American Edwards Laboratories

FDA Filings

This page includes the latest FDA filings for American Edwards Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K873485 AMERICAN EDWARDS LABORATORIES	EDSLAB (R) OCCLUSION BALLOON CATHETER	1987-12-03
PMN K872596 AMERICAN EDWARDS LABORATORIES	TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30	1987-09-30
PMN K872529 AMERICAN EDWARDS LABORATORIES	THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2	1987-09-15
PMN K870444 AMERICAN EDWARDS LABORATORIES	HOMEPRO II VOLUMETRIC INFUSION PUMP	1987-04-17
PMA P840025S011 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1987-03-17
PMN K864997 AMERICAN EDWARDS LABORATORIES	MEDTRAC VP VOLUMETRIC INFUSION PUMP	1987-02-27
PMN K864330 AMERICAN EDWARDS LABORATORIES	SHEAR FORCE GAUGE	1987-01-06
PMN K862724 AMERICAN EDWARDS LABORATORIES	VEIN VALVE CUTTER	1987-01-02
PMN K864155 AMERICAN EDWARDS LABORATORIES	MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS	1986-11-20
PMN K863596 AMERICAN EDWARDS LABORATORIES	CHIN-FOGARTY INFLATION DEVICE	1986-11-20
PMN K863986 AMERICAN EDWARDS LABORATORIES	XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES	1986-10-31
PMN K862872 AMERICAN EDWARDS LABORATORIES	FLEXIBLE VISUALIZATION CATHETER	1986-10-24
PMA P840025S008 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1986-10-16
PMN K863605 AMERICAN EDWARDS LABORATORIES	ARTHROSCOPIC IRRIGATION PUMP	1986-10-03
PMN K863604 AMERICAN EDWARDS LABORATORIES	DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE	1986-10-03
PMN K863598 AMERICAN EDWARDS LABORATORIES	VIDEO CAMERA SYSTEM	1986-10-02
PMN K863696 AMERICAN EDWARDS LABORATORIES	ARTHROSCOPIC SURGICAL POWER DEVICE	1986-09-29
PMN K863597 AMERICAN EDWARDS LABORATORIES	AMERICAN EDWARDS 4.0 MM ARTHROSCOPE	1986-09-25
PMN K862547 AMERICAN EDWARDS LABORATORIES	MECHANICAL INFLATION DEVICE	1986-09-03
PMA P840025S006 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1986-07-25
PMA P840025S005 AMERICAN EDWARDS LABORATORIES	GARREN{TM}-EDWARDS GASTRIC BUBBLE	1986-05-12
PMN K855000 AMERICAN EDWARDS LABORATORIES	RATEMINDER III INFUSION DEVICE	1986-02-12
PMA P840025S004 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1986-01-23
PMA P840025S003 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1986-01-23
PMA P840025S002 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1986-01-23
PMA P840025S001 AMERICAN EDWARDS LABORATORIES	GARREN GASTRIC BUBBLE	1985-12-18
PMN K853514 AMERICAN EDWARDS LABORATORIES	RIGID ENDOSCOPE	1985-10-04
PMN K853337 AMERICAN EDWARDS LABORATORIES	TROCAR/CANNULA/SHEATH SET	1985-08-23
PMN K852759 AMERICAN EDWARDS LABORATORIES	AMERICAN EDWARDS LABORATORIES FLEXISCOPE	1985-08-22
PMN K852324 AMERICAN EDWARDS LABORATORIES	URETERAL DILATOR	1985-08-21
PMN K852793 AMERICAN EDWARDS LABORATORIES	URETERAL DILATOR/SHEATH SET	1985-08-09
PMN K851374 AMERICAN EDWARDS LABORATORIES	AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE	1985-06-28
PMN K850954 AMERICAN EDWARDS LABORATORIES	URETERAL DILATOR & URETERAL STONE DISLODGER	1985-04-03
PMN K850790 AMERICAN EDWARDS LABORATORIES	DIAFLEX OCCLUSION BALLOON CATHETER	1985-03-25
PMN K841374 AMERICAN EDWARDS LABORATORIES	HOME PRO VOLUMETRIC INFUSION PUMP	1985-02-15
PMN K845048 AMERICAN EDWARDS LABORATORIES	NEPHROSTOMY DRAINAGE CATHETER & STIFFENER	1985-01-15
PMN K845047 AMERICAN EDWARDS LABORATORIES	NEPHROSTOMY GUIDEWIRE SHEATH	1985-01-15
PMN K842105 AMERICAN EDWARDS LABORATORIES	RIGHT VENTRICULAR EJECTION FRACTION-	1985-01-15
PMN K841401 AMERICAN EDWARDS LABORATORIES	SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER	1985-01-14
PMN K844090 AMERICAN EDWARDS LABORATORIES	PERCUTANEOUS NEPHROSTOMY TROCAR SYS	1984-12-05
PMN K842410 AMERICAN EDWARDS LABORATORIES	AMER. EDWARDS LAB FLEXISCOPE	1984-11-05
PMN K833763 AMERICAN EDWARDS LABORATORIES	PERICARDIAL PATCH	1984-11-01
PMN K843274 AMERICAN EDWARDS LABORATORIES	MODULAR VOLUMETRIC INFUSION PUMP SYS	1984-10-19
PMN K842481 AMERICAN EDWARDS LABORATORIES	AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE	1984-10-18
PMN K842639 AMERICAN EDWARDS LABORATORIES	AMER. EDWARDS LAB DIAFLEX URETERAL DILA	1984-10-02
PMN K842632 AMERICAN EDWARDS LABORATORIES	DILATOR/SHEATH SET	1984-10-02
PMN K842206 AMERICAN EDWARDS LABORATORIES	DIAFLEX NEPHROSTOMY BALLOON DILATOR	1984-10-02
PMN K841607 AMERICAN EDWARDS LABORATORIES	AMERICAN EDWARDS LABS FLEXISCOPE	1984-08-18
PMN K842323 AMERICAN EDWARDS LABORATORIES	AMER. EDWARDS LAB FLEXISCOPE OBTURATOR	1984-08-17
PMN K842799 AMERICAN EDWARDS LABORATORIES	PERCUTANEOUS ANGIOSCOPE DELIVERY CATH	1984-08-10
PMN K842798 AMERICAN EDWARDS LABORATORIES	INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH	1984-08-10
PMN K834429 AMERICAN EDWARDS LABORATORIES	PERIPHERAL DILATATION ANGIOPLASTY-CATH	1984-08-10
PMN K841922 AMERICAN EDWARDS LABORATORIES	ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232	1984-07-13
PMN K834547 AMERICAN EDWARDS LABORATORIES	ANGIOSCOPY CATHETER	1984-06-11
PMN K833997 AMERICAN EDWARDS LABORATORIES	CO-SET	1984-04-17
PMN K840746 AMERICAN EDWARDS LABORATORIES	URETERAL DILATOR	1984-04-13
PMN K834459 AMERICAN EDWARDS LABORATORIES	DIAGNOSTIC RADIOLOGY CATHETERS	1984-02-04
PMN K834220 AMERICAN EDWARDS LABORATORIES	HYBRID PERIPHERAL DILATION CATHETER	1984-01-27
PMN K833690 AMERICAN EDWARDS LABORATORIES	COAXIAL BALLOON URETHRAL DILATOR	1983-11-29
PMN K832698 AMERICAN EDWARDS LABORATORIES	ANGIOSCOPY CATHETER	1983-11-03
PMN K832554 AMERICAN EDWARDS LABORATORIES	FOGARTY 6MM SOFTJAW CLIP	1983-09-29
PMN K832474 AMERICAN EDWARDS LABORATORIES	FOGARTY-CHIN PERIPHERAL DILATION CATH	1983-09-29
PMN K831659 AMERICAN EDWARDS LABORATORIES	FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE	1983-08-12
PMN K832323 AMERICAN EDWARDS LABORATORIES	EDSLAB PRESSURE GAUGE	1983-08-11
PMN K831949 AMERICAN EDWARDS LABORATORIES	PROSTHETIC RINGS #4400 MITRAL & 4500	1983-07-29
PMN K831244 AMERICAN EDWARDS LABORATORIES	URETERAL STONE EXTRACTOR CATHETER	1983-06-17
PMN K830892 AMERICAN EDWARDS LABORATORIES	THERMODILUTION CARDIAC OUTPUT COMPUTER-	1983-06-15
PMN K830733 AMERICAN EDWARDS LABORATORIES	FORGARTY CHIN PERIPHERAL INTRAOPERATIVE	1983-04-18
PMN K830734 AMERICAN EDWARDS LABORATORIES	FORGARTY BALLOON CALIBRATOR	1983-04-12
PMN K823243 AMERICAN EDWARDS LABORATORIES	SIDEARM Y-ADAPTOR	1983-01-21
PMN K822723 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ BIPOLAR PACING CATHETER	1982-10-15
PMN K822687 AMERICAN EDWARDS LABORATORIES	REUSABLE FOGARTY FLEXIBLE CALIBRATOR	1982-10-04
PMN K822350 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH	1982-08-24
PMN K813521 AMERICAN EDWARDS LABORATORIES	TRANSLUMINAL BIPOLAR PACING PROBE	1982-03-15
PMN K820222 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ VIP-CATHETER	1982-02-12
PMN K813514 AMERICAN EDWARDS LABORATORIES	EDSLAB CATHETER COVER	1981-12-29
PMN K812935 AMERICAN EDWARDS LABORATORIES	FOGARTY FLEXIBLE PROBE	1981-11-16
PMN K812563 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ & EDSLAB HEPARIN COATED CATH.	1981-09-25
PMN K812021 AMERICAN EDWARDS LABORATORIES	VOLUMETRIC INFUSION PUMP	1981-07-31
PMN K811094 AMERICAN EDWARDS LABORATORIES	CARDIAC 1000 TM	1981-07-28
PMN K811792 AMERICAN EDWARDS LABORATORIES	ARRYTHMIA PRINTER OPTION	1981-07-10
PMN K811254 AMERICAN EDWARDS LABORATORIES	PAPER CHART RECORDER	1981-07-10
PMN K811253 AMERICAN EDWARDS LABORATORIES	CASSETTE READER	1981-07-10
PMN K811411 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ HEPARIN COATED, ETC. CATHETER	1981-06-12
PMN K811399 AMERICAN EDWARDS LABORATORIES	EDSLAB CLOSED INJECTATE DELIVERY SYSTEM	1981-06-09
PMN K810894 AMERICAN EDWARDS LABORATORIES	FOGARTY FLEXIBLE CALIBRATOR	1981-05-15
PMN K810352 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ FLOW-DIRECTED THERMODILUTION	1981-03-27
PMN K803270 AMERICAN EDWARDS LABORATORIES	GANZ CORONARY REPERFUSION CATHETER	1981-03-27
PMN K810162 AMERICAN EDWARDS LABORATORIES	FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06	1981-02-04
PMN K810124 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ VIP THERMODILUTION CATHETER	1981-02-04
PMN K803058 AMERICAN EDWARDS LABORATORIES	SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.	1981-01-16
PMN K803225 AMERICAN EDWARDS LABORATORIES	ADVANCEMED EXAMINER	1981-01-13
PMN K803224 AMERICAN EDWARDS LABORATORIES	ADVANCEMED HOLTER RECORDERS	1981-01-13
PMN K803223 AMERICAN EDWARDS LABORATORIES	ADVANCMED ELIMINATOR	1981-01-13
PMN K803222 AMERICAN EDWARDS LABORATORIES	ADVANCEMED CCU DOCUMENTOR	1981-01-13
PMN K803057 AMERICAN EDWARDS LABORATORIES	FOGARTY BALLON ANGIOPLASTY CATHETERS	1981-01-13
PMN K802670 AMERICAN EDWARDS LABORATORIES	CONTIUOUS WAVE DOPPLER ULTRASOUND	1980-11-26