYG
Kma, Inc.
Cardiovascular · 28d
Cleared May 18, 1982
AIRLIFE NEBULIZER HEATER
K821129 · CAF
Airlife, Inc.
Anesthesiology · 28d
Cleared May 18, 1982
MEDITRACE PELLET ELECTRODE
K821137 · DRX
Graphic Controls Corp.
Cardiovascular · 28d
Cleared May 18, 1982
SUBMISSION CORONARY CANNULA
K821149 · DWF
Dlp, Inc.
Cardiovascular · 25d
Cleared May 18, 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 21d
Cleared May 18, 1982
EVENTMASTER 3 HOLTER EVENT SCANNER
K821173 · DSF
Instruments For Cardiac Research
Cardiovascular · 22d
Cleared May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821235 · DYG
Gould, Inc.
Cardiovascular · 20d
Cleared May 18, 1982
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · KPO
Erika, Inc.
Hematology · 14d
Cleared May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
K820296 · DIF
American Dade
Chemistry · 99d
Cleared May 14, 1982
VD ALERT
K820520 · LIO
Intl. Research Distributors, Inc.
Microbiology · 77d
Cleared May 14, 1982
MECRON(R) ACETABULAR NETS TM
K820619 · FTM
Serrano Intl.
General & Plastic Surgery · 67d
Cleared May 14, 1982
VEIN-SHIELD
K820759 · KMK
Pan-Tech Research, Inc.
General Hospital · 53d
Cleared May 14, 1982
8700 CLINICAL CHEM. ANALYZER
K820888 · JJE
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared May 14, 1982
MECRON VOORHOEVE TITANIUM SHEATH
K820899
Serrano Intl.
Orthopedic · 44d