510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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American Edwards Laboratories

Walker, MI, US

American Edwards Laboratories appears in FDA device records in Walker, MI. FDA records list 89 510(k) clearances between and , 8 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
89
PMA records
8
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 89

FDA records hold 89 510(k) clearances for American Edwards Laboratories between 1980 and 1987. The busiest year on record is 1981, with 21. The most recent is 1987, with 7.

Clearances by year, as a table
510(k) clearance decisions for American Edwards Laboratories, by decision year
YearClearances
19801
198121
19825
198312
198419
198513
198611
19877
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K873485EDSLAB (R) OCCLUSION BALLOON CATHETERDQYSubstantially Equivalent
K872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30DRSSubstantially Equivalent
K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2DXGSubstantially Equivalent
K870444HOMEPRO II VOLUMETRIC INFUSION PUMPFRNSubstantially Equivalent
K864997MEDTRAC VP VOLUMETRIC INFUSION PUMPFRNSubstantially Equivalent
K864330SHEAR FORCE GAUGEDXESubstantially Equivalent
K862724VEIN VALVE CUTTERDQYSubstantially Equivalent
K864155MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESISDTJSubstantially Equivalent
K863596CHIN-FOGARTY INFLATION DEVICEDXTSubstantially Equivalent
K863986XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURESHRXSubstantially Equivalent
K862872FLEXIBLE VISUALIZATION CATHETERFEISubstantially Equivalent
K863605ARTHROSCOPIC IRRIGATION PUMPHRXSubstantially Equivalent
K863604DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICESubstantially Equivalent
K863598VIDEO CAMERA SYSTEMFWFSubstantially Equivalent
K863696ARTHROSCOPIC SURGICAL POWER DEVICEKITSubstantially Equivalent
K863597AMERICAN EDWARDS 4.0 MM ARTHROSCOPEHRXSubstantially Equivalent
K862547MECHANICAL INFLATION DEVICEDXTSubstantially Equivalent
K855000RATEMINDER III INFUSION DEVICELDRSubstantially Equivalent
K853514RIGID ENDOSCOPEGCMSubstantially Equivalent
K853337TROCAR/CANNULA/SHEATH SETKODSubstantially Equivalent
K852759AMERICAN EDWARDS LABORATORIES FLEXISCOPEHRXSubstantially Equivalent
K852324URETERAL DILATOREZNSubstantially Equivalent
K852793URETERAL DILATOR/SHEATH SETEZNSubstantially Equivalent
K851374AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPEHRXSubstantially Equivalent
K850954URETERAL DILATOR & URETERAL STONE DISLODGERFFLSubstantially Equivalent
K850790DIAFLEX OCCLUSION BALLOON CATHETERKODSubstantially Equivalent
K841374HOME PRO VOLUMETRIC INFUSION PUMPFRNSubstantially Equivalent
K845048NEPHROSTOMY DRAINAGE CATHETER & STIFFENERLJESubstantially Equivalent
K845047NEPHROSTOMY GUIDEWIRE SHEATHLJESubstantially Equivalent
K842105RIGHT VENTRICULAR EJECTION FRACTION-DXGSubstantially Equivalent
K841401SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTERDXGSubstantially Equivalent
K844090PERCUTANEOUS NEPHROSTOMY TROCAR SYSLJESubstantially Equivalent
K842410AMER. EDWARDS LAB FLEXISCOPEHRKSubstantially Equivalent
K833763PERICARDIAL PATCHDXZSubstantially Equivalent
K843274MODULAR VOLUMETRIC INFUSION PUMP SYSFRNSubstantially Equivalent
K842481AMERICAN EDWARDS MINI-FLEX ANGIOSCOPELYKSubstantially Equivalent
K842639AMER. EDWARDS LAB DIAFLEX URETERAL DILAEZNSubstantially Equivalent
K842632DILATOR/SHEATH SETEZNSubstantially Equivalent
K842206DIAFLEX NEPHROSTOMY BALLOON DILATOREZNSubstantially Equivalent
K841607AMERICAN EDWARDS LABS FLEXISCOPEHRXSubstantially Equivalent
K842323AMER. EDWARDS LAB FLEXISCOPE OBTURATORHRXSubstantially Equivalent
K842799PERCUTANEOUS ANGIOSCOPE DELIVERY CATHDQOSubstantially Equivalent
K842798INTRAOPERATIVE ANGIOSCOPE DELIVERY CATHDQOSubstantially Equivalent
K834429PERIPHERAL DILATATION ANGIOPLASTY-CATHLITSubstantially Equivalent
K841922ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232FRNSubstantially Equivalent
K834547ANGIOSCOPY CATHETERLYKSubstantially Equivalent
K833997CO-SETSubstantially Equivalent
K840746URETERAL DILATORKOESubstantially Equivalent
K834459DIAGNOSTIC RADIOLOGY CATHETERSDQOSubstantially Equivalent
K834220HYBRID PERIPHERAL DILATION CATHETERLITSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain