FDA.reportPublic FDA data

Winco

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
WINNER MEDICAL (HUNAN) CO., LTD.5N2026-01-01No. 8 Industry AVE, Economic Development Zone Changde Hunan CN 415500
14245243003036307WINCHESTER LABORATORIES, LLLP1N2026-01-01301 W. Atlantic Avenue SUITE 01 Delray Beach FL US 33444
16290571629057WINFIELD LABORATORIES, INC.1N2026-01-011221 W Campbell Rd Ste 201 Richardson TX US 75080
22267022226702WINDSOR EYES1Y2026-01-017100 Airport Highway Pennsauken NJ US 08109
30251681000125955WINDSTONE MEDICAL PACKAGING, INC.1N2026-01-011602 4th Ave N BILLINGS MT US 59101
96125013003495548Wing Ng1N2026-01-0115 Hampshire Street Mansfield MA US 02048
96146043003191236WING KEUNG OPTICAL MANUFACTURING LTD1N2026-01-01Zi Cheng Industrial Area Xi Feng Province Shaoguan Guangdong CN 511000
30019492703001949270WINNING APPLIANCE MANUFACTORY LIMITED1N2026-01-013A 29-31 LEE CHUNG ST. CHAI WAN HONG KONG Xinjiang CN --
30027325853002732585WINSTON OPTICAL D/B/A WINSTON TECHNOLOGY SYSTEMS, CORP.1Y2026-01-01378 N. WOODLAND ST. Englewood NJ US 07631
30044938763004493876WINDSOR BEACH TECHNOLOGIES, INC.1N2026-01-017321 KLIER DR. EAST FAIRVIEW PA US 16415
30055487403005548740WINFAME USA INC.1Y2026-01-01710 S. Myrtle Ave STE 189 Monrovia CA US 91016
30085729463008572946WINBEST BIOTECH (THAILAND) CO. LTD.1N2026-01-013/6 Moo 3, Sanamchan Subdistrict Ban Pho Chachoengsao TH 24140
30106109503010610950Winner Medical (Chongyang) Co., Ltd.1N2026-01-01No. 9A, Jincheng Avenue, Zhongjin Village, Tiancheng Town Chongyang Hubei CN 437500
30131827653013182765WINNIE Zhu1N2026-01-011840 Pickwick Ave Glenview, lL Us Glenview IL US 60026
30137344323013734432WINNIE Zhu1N2026-01-011840 Pickwick Ave Glenview, lL Us Glenview IL US 60026
30143107793014310779WINGDERM ELECTRO-OPTICS LTD.1N2026-01-01Building 6, No.97 Changping Road, Changping District Beijing CN 102206
30157291423015729142Winx Health Inc1N2026-01-01184 Tuckerton Rd Unit 2 Reading PA US 19605
30165123433016512343WINBACK GO EAST Co Ltd1N2026-01-01161, Usangongdan-Gil Wonju-si Gangwon KR 26335
30172688323017268832WINNIE Zhu1N2026-01-011840 Pickwick Ave Glenview, lL Us Glenview IL US 60026
30211908023021190802Winter Innovations, Inc.1N2026-01-017625 Golden Triangle Drive Suite G Eden Prairie MN US 55344
30233209493023320949WIN-WIN OPTICS CO., LIMITED1N2026-01-01ROOM 803B, 8/F., WEST COAST INTERNATIONAL BUILDING, 290-296 UN C HONG KONG HK 999077
30256864273025686427Windstone Medical Packaging, Inc.1N2026-01-011400 Montana Ave. Billings MT US 59101
30369786023036978602Winner Medical (Jiayu) Co., Ltd.1N2026-01-01No.199, Jiayu Avenue Jiayu Hubei CN 437200
00WINWIN PRODUCTS, INC.1Y2020-04-254720 Simonton Rd Farmers Branch TX US 75244
00WINTRAD BIOTECH CO., LTD5Y2020-04-253907 Prince St Ste 6C Flushing NY US 11354

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
00070552250000Winco Foods Early Result Pregnancy Test - Winco Foods DPS Early Result800-824-1706xx@xx.xx
00070552250000Winco Foods Early Result Pregnancy Test - Winco Foods DPS Early Result800-899-7353xx@xx.xx
00070552250017Winco Foods One Step Pregnancy Test - FPPL Winco Foods SPS +/-800-899-7353xx@xx.xx
00070552250017Winco Foods One Step Pregnancy Test - FPPL Winco Foods SPS +/-800-824-1706xx@xx.xx
00070552250963Winco Foods - Winco SPS +/- Blue Cap800-824-1706xx@xx.xx
00070552250963Winco Foods - Winco SPS +/- Blue Cap1-800-899-7353xx@xx.xx
00855630004498TMM - S400 Manual Patient Transfer Stretcher Chair800-237-3377customer.service@wincomfg.com
10070552251042WinCo - Compact First Aid Kit208-672-2471Susan.Barry@wincofoods.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2323371950166669K994312MALE LATEX CONDOM 56MMHIS2000-03-21
191041083109070K993969SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTIONFRO1999-12-30
17961853464007K993672REBAR MICRO CATHETER, MODELS 105-5080, 105-5086KRA2000-01-04
17961056360292K992288AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVEGCJ1999-07-30
17961066233541K990952NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURESGAT1999-04-01
17961960998758K990951MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTUREGAM1999-04-01
17961414967044K981941MULTAPORT CANNULA REDUCER AND ACCESSORIESGCJ1998-07-29
17961880788543K981935POLYSORB SUTUREGAM1998-06-25
17961227977221K981582SURGILON, DERMALON, & OPHTHALONGAR1998-07-13
17961876689986K981128SOFSILK SUTUREGAP1998-05-11
17961414603158K974187STEALTHSTATION SYSTEMHAW1998-01-21
17961198844483K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKGCJ1998-01-16
17961051650559K963253SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1996-10-08
17961152094511K963115TROCAR CANNULAGCJ1997-02-12
17961007435365K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEPGCJ1996-07-10
17961932072450K961430INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEPGCJ1996-05-28
17961270344865K955747USSC NONABSORBABLE SUTURESGAT1996-02-27
17961846062299K955723STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)GAQ1996-02-27
17961691667078K955722FLEXON TEMPORARY CARDIAC PACER LEADLDF1996-03-15
17961221147782K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
17961101490535K954808USSC POLYPROPLENE SUTUREGAW1996-02-27
17961681315313K954435WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINESFZP1995-10-23
17961047213256K954108MODIFIED VERSAPORTGCJ1995-10-17
17961901519758K953289TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGETDXZ1995-08-21
17961618763175K952977SABRE MULTI-USE TROCAR SYSTEMGCJ1995-07-17
17961830913940K950632INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPGCJ1995-05-12
17961491353061K945701SURGILENE(R) SUTURESGAW1995-01-24
17962014904619K943976SABRE ULTIMATE SHIELDED TROCARGCJ1994-09-07
17961889608127K943676DANEKSCOPE OPTI-PROBEHRX1994-11-21
17961242169578K935426PREPERITONEAL DISTENTION BALLOON SYSTEMGCJ1994-01-26
17961210190184K935086AUTO SUTURE DISPOSABLE OPTICAL TROCARGCJ1994-02-17
17961648471370K934738AUTOSUTURE ENDOSCOPIC SUTURING DEVICEOCW1994-03-16
17961069397719K930591TI-CRON AND DACRON SUTURESGAT1993-12-17
17961848755825K930589PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTURGAL1993-12-17
17962016570922K925149AUTO SUTURE ENDOSCOPIC KNOT PUSHERGCJ1993-01-26
17961796707763K924011ORIGIN BLUNT TIP SURGICAL TROCARGCJ1993-07-09
17961665142872K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHGCI1993-02-01
17961038191736K920068AUTO SUTURE ENDOSCOPIC MINI-RETRACTORGCJ1992-09-17
17961045949544K912973ENDOSCOPE SUTURE & CARRIERGCJ1991-09-27
17961811450578K905035AXOSTIM NERVE STIMULATOR, MODIFICATIONETN1991-04-19
17961693532708K904588AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOPGAL1990-12-24
17961282093830K903419MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVEGDH1990-08-09
121151950398084K902475CARDIO-PAK ANGIOGRAPHY CUSTOM PACKSDXT1990-12-03
17961920580602K900531NONABSORBABLE NYLON SURGICAL SUTURE*GAR1990-07-05
17961177128142K900123AUTO SUTURE SURGIPORT SPIRAL SLEEVEFBQ1990-04-04
17961594202374K885018ABSORBABLE SURGICAL GUT SUTURE*GAL1989-08-22
17961336733914K834094AUSTIN ENDOLYMPH DISPERSMENT SHUNTESZ1984-09-20
17961638340932K790915JUHN TYM-TAPFMH1979-06-27
17961350767157K781529SEPTAL BUTTONLFB1978-10-17
17961493737500K780695AUTO SUTURE DISPOSABLE STAPLING INSTRU.GDW1978-06-22
2988781132134010K261021EasyWhip FamilyGAT2026-07-01
2340731226278833K252599Diode Laser Therapy Systems (WLA-02)GEX2026-02-24
17961220530191K250725Hugo™ RAS SystemSCV2025-12-03
17961785838863K241486Sofsilk™ Coated Braided Silk SutureGAP2024-12-03
3266341301023582K231845Dental unit Model: MareEIA2024-02-28
2394811315029032K230167BACK 4IPF2023-09-14
2394811757612160K230037BACK 3PBX2023-07-19
2394811303150719K220014RSHOCKPBX2023-03-01
2394811400679986K214090Back 3 COLORPBX2022-11-01
17961018879281K213818VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon CannulaGCJ2022-06-27
2988781982673784K210675EasyWhipGAT2021-05-03
2340731709844064K192350Medical Non-Ablative Fractional Laser SystemsONG2020-04-30
2340731114493187K191611Diode Laser Therapy SystemsGEX2019-07-31
597411885047914K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL2018-11-30
17961411036291K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocarGCJ2017-03-08
2394811197413447K162828Winback Back 3SEPBX2017-09-18
17961478474998K162584VersaOne Bladeless TrocarGCJ2016-10-18
17961920031397K160230VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mmGCJ2016-03-01
17961185009394K152149VersaOne Bladed Trocar 5mmGCJ2016-01-22
17961870204026K151758ALAR Nasal Valve StentGAT2015-10-29
17961899208812K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarGCJ2015-07-02
2323371313408675K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test MidstreamLCX2015-08-07
17961499309727K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿FZP2015-09-14
17961667801222K142656Surgical Gut SutureGAL2015-01-29
17961201188172K142547Bluntport Blunt Trocar with Threaded Anchor 5mm-12mmGCJ2014-12-09
597411823552323K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,LPL2013-09-11
17961460606569K130608QUADCUTHAW2013-08-07
17961244387894K130435VERSAPORT V2 BLADELESS OPTICAL TROCARGCJ2013-03-14
17961735275182K121194ENDO CLIP III 5MM CLIP APPLIERFZP2012-05-03
17961092784775K112349VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCARGCJ2011-09-01
17961649670943K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSGDW2011-10-25
592201441301839K102080DEPUY RECLAIM REVISION HIP SYSTEMLZO2010-11-23
17961199531496K100548VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLPGCJ2010-04-26
17961349651191K100242AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTERFZP2010-02-17
17961362328674K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAKRA2009-12-09
17961864327099K081169AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCARGCJ2008-05-23
17961661980891K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERFZP2007-11-21
2323371097955643K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSLJX2007-10-12
17961493961552K062779DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)GCJ2006-10-05
17961257461797K062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEGCJ2006-09-01
17961479556929K051990ECHELON MICRO CATHETERKRA2006-01-04
17961031538577K050947MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTUREGAW2005-06-01
17961620372456K042187ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90KRA2004-09-02
2323371083685700K041273ONE-STEP PREGNANCY TESTLCX2004-05-20
17961443217136K032586CAPROSYN ABSORBABLE SUTUREGAM2003-11-17
17961657470772K031992ECHELON MICRO CATHETER, MODEL 105-5091KRA2003-08-07
17961503493574K030688ECHELON MICRO CATHETER, MODEL 105-5092-150KRA2003-03-28
17961979238229K012543VISION SCIENCES ENDOSHEATH SYSTEMEOB2002-07-15
17962059396502K012539VERASTEPGCJ2001-09-06
17961862145773K010909NONABSORBABLE POLYPROPYLENE SURGICAL SUTUREGAW2001-04-09
17961136351015K002723REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MAKRA2000-09-28
17961773072441K001966REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BANDKRA2000-07-20
17961245518968K000037MONOFILAMENT BIOSYN SUTUREGAM2000-03-30
1652201183942208
1652201207919558
105111290781303
1652201302184354
1652201456990892
1652201568444268
1652201594598365
17961612314232
1652201665317561
1652201742731147
1652201794723091
17961806750204
1652201932850773
17961005085627
247721009282974
17961013393399

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ312022-06-27
KRA82009-12-09
GAT62026-07-01
FZP52015-09-14
GAM52003-11-17
PBX42023-07-19
GAL42015-01-29
GAW42005-06-01
GEX22026-02-24
GAP22024-12-03
LPL22018-11-30
LCX22015-08-07
HAW22013-08-07
GDW22011-10-25
GAR21998-07-13
DXZ21995-08-21
SCV12025-12-03
EIA12024-02-28
IPF12023-09-14
ONG12020-04-30
LZO12010-11-23
LJX12007-10-12
EOB12002-07-15
HIS12000-03-21
FRO11999-12-30
LDF11996-03-15
GAQ11996-02-27
HRX11994-11-21
OCW11994-03-16
GCI11993-02-01
ETN11991-04-19
DXT11990-12-03
GDH11990-08-09
FBQ11990-04-04
ESZ11984-09-20
FMH11979-06-27
LFB11978-10-17

NDC#

200 records. Showing 1-40. Next

PMN#

110 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next