FDA.reportPublic FDA data

STRADIS HEALTHCARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10557541000111025STRADIS HEALTHCARE1N2020-04-253025 Northwoods Pkwy Peachtree Corners GA US 30071
14509431450943STRADIS HEALTHCARE1N2020-04-253600 Bur Wood Dr WAUKEGAN IL US 60085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
457331251540249K993463INTRAVASCULAR ADMINISTRATION SETFPA2000-01-04
457332070792188K990519PHOENIX EPIDURAL & SPINAL NEEDLESBSP2000-06-02
457331397443862K971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBINGMIB1997-05-22
457331029260384K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAFTL1997-07-01
457331335584552K970814NON-STERILE ISOLATION GOWNFYC1997-05-27
457331489855288K961222EVRON GELKMJ1996-06-26
1878781892222979K953474IV START KITFPA1995-10-02
1878781503287776K943829PRE-FILLED SYSRINGE W/STERILE WATERJOL1994-11-21
457331746870209K943424CUSH ISLAND DRESSINGMGP1994-10-03
457331236581863K941645BIOPSY TRAYFRG1994-07-14
1878781211607787K941542ORION CENTRAL LINE DRESSING CHANGE TRAYFRG1994-05-23
457331261607258K941349DENTAL TRAYEIA1994-07-26
457331462518077K940646ORTHOPEDIC TRAY PRODUCT LINELRP1994-03-11
457331147751551K940444GENERAL SURGERY TRAYLRP1994-03-07
457331937892154K940239EYE TRAYLRP1994-06-28
457331985416965K935743INSTRUMENT TRAYLRO1994-03-03
457331703464197K935697CIRCUMCISION TRAYHFX1994-05-02
457331935346990K935682LACERATION TRAYFRG1994-02-10
1878781578794048K923960UPPER EXTERMITY DRAPE KITKKX1994-10-07
1878781895609119K921733TRACHEOSTOMY CARE TRAYJOH1994-06-15
1878781642381909K920341LACERATION TRAYSKKX1992-04-23
1878781800256826K920340SUTURE REMOVAL KITKKX1992-04-23
1878781693699284K920339DRESSING CHANGE TRAYFRG1992-04-23
457331336266686K911732ADVANCE DISPOSABLE CONTROL SYRINGEIZI1991-09-16
1878781925124236K902828SUTURE REMOVAL TRAYLRW1990-08-08
1878781009071444K901185FOLEY CATHETER INSERTION TRAY (10CC)FCM1990-07-20
1878781223646225K901181CATHETER CARE TRAYFCM1990-07-20
1878781778402682K901109WOUND TREATMENT KITFRO1990-06-06
457331331458503K872612SOLOS EYESITE SPONGESHOZ1987-07-31
457331127594595K780673CENTRAL CATHETER KITFPK1978-05-16
457331209860329K130798PRE-FORMED GUIDEWIRESDQX2013-08-23
457331917192222K130404TIBURON SURGICAL DRAPEKKX2013-07-05
457331198156023K102969IMC PISTON SYRINGESFMF2010-12-20
457331852153748K101979EXPLORER LIVER (PASSIVE TRACKING)OEW2011-02-09
457331944031408K101399COAXIAL INTRODUCER SETDYB2010-06-17
457331858644688K073182GYN DISPOSABLES TENACULUM 356THDC2007-11-28
457331044533363K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERFTA2006-01-19
457331587514048K052550IMC SURGICAL GOWNSFYA2005-11-17
457331512693004K043525CATHETER INTRODUCERDYB2005-02-09
457331982530692K041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSMMP2004-11-30
457331346679648K032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMMP2003-09-22
457332040799395K014239MEDSURG EQUIPMENT COVERSMMP2002-02-19
457331289602934K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITEKKX2000-08-17
457331006320500
1878781042699317
457331045376137
457331073141915
457331097859017
457331099117245
457331100959802
457331125515610
457331140342273
1878781140342273
457331149412302
457331155424588
1878781159530607
1878781178956172
457331189450624
457331194776470
457331203782076
457331230315170
457331260028675
457331315266319
457331361184007
457331386559075
1878781386559075
457331391117263
457331416445855
457331451377843
457331457109502
457331461217899
457331474827762
1878781498706895
457331510937281
457331541061759
457331546063416
457331561870891
1878781563523447
1878781570189363
1878781579565403
457331601377252
457331601770059
457331637142421
1878781638406701
1878781639452579
1878781639950078
1878781656950406
457331757223188
457331757711330
457331763828000
457331781853865
457331785825698
457331790746719
457331800058673
457331829055781
457331853787125
1878781853787125
1878781864924637
457331910448110
457331936038344
457331947015864
1878781947015864
1878781976351707
457331985893853
457331992914134
1878781995796102
457332019660506
457332026753624
457332051049036

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX52013-07-05
FRG41994-07-14
MMP32004-11-30
LRP31994-06-28
DYB22010-06-17
FPA22000-01-04
FCM21990-07-20
DQX12013-08-23
OEW12011-02-09
FMF12010-12-20
HDC12007-11-28
FTA12006-01-19
FYA12005-11-17
BSP12000-06-02
FTL11997-07-01
FYC11997-05-27
MIB11997-05-22
KMJ11996-06-26
JOL11994-11-21
MGP11994-10-03
EIA11994-07-26
JOH11994-06-15
HFX11994-05-02
LRO11994-03-03
IZI11991-09-16
LRW11990-08-08
FRO11990-06-06
HOZ11987-07-31
FPK11978-05-16

PMN#