APPCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15260121526012APPLIED MEDICAL TECHNOLOGY, INC.1N2026-01-018006 Katherine Blvd Brecksville OH US 44141
18313011831301APPLIED LABORATORIES, INC.1N2026-01-013240 N. Indianapolis Rd. COLUMBUS IN US 47201
20271112027111APPLIED MEDICAL RESOURCES CORP.1Y2026-01-0122872 AVENIDA EMPRESA RSM CA US 92688
29512751000221351APPLIED SCIENCE, INC.1N2026-01-01983 GOLDEN GATE TERRACE GRASS VALLEY CA US 95945
29547053002979697APPLIED DENTAL INC. DBA AD Surgical1Y2026-01-011296 Kifer Road Suite 608 Sunnyvale CA US 94086
30026910993002691099Applied Spectral Imaging Inc.1Y2026-01-016160 Innovation Way Carlsbad CA US 92008
30045775963004577596Applied Neuroscience, Inc.1N2026-01-01248 176TH TERRACE DR E REDINGTON SHORES FL US 33708
30077992343007799234Applied BioCode, Inc.1N2026-01-0112130 Mora Drive Unit #2 Santa Fe Springs CA US 90670
30084773523008477352Applied Biosystems1Y2026-01-017302 Governors Way Frederick MD US 21704
30090518883009051888Applied Medical Distribution Center1Y2026-01-019401 Toledo Way Irvine CA US 92618
30094917383009491738APPLIED TECHNOLOGY INTERNATIONAL, LTD DBA:FABRIFOAM PRODUCTS1N2026-01-01900 Springdale Dr Exton PA US 19341
30097630193009763019Applied Medical Europe1N2026-01-01Wiekenweg 21 Amersfoort Utrecht NL 3815 KL
30101636953010163695APPLIMED SA -CSSR1N2026-01-01Route de Pra de Plan 3 Ch�tel St Denis Fribourg CH 1618
30103538673010353867APPLIED MEDICAL COATINGS1N2026-01-01230 South Niagara Street Lockport NY US 14094
30106899583010689958Applied BioPhotonics Ltd.1N2026-01-011F, No. 167, Fu-Hsing 3rd Road ChuPei City Hsinchu TW 302
30111109133011110913APPASAMY ASSOCIATES PRIVATE LIMITED (MN KUPPAM)1N2026-01-01S.F.No. 144/1, Navammal Kapper Village, M.N.Kuppam, Thennal Post, Kandamangalam Taluk, Villupuram District Tamil Nadu IN 605102
30135758583013575858APPASAMY ASSOCIATES PRIVATE LIMITED ( THIRUBHUVANAI))1N2026-01-01R. S. No: 25 / 1 & 3, Thirubuvanai Village, Mannadipet Commune Puducherry IN 605107
30143439543014343954APPLE INC.1N2026-01-01One Apple Park Way Cupertino CA US 95014
30150469343015046934Applied Biosystems1Y2026-01-016433 English Muffin Way Frederick MD US 21703
30210715683021071568APPLIEDVR1N2026-01-0116760 Stagg St Unit 216 Van Nuys CA US 91406
30301813183030181318APPLY LABWORK INC.1N2026-01-01No. 1, Ln. 277, Fulian Rd., Yangmei Dist. Taoyuan City TW 326005
30321917073032191707APPLIED PHOTONIX LLC1N2026-01-013802 Spectrum Blvd suite 202 Tampa FL US 33612
30079578423007957842Apple Biomedical Inc1N2020-04-258F, No.12, Lane 609 , Chong Shin Road, Sec. 5, SanChong Dist New Taipei City Taipei - Special Municip TW 24159
30093918813009391881Applied Botanics dba Method Seven1Y2020-04-251010 Fair Ave Suite F Santa Cruz CA US 95060
30095184293009518429APPLIED TISSUE TECHNOLOGIES LLC1N2020-04-2599 Derby Street Suite 200 Hingham MA US 02043

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
51781111636336K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
1517761111636336K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
1787481111636336K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
51781506564538K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
1517761506564538K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
1787481506564538K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
51781542190659K991219C-FLEX URETERAL STENTSFAD1999-06-21
1517761542190659K991219C-FLEX URETERAL STENTSFAD1999-06-21
1787481542190659K991219C-FLEX URETERAL STENTSFAD1999-06-21
51781527678944K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1517761527678944K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1787481527678944K980987BECTON DICKINSON SYRINGEFMF1998-06-11
318861198153220K980305AMT BUTTON REPLACEMENT GASTROSTOMY DEVICEKNT1998-04-16
318861084948761K980145AMT DECOMPRESSION TUBESKGC1998-04-10
318862002721481K973893AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAEKNT1997-12-19
51781248100587K973465LATIS GRAFT CLEANING CATHETERDXE1998-02-19
1517761248100587K973465LATIS GRAFT CLEANING CATHETERDXE1998-02-19
318862028272970K971758CAUTERIZATION SMOKE EVACUATORGEI1997-07-21
318861199081278K971757LOW PROFILE FEEDING SET ACCESSORYKNT1997-11-07
318861052959077K971434A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICEKNT1998-08-17
51781529196059K970762DUAL LUMEN EMBOLECTOMY CATHETERDXE1997-03-28
1517761529196059K970762DUAL LUMEN EMBOLECTOMY CATHETERDXE1997-03-28
51781377322711K963359INSUFFLATION NEEDLEHET1996-09-24
1517761377322711K963359INSUFFLATION NEEDLEHET1996-09-24
1787481377322711K963359INSUFFLATION NEEDLEHET1996-09-24
51781833204696K962668AMR-ACV CLAMPSDXC1996-11-04
1517761833204696K962668AMR-ACV CLAMPSDXC1996-11-04
1787481833204696K962668AMR-ACV CLAMPSDXC1996-11-04
318861999433006K960232ENDOSCOPIC ACCESS DEVICEGCJ1996-03-21
51781059252139K950586AVD INTIMAX THROMBECTOMY CATHETERDXE1995-05-15
1517761059252139K950586AVD INTIMAX THROMBECTOMY CATHETERDXE1995-05-15
51781638455619K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
1517761638455619K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
1787481638455619K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
318861777870586K945618GASTROINTESTINAL TUBES & ACCESSORIESKNT1995-10-12
51781977121392K945591APPLIED MEDICAL OPTICAL VALVULOTOMELYK1995-02-10
1517761977121392K945591APPLIED MEDICAL OPTICAL VALVULOTOMELYK1995-02-10
1787481977121392K945591APPLIED MEDICAL OPTICAL VALVULOTOMELYK1995-02-10
51781077592249K944135UROLOGICAL GUIDWIREKNY1994-09-21
1517761077592249K944135UROLOGICAL GUIDWIREKNY1994-09-21
1787481077592249K944135UROLOGICAL GUIDWIREKNY1994-09-21
51781505856789K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
1517761505856789K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
1787481505856789K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
51781140768919K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYB1994-04-18
1517761140768919K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYB1994-04-18
1787481140768919K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYB1994-04-18
51781140621589K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1517761140621589K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1787481140621589K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
51781144427289K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
1517761144427289K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
1787481144427289K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
51781650560157K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
1517761650560157K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
1787481650560157K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
51781372061309K921838ACUCISE URETERAL CUTTING CATHETEREYB1993-02-26
1517761372061309K921838ACUCISE URETERAL CUTTING CATHETEREYB1993-02-26
1787481372061309K921838ACUCISE URETERAL CUTTING CATHETEREYB1993-02-26
51781406317621K920030SURESEAL ENDOSCOPIC VALVEODC1992-03-18
1517761406317621K920030SURESEAL ENDOSCOPIC VALVEODC1992-03-18
1787481406317621K920030SURESEAL ENDOSCOPIC VALVEODC1992-03-18
51781956717426K911181INTIMAX(TM) IRRIGATION CATHETERGCA1991-04-18
1517761956717426K911181INTIMAX(TM) IRRIGATION CATHETERGCA1991-04-18
51781353839459K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERFGE1991-03-28
1517761353839459K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERFGE1991-03-28
51781843139089K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
1517761843139089K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
51781055890976K910006AVD INTIMAX (TM) BILIARY CATHETERFGE1991-02-13
1517761055890976K910006AVD INTIMAX (TM) BILIARY CATHETERFGE1991-02-13
51781430148382K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGE1991-03-21
1517761430148382K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGE1991-03-21
1787481430148382K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGE1991-03-21
51781104296000K903848DIAGNOSTIC INTRASCULAR CATHETERDQO1991-03-25
1517761104296000K903848DIAGNOSTIC INTRASCULAR CATHETERDQO1991-03-25
1787481104296000K903848DIAGNOSTIC INTRASCULAR CATHETERDQO1991-03-25
51781549883341K902256IRRIGATION CATHETER 4, 6 AND 10 FRENCHDQY1991-02-15
1517761549883341K902256IRRIGATION CATHETER 4, 6 AND 10 FRENCHDQY1991-02-15
51781395379831K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
1517761395379831K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
1787481395379831K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
51781019212085K901627ARTERIAL EMBOLECTOMY CATHETERDXE1990-10-19
1517761019212085K901627ARTERIAL EMBOLECTOMY CATHETERDXE1990-10-19
51781974658392K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
1517761974658392K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
1787481974658392K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
51782027106207K895691VASCULAR CLAMPDXC1989-12-13
1517762027106207K895691VASCULAR CLAMPDXC1989-12-13
1787482027106207K895691VASCULAR CLAMPDXC1989-12-13
51781625189987K891296ATRAUMAX(TM) SURGICAL CLAMPSDXC1989-06-07
1517761625189987K891296ATRAUMAX(TM) SURGICAL CLAMPSDXC1989-06-07
1787481625189987K891296ATRAUMAX(TM) SURGICAL CLAMPSDXC1989-06-07
51781402810198K883909SURGICAL SPRING CLIPSDSS1988-12-27
1517761402810198K883909SURGICAL SPRING CLIPSDSS1988-12-27
1787481402810198K883909SURGICAL SPRING CLIPSDSS1988-12-27
51781109723200K883790SURGICAL CLAMP INSERTSDXC1988-12-27
1517761109723200K883790SURGICAL CLAMP INSERTSDXC1988-12-27
1787481109723200K883790SURGICAL CLAMP INSERTSDXC1988-12-27
51781291448936K880987INJECTOR HANDLE WITH SYRINGEDXT1988-05-13
1517761291448936K880987INJECTOR HANDLE WITH SYRINGEDXT1988-05-13
1787481291448936K880987INJECTOR HANDLE WITH SYRINGEDXT1988-05-13
2230041153812030K253582Medical Imaging Calibration Feature (MICF)SHN2026-04-01
51781299351422K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)KGW2026-02-23
1517761299351422K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)KGW2026-02-23
318861555408189K252438Explant ExpressQVS2026-02-03
2230041921451238K250507Hypertension Notification Feature (HTNF)SFR2025-09-11
2230041954038347K250143Digital Prism Correction Feature (DPCF)SCW2025-06-23
2997341736799771K243417RelieVRxQRA2024-12-04
51781137517190K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02
1517761137517190K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02
3309971422097220K241140ViroZap Indoor Air Purifier, In Duct Model 1008FRA2024-08-01
318861431771008K241111AMT Suture PasserGCJ2024-07-05
2230041683458831K240929Sleep Apnea Notification Feature (SANF)QZW2024-09-13
318861129833489K240514AMT Low-Profile Suprapubic Catheter & Drainage SetKOB2024-11-01
51781753392493K232880Inzii Ripstop Redeployable Retrieval SystemGCJ2023-11-01
1517761753392493K232880Inzii Ripstop Redeployable Retrieval SystemGCJ2023-11-01
51781405388215K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI2022-10-14
1517761405388215K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI2022-10-14
51781115965782K220969GelPOINT V-Path Vaginal Access SystemMOK2022-09-16
1517761115965782K220969GelPOINT V-Path Vaginal Access SystemMOK2022-09-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ552024-07-05
GEI432022-10-14
DXC242001-01-08
KNT182020-10-29
KGW172026-02-23
HET122006-08-24
DXE101998-02-19
FER92017-07-20
FAD92006-03-29
HEW82025-10-02
FGE71991-03-28
FED62003-05-23
FZP62001-05-14
EYB61994-04-18
NUC52018-08-01
QDB32022-06-03
KGC32020-03-12
GDW32019-11-22
BTA32012-10-02
LJT32008-03-07
FHF32001-02-01
FMF31998-06-11
LYK31995-02-10
KNY31994-09-21
ODC31992-03-18
DQO31991-03-25
DSS31988-12-27
DXT31988-05-13
QRA22024-12-04
MOK22022-09-16
QDA22020-10-08
FRO22019-09-12
OMP22019-07-02
PCH22019-06-05
CCK22014-11-24
OLU22004-08-03
GCA21991-04-18
DQY21991-02-15
SHN12026-04-01
QVS12026-02-03

NDC#

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#