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

89 results for "American Edwards Laboratories"
1–24 of 89
Search insights Median review: 47d Cleared: 99% Top manufacturer: American Edwards Laboratories Lead specialty: Cardiovascular
Cleared Dec 03, 1987
EDSLAB (R) OCCLUSION BALLOON CATHETER
K873485 · DQY
American Edwards Laboratories
Cardiovascular · 94d
Cleared Sep 30, 1987
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · DRS
American Edwards Laboratories
Cardiovascular · 90d
Cleared Sep 15, 1987
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · DXG
American Edwards Laboratories
Cardiovascular · 81d
Cleared Apr 17, 1987
HOMEPRO II VOLUMETRIC INFUSION PUMP
K870444 · FRN
American Edwards Laboratories
General Hospital · 73d
Cleared Feb 27, 1987
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K864997 · FRN
American Edwards Laboratories
General Hospital · 67d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330 · DXE
American Edwards Laboratories
Cardiovascular · 63d
Cleared Jan 02, 1987
VEIN VALVE CUTTER
K862724 · DQY
American Edwards Laboratories
Cardiovascular · 169d
Cleared Nov 20, 1986
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
K864155 · DTJ
American Edwards Laboratories
Cardiovascular · 28d
Cleared Nov 20, 1986
CHIN-FOGARTY INFLATION DEVICE
K863596 · DXT
American Edwards Laboratories
Cardiovascular · 66d
Cleared Oct 31, 1986
XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
K863986 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Oct 24, 1986
FLEXIBLE VISUALIZATION CATHETER
K862872 · FEI
American Edwards Laboratories
Gastroenterology & Urology · 86d
Cleared Oct 03, 1986
ARTHROSCOPIC IRRIGATION PUMP
K863605 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Oct 03, 1986
DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
K863604
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Oct 02, 1986
VIDEO CAMERA SYSTEM
K863598 · FWF
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
ARTHROSCOPIC SURGICAL POWER DEVICE
K863696 · KIT
American Edwards Laboratories
Pathology · 7d
Cleared Sep 25, 1986
AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
K863597 · HRX
American Edwards Laboratories
Orthopedic · 10d
Cleared Sep 03, 1986
MECHANICAL INFLATION DEVICE
K862547 · DXT
American Edwards Laboratories
Cardiovascular · 62d
Cleared Feb 12, 1986
RATEMINDER III INFUSION DEVICE
K855000 · LDR
American Edwards Laboratories
General Hospital · 61d
Cleared Oct 04, 1985
RIGID ENDOSCOPE
K853514 · GCM
American Edwards Laboratories
Gastroenterology & Urology · 43d
Cleared Aug 23, 1985
TROCAR/CANNULA/SHEATH SET
K853337 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 14d
Cleared Aug 22, 1985
AMERICAN EDWARDS LABORATORIES FLEXISCOPE
K852759 · HRX
American Edwards Laboratories
Orthopedic · 55d
Cleared Aug 21, 1985
URETERAL DILATOR
K852324 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 83d
Cleared Aug 09, 1985
URETERAL DILATOR/SHEATH SET
K852793 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 39d
Cleared Jun 28, 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · HRX
American Edwards Laboratories
Orthopedic · 81d