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
161065–161088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1982
METAL BACKED ACETABULAR COMPONENT
K821342 · JOL
Intermedics Orthopedics
General Hospital · 16d
Cleared May 21, 1982
TITANIUM AUFRANC-TURNER ATS HIP SYS
K821369 · JDI
Howmedica Corp.
Orthopedic · 11d
Cleared May 21, 1982
LIGHT WEIGHT ALUMINUM WALKER
K821404 · ITJ
Manuco Manufacturing Co., Inc.
Physical Medicine · 10d
Cleared May 20, 1982
J.E.T. DIALYSIS SYSTEM
K820575 · FKJ
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 78d
Cleared May 19, 1982
DIAGNOSTIC X-RAY HV GENERATOR
K827378
Technicare Corp.
Radiology · 29d
Cleared May 19, 1982
X-RAY CASSETTE
K827379
Synchroplan Corp.
Radiology · 30d
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