FDA.reportPublic FDA data

ANDERSEN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10648583008397795ANDERSEN SCIENTIFIC, INC.1N2026-01-011001 Aviation Parkway Suite 600 Morrisville NC US 27560
30045301843004530184ANDERSEN CALEDONIA LTD1N2026-01-01Caledonian House, Phoenix Crescent Strathclyde Business Park Bellshill Scotland GB ML4 3NJ
30046347103004634710Andersen Sterilizers, Inc.1N2026-01-013154 Caroline Dr Haw River NC US 27258
30159606763015960676ANDERSEN INDUSTRIES CO., LTD.1N2026-01-01National Road.4 Srah Sangkom (Srassangkom) Village, Peuk, Commun Angsnoul District Kandal KH 08315
10538251000112091ANDERSEN PRODUCTS, INC.1N2020-04-253202 CAROLINE DR., HEALTH SCIENCE PARK HAW RIVER NC US 27258

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060485030263AN85 EO Indicator, Type 1 Process Indicator - AN85.00 EO Indicator, Type 1 Process Indicator, 200 units800-523-1276customerservice@anpro.com
05060485030270AN86 EO Indicator, Type 1 Process Indicator - AN86.00 EO Indicator, Type 1 Process Indicator, 200 units800-523-1276customerservice@anpro.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1528811045939118K990910MTP HAMOU ENDOMAT DISPOSABLE TUBING SETSHIH1999-06-03
1528811021340258K990909MTP UROPUMP DISPOSABLE TUBING SETLJH1999-06-09
1528811061501127K972267HELICA TCGEI1999-09-14
68871297263647K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
68871849931435K935688AN-10S ANDERSEN TUBE WITH STYLETBSS1994-12-30
1930241439595263K213296Anprolene SteriTest RRBIFRC2022-04-12
1930241516437180K202879EOGas 4 Endo-SteriTest RRBIFRC2021-03-03
1930241245147143K200336Tyvek Sterilization Pouches with Chevron SealFRG2020-11-12
1930241668824846K200335Sterisheet Sterilization WrapFRG2020-11-12
1930241608618442K200334AN1036 DosimeterJOJ2020-11-12
1930241832005811K192980EOGas 4 Endo-SteriTestFRC2020-11-12
1930241525048982K192978EOGas 4 Ethylene Oxide Gas SterilizerFLF2020-11-12
1930242024658888K170439AN87 DosimeterJOJ2017-11-01
1930241782304850K170437Sterisheet Sterilization WrapFRG2017-11-01
1930241550233228K170432Anprolene AN75 Ethylene Oxide Gas SterilizerFLF2017-10-31
1930241925484050K170429Tyvek Sterilization Pouches with Chevron SealFRG2017-10-27
1930241535469380K170427Anprolene SteriTestFRC2017-10-31
1930241364931061K170426AN85/AN86 EO IndicatorsJOJ2017-10-30
1930241239963268K152291Sterisheet Sterilization WrapFRG2015-12-17
1930241883709394K152058Tyvek Sterilization Pouches with Chevron SealFRG2015-11-18
1930241100373118K151585Andersen EOGas 4 SteriTestFRC2015-11-18
1930241307639054K150646EOGas 4 Ethylene Oxide Gas SterilizerFLF2015-11-18
1930241363724715K150645AN1087 DosimeterJOJ2015-11-19
1930241832070055K150644AN85/AN86 EO IndicatorsJOJ2015-11-18
1528811524728191K112322RESTORELLE POLYPROPYLENE Y MESHOTO2012-05-17
1528811169789726K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXHPZ2011-11-02
1528811484412977K103820REPROBONE DENTAL GRAFTING MATERIALLYC2011-11-03
1528811406569127K103568RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESHFTL2010-12-22
1528811438013186K102076LIQUIBAND DUAL, MODEL LBD 001MPN2011-02-18
1528811583931046K092207RESTORELLE POLYPROPYLENE MESHOTP2009-08-04
1528811101256663K092203OMNISURE URETHRAL SLING, MODEL OTK52OTN2009-08-12
1528811627145348K091180MINITAPE URETHRAL SLINGPAH2009-07-14
1528811742971095K090598CARIESCAN PRONBL2009-12-15
1528811846253403K083292HABIB ENDOHPBKNS2009-06-10
1528811630118080K073687HABIB LAPAROSCOPIC HEXABLATEGEI2008-01-09
1528811092425894K073647MINITAPE EXTRA URETHRAL SLINGOTN2008-03-03
1528811409232443K073646MINITAPE URETHRAL SLINGPAH2008-02-25
1528812011596001K072383HABIB ENDOBLATEKNS2007-11-29
1528811578207527K072126HABIB VESEALGEI2007-10-02
1528811277133244K071103HABIB HEXABLATEGEI2007-06-27
1528811301286211K053361MODIFICATION TO: MINIMESH POLYPROPYLENE MESHOTO2006-02-06
1528811024684012K051712MODEL 2800 PFT FILTERBZG2005-09-01
1528812010413080K051420HABIB 4XGEI2005-08-15
1528811583218450K050953AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLECAH2005-06-29
1528811131533587K041632MINIMESH POLYPROPYLENE MESHOTO2004-11-17
1528811981832341K040712AIR SAFETY HEPA, MODEL 3500MOD2004-06-03
1528811119230941K033008AIR SAFETY HEPA AND NON-HEPA FILTERSCAH2004-05-13
1528811804374778K032969HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBEGEI2004-02-04
68871299972548K021493ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18SKNT2002-08-30
1528811812270087K011360MTP LAPAROMAT DISPOSABLE TUBING SETGCJ2001-07-19
68871180758338K011077ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)KNT2001-05-09
2334001829938583
68871947357403
68872003809748
1528811007585500
551641008782814
1528811022938392
1528811024581833
1528811026472276
2334001028297135
551641028762435
1528811032672162
2334001033418415
1528811038113724
1528811040166361
2334001047736562
2334001053282794
2334001055534227
551641057533134
1528811062543486
1528811072226132
1528811074396479
1528811081855787
2334001097184562
551641099307792
1528811102651967
551641104008879
1528811108775840
1528811114904999
1528811119108741
1528811141066419
1528811151079010
1528811156360281
1528811159565130
2334001162178679
551641167539299
1528811175439150
551641177967344
551641183129231
1528811195922347
551641198528701
551641201840189
1528811202465518
1528811234066527
551641246110269
551641246252946
2334001249122832
551641249606481
1528811260732618
2334001275675327
551641285316728
551641298494278
551641312399285
1528811313805068
1528811326589434
1528811330444735
551641330700198
551641341618660
551641342190619
551641342726443
2334001343277026
551641345563578
1528811351192410
551641353009396
1528811353199605
1528811354989396
2334001367883739
551641368595115
2334001371949687
551641372704021

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI72008-01-09
FRG62020-11-12
FRC52022-04-12
JOJ52020-11-12
FLF32020-11-12
OTO32012-05-17
OTN22009-08-12
PAH22009-07-14
KNS22009-06-10
CAH22005-06-29
KNT22002-08-30
LYC12011-11-03
HPZ12011-11-02
MPN12011-02-18
FTL12010-12-22
NBL12009-12-15
OTP12009-08-04
BZG12005-09-01
MOD12004-06-03
GCJ12001-07-19
LJH11999-06-09
HIH11999-06-03
BSS11994-12-30

PMN#

Applications#

GUDID#

65 records. Showing 1-40. Next