American Edwards Laboratories

89 FDA 510(k) medical device clearances.

Top product codes for American Edwards Laboratories

HRX — Orthopedic 7 devices
DQO — Cardiovascular 6 devices
DYG — Cardiovascular 6 devices
FRN — General Hospital 6 devices
LIT — Cardiovascular 6 devices
EZN — Gastroenterology, Urology 5 devices
DXG — Cardiovascular 4 devices
DQY — Cardiovascular 3 devices
DSH — Cardiovascular 3 devices
DWP — Cardiovascular 3 devices

Recent clearances by American Edwards Laboratories

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.