Company ยท US
American Edwards Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1987. Name variants (Inc, Corp, punctuation) are merged.
89510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| DYG | Catheter, Flow Directed | 6 |
| FRN | Pump, Infusion | 6 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 6 |
| EZN | Dilator, Catheter, Ureteral | 5 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 |
| DQY | Catheter, Percutaneous | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 3 |
| DWP | Dilator, Vessel, Surgical | 3 |
| KOD | Catheter, Urological | 3 |
| LJE | Catheter, Nephrostomy | 3 |
| LYK | Angioscope | 3 |
| DSF | Recorder, Paper Chart | 2 |
| DXC | Clamp, Vascular | 2 |
| DXT | Injector And Syringe, Angiographic | 2 |
| KRB | Probe, Thermodilution | 2 |
| LDF | Electrode, Pacemaker, Temporary | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 1987 | K873485 | EDSLAB (R) OCCLUSION BALLOON CATHETER American Edwards Laboratories | DQY |
| Sep 30, 1987 | K872596 | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 American Edwards Laboratories | DRS |
| Sep 15, 1987 | K872529 | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 American Edwards Laboratories | DXG |
| Apr 17, 1987 | K870444 | HOMEPRO II VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Feb 27, 1987 | K864997 | MEDTRAC VP VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Jan 6, 1987 | K864330 | SHEAR FORCE GAUGE American Edwards Laboratories | DXE |
| Jan 2, 1987 | K862724 | VEIN VALVE CUTTER American Edwards Laboratories | DQY |
| Nov 20, 1986 | K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS American Edwards Laboratories | DTJ |
| Nov 20, 1986 | K863596 | CHIN-FOGARTY INFLATION DEVICE American Edwards Laboratories | DXT |
| Oct 31, 1986 | K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES American Edwards Laboratories | HRX |
| Oct 24, 1986 | K862872 | FLEXIBLE VISUALIZATION CATHETER American Edwards Laboratories | FEI |
| Oct 3, 1986 | K863605 | ARTHROSCOPIC IRRIGATION PUMP American Edwards Laboratories | HRX |
| Oct 3, 1986 | K863604 | DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE American Edwards Laboratories | |
| Oct 2, 1986 | K863598 | VIDEO CAMERA SYSTEM American Edwards Laboratories | FWF |
| Sep 29, 1986 | K863696 | ARTHROSCOPIC SURGICAL POWER DEVICE American Edwards Laboratories | KIT |
| Sep 25, 1986 | K863597 | AMERICAN EDWARDS 4.0 MM ARTHROSCOPE American Edwards Laboratories | HRX |
| Sep 3, 1986 | K862547 | MECHANICAL INFLATION DEVICE American Edwards Laboratories | DXT |
| Feb 12, 1986 | K855000 | RATEMINDER III INFUSION DEVICE American Edwards Laboratories | LDR |
| Oct 4, 1985 | K853514 | RIGID ENDOSCOPE American Edwards Laboratories | GCM |
| Aug 23, 1985 | K853337 | TROCAR/CANNULA/SHEATH SET American Edwards Laboratories | KOD |
| Aug 22, 1985 | K852759 | AMERICAN EDWARDS LABORATORIES FLEXISCOPE American Edwards Laboratories | HRX |
| Aug 21, 1985 | K852324 | URETERAL DILATOR American Edwards Laboratories | EZN |
| Aug 9, 1985 | K852793 | URETERAL DILATOR/SHEATH SET American Edwards Laboratories | EZN |
| Jun 28, 1985 | K851374 | AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE American Edwards Laboratories | HRX |
| Apr 3, 1985 | K850954 | URETERAL DILATOR & URETERAL STONE DISLODGER American Edwards Laboratories | FFL |
| Mar 25, 1985 | K850790 | DIAFLEX OCCLUSION BALLOON CATHETER American Edwards Laboratories | KOD |
| Feb 15, 1985 | K841374 | HOME PRO VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Jan 15, 1985 | K845048 | NEPHROSTOMY DRAINAGE CATHETER & STIFFENER American Edwards Laboratories | LJE |
| Jan 15, 1985 | K845047 | NEPHROSTOMY GUIDEWIRE SHEATH American Edwards Laboratories | LJE |
| Jan 15, 1985 | K842105 | RIGHT VENTRICULAR EJECTION FRACTION- American Edwards Laboratories | DXG |
| Jan 14, 1985 | K841401 | SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER American Edwards Laboratories | DXG |
| Dec 5, 1984 | K844090 | PERCUTANEOUS NEPHROSTOMY TROCAR SYS American Edwards Laboratories | LJE |
| Nov 5, 1984 | K842410 | AMER. EDWARDS LAB FLEXISCOPE American Edwards Laboratories | HRK |
| Nov 1, 1984 | K833763 | PERICARDIAL PATCH American Edwards Laboratories | DXZ |
| Oct 19, 1984 | K843274 | MODULAR VOLUMETRIC INFUSION PUMP SYS American Edwards Laboratories | FRN |
| Oct 18, 1984 | K842481 | AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE American Edwards Laboratories | LYK |
| Oct 2, 1984 | K842639 | AMER. EDWARDS LAB DIAFLEX URETERAL DILA American Edwards Laboratories | EZN |
| Oct 2, 1984 | K842632 | DILATOR/SHEATH SET American Edwards Laboratories | EZN |
| Oct 2, 1984 | K842206 | DIAFLEX NEPHROSTOMY BALLOON DILATOR American Edwards Laboratories | EZN |
| Aug 18, 1984 | K841607 | AMERICAN EDWARDS LABS FLEXISCOPE American Edwards Laboratories | HRX |
| Aug 17, 1984 | K842323 | AMER. EDWARDS LAB FLEXISCOPE OBTURATOR American Edwards Laboratories | HRX |
| Aug 10, 1984 | K842799 | PERCUTANEOUS ANGIOSCOPE DELIVERY CATH American Edwards Laboratories | DQO |
| Aug 10, 1984 | K842798 | INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH American Edwards Laboratories | DQO |
| Aug 10, 1984 | K834429 | PERIPHERAL DILATATION ANGIOPLASTY-CATH American Edwards Laboratories | LIT |
| Jul 13, 1984 | K841922 | ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 American Edwards Laboratories | FRN |
| Jun 11, 1984 | K834547 | ANGIOSCOPY CATHETER American Edwards Laboratories | LYK |
| Apr 17, 1984 | K833997 | CO-SET American Edwards Laboratories | |
| Apr 13, 1984 | K840746 | URETERAL DILATOR American Edwards Laboratories | KOE |
| Feb 4, 1984 | K834459 | DIAGNOSTIC RADIOLOGY CATHETERS American Edwards Laboratories | DQO |
| Jan 27, 1984 | K834220 | HYBRID PERIPHERAL DILATION CATHETER American Edwards Laboratories | LIT |
Newest 50 of 89.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||