FDA.report

Endo

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10561291000132436ENDO-THERAPEUTICS, INC.1Y2026-01-0115251 Roosevelt Blvd Ste 204 CLEARWATER FL US 33760
12259683002480801ENDOCRAFT LLC.1N2026-01-01100 Bellevue St Newton MA US 02458
14237143000719482ENDOPLUS1N2026-01-01750 Tower Rd Ste A Mundelein IL US 60060
22438422243842ENDO USA1N2026-01-018 CLARKE DR. Cranbury NJ US 08512
30070204143007020414ENDO-SYSTEMS LLC1Y2026-01-012966 NW 60 Street Ft Lauderdale FL US 33309
30080112473008011247Endologix LLC1N2026-01-013910 Brickway Blvd Santa Rosa CA US 95403
30091262543009126254ENDOSCOPY SPECIALISTS, INC.1Y2026-01-011011 Shotgun Road Sunrise FL US 33326
30110632233011063223Endologix LLC1N2026-01-0135 Hammond Irvine CA US 92618
30113981623011398162ENDO-PASSION GMBH1N2026-01-01Faulenbachstr. 15 Wurmlingen Baden-Wurttemberg DE 78573
30114522183011452218ENDOSYS HEALTHCARE INDIA PVT. LTD1N2026-01-0192-C, Govt. Industrial Estate, Opp. Sahyadri Nagar, Kandivali West, Mumbai Maharashtra IN 400067
30126444263012644426ENDOMAGNETICS LTD1N2026-01-01330 Cambridge Science Park Milton Road Cambridge Cambridgeshire GB CB4 0WN
30143088163014308816ENDONOVO THERAPEUTICS1N2026-01-016320 Canoga Avenue, 15h Floor Woodland Hills CA US 91367
30153659043015365904Endologix LLC1N2026-01-011971 Milmont Dr Milpitas CA US 95035
30162486343016248634ENDOMED, LLC1Y2026-01-013505 Lake Lynda Dr Suite 200 Orlando FL US 32817
30164639053016463905ENDOGI MEDICAL, LTD.1N2026-01-01Wadi El Haj 13 Nazareth Northern IL 17111
30179689933017968993ENDOSOUND INC1N2026-01-014640 S Macadam Ave Ste 200 Portland OR US 97239
30195678083019567808ENDOPERFECTION LTD1N2026-01-01Unit 3 The Triangle Wildwood Drive Worcester Worcestershire GB WR5 2QX
30217218053021721805ENDO TOOLS THERAPEUTICS S.A1N2026-01-01Allee de la Recherche, 12 Anderlecht Brussels-Capital Region BE 1070
30227642783022764278EndoTheia, Inc.1N2026-01-011720 W End Ave Ste 520 Nashville TN US 37203
30249859333024985933ENDOTRONIX (Naperville)1N2026-01-011415 WEST DIEHL ROAD Suite 500 Naperville IL US 60563
30265679633026567963ENDOVASCULAR ENGINEERING, INC.1N2026-01-013925 Bohannon Drive Suite 300 Menlo Park CA US 94025
30266719983026671998ENDOLUMIK1N2026-01-01364 Patteson Dr. #293 Morgantown WV US 26505
30273445703027344570ENDO DIRECT, LLC1N2026-01-0124 Abeel Rd Monroe NJ US 08831
30312763123031276312ENDOFIX MEDICAL TECHNOLOGIES1N2026-01-01111 Washington St. Suite 201i Plainville MA US 02762
30421586723042158672ENDOSEMIO CO., LTD.1N2026-01-012F.-3, No. 6-1, Sec. 2, Shengyi Rd., Zhubei City Hsinchu TW 302058

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
10816207021741EndoTExtractor - Endoscopic retrieval device844-400-3636customerservice@endotherapeutics.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3106641769930661P230040Cordella Pulmonary Artery Sensor System (CorPASS)MOM2024-06-20
2242361993117952P220021DETOUR SystemQWM2023-06-07
3184651993117952P220021DETOUR SystemQWM2023-06-07
3455431087706653P160053MagtraceTM and Sentimag(R) Magnetic Locatization SystemPUV2018-07-24
2242361962862557P120006OVATION ABDOMINAL STENT GRAFT SYSTEMMIH2012-10-05
1753601433534800P040002ENDOLOGIX POWERLINK SYSTEMMIH2004-10-29
1753601301735027K991601DUAL LUMEN CATHETER, MODEL DL-35-90DQY1999-10-28
461752035497333K925392BIOPSY FORCEPSFCL1993-11-05
744481173742438K925114LAPAROSCOPIC INSTRUMENTSHFI1994-02-28
744481010339775K925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)HET1994-08-24
461751367967973K800976M.R. ASSOC. W TYPE GRASPING FORCEPSOCZ1980-05-08
461751356805673K800973M.R. ASSOC. HOT BIOPSY FORCEPSKNS1980-05-08
461752025269203K800972M.R. ASSOC. TRIPOD GRASPING FORCEPSOCZ1980-05-08
461751824392172K800970M.R. ASSOC. BASKET RETRIEVERSOCZ1980-05-08
461751260831023K800968M.R. ASSOC. RAT TOOTH GRASP FORCEPSOCZ1980-05-08
461751362703805K800967M.R. ASSOC. ALLIGATOR GRASPONG FORCEPSOCZ1980-05-08
461752057463651K800966M.R. ASSOC. CYTOLOGY BRUSHESFDX1980-05-08
461751782902546K800965M.R. ASSOC. SNARES; CRESCENT SNARE WIREKNS1980-05-08
3149502017946754K252956Helo Thrombectomy SystemQEW2025-12-18
3025901536889924K252400Endomina EZFuse systemOCW2026-02-13
3441691762993956K251229EndoFix™Tissue Fixation SystemFGE2025-08-20
3246331308521362K250145Biopsy Port AdapterODC2025-10-17
3175272021417259K241457Vista BC PuttyKIF2024-08-28
3152941811154553K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)KNT2024-02-08
3455431871797829K232865Magseed Pro Magnetic Marker SystemNEU2024-06-28
2807901596067805K232596EndoGI S-Path Biliary Stent SystemFGE2023-09-27
3246331261675962K232518EndoSound Vision System; EVSODG2023-12-27
2374311119086776K232373Progrip™ Self-Gripping Polypropylene MeshFTL2024-01-18
3149502049736786K223891Cobra Catheter SystemQEW2023-02-15
3152941228626990K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)KNT2023-03-03
3455431830109306K222832Sentimag SystemNEU2023-01-21
3175271239054465K221811Vista BC SealerKIF2022-11-21
3025901541815072K211309endomina systemOCW2021-12-07
2374311880377706K2008183DMax MID Anatomical MeshFTL2020-07-17
2807901520277234K193600EndoGI Biliary Stent SystemFGE2020-06-26
3175271265434110K193409Vista Rinse, Vista Rinse PlusKJJ2020-09-09
3455431916766950K173587Magseed Magnetic Marker SysttemNEU2018-02-16
2374311282647834K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedGEI2017-04-21
3455431243372140K163541Magseed Magnetic Marker SystemPBY2017-01-13
2374311804269555K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedGEI2016-11-14
2374311197983819K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedGEI2016-09-15
3455431410986230K153044Sentimag System, Sentimark Magnetic Marker SystermPBY2016-03-02
744481064929965K151567ENDOPLUS hand-held laparoscopic instrumentsHFI2015-12-23
2374311206901557K150068Unimicro Veress NeedleHIF2015-07-31
2374311042372187K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite MeshFTL2014-11-14
2374311444763347K142208Monopolar Laparascopic AccessoriesGEI2015-04-13
2374311989129142K141594Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless TrocarGCJ2015-08-10
2374312046742924K141593UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCHGCJ2014-11-13
2374311744424897K141592UNIMICRO SUCTION IRRIATION TUBING SETGCJ2014-08-04
461751405395765K132809INSTINCT ENDOSCOPIC HEMOCLIPPKL2013-10-25
2374311616584554K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRGDW2013-07-05
2374312030564597K123109ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICEGDW2012-10-23
2154051835448160K121338ZEOBIILX2012-07-27
1753601587415105K120212AFX INTRODUCER SYSTEMDYB2012-02-09
3175271216885492K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAKJJ2009-04-03
2154051208711528K070541IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO IIILX2008-12-11
461751527622967K012977VARICES INJECTION NEEDLEFBK2001-11-02
2242361097912016H100008
2374311065426536
2374311131276576
2374311272671029
2374311305493448
2374311321887047
2374311323801694
2374311344583421
2374311410130003
2374311540298397
2374311663063332
2374311704927916
2374311714388387
2374311728836696
2374311741761168
2374311795741882
461751804925737
2374311824348183
2374311824577064
2374311862371655
2374311899659022
2374311907967467
2374311954058511
2374311976141114
3246331035911560
3455431051975303
553151118184149
3175271134445096
2920961136538919
2886571154275754
2920961195598067
553151202925340
2920961206792928
3389091221330896
2374311235928449
553151253084667
1812551256335885
3175271278126079
2374311286119222
3175271308324293
2374311351795056
2374311370737334
553151373872883
3175271389952792
461751391347144
2886571397241414
461751422369519
3434181474921399
2374311477190262
744481481760166
553151493052698
3175271509636984
2886571517698059
3152941528902439
2920961563224607

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OCZ51980-05-08
GEI42017-04-21
FGE32025-08-20
NEU32024-06-28
FTL32024-01-18
GCJ32015-08-10
OCW22026-02-13
QEW22025-12-18
KIF22024-08-28
KNT22024-02-08
KJJ22020-09-09
PBY22017-01-13
HFI22015-12-23
GDW22013-07-05
MIH22012-10-05
ILX22012-07-27
KNS21980-05-08
ODC12025-10-17
ODG12023-12-27
PUV12018-07-24
HIF12015-07-31
PKL12013-10-25
DYB12012-02-09
FBK12001-11-02
DQY11999-10-28
HET11994-08-24
FCL11993-11-05
FDX11980-05-08

NDC

120 records. Showing 1-40. Next

PMA

Alto Abdominal Stent Graft System

2022-12-22

Endologix, LLC3910 Brickway Blvdsanta Rosa, CA 95403 PMA NumberP120006 Supplement NumberS041 Date Received12/02/2022 Decision Date12/22/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - ...

AFX2 Endovascular AAA System

2022-12-06

Endologix, LLC2 Musickirvine, CA 92618 PMA NumberP040002 Supplement NumberS070 Date Received03/15/2022 Decision Date12/06/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indica...

MagtraceTM and Sentimag(R) Magnetic Locatization System

2022-09-13

ENDOMAGNETICS LTD.330 Cambridge Science Park, Milton Roadcambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Tra...

79 records. Showing 1-40. Next

PMN

EndoClot

2021-01-29

EndoClot Plus Co., Ltd.

EndoClot

2020-01-30

EndoClot Plus Co., Ltd.

EndoClot

2017-01-18

EndoClot Plus Co., Ltd.

200 records. Showing 1-40. Next

Applications

761146

ENDO GLOBAL AESTHETICS LTD

GUDID

80 records. Showing 1-40. Next