FDA.reportPublic FDA data

APPLIED MEDICAL TECHNOLOGY, INC.

Matched from indexed company URL: Applied Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15260121526012APPLIED MEDICAL TECHNOLOGY, INC.1N2026-01-018006 Katherine Blvd Brecksville OH US 44141
20271112027111APPLIED MEDICAL RESOURCES CORP.1Y2026-01-0122872 AVENIDA EMPRESA RSM CA US 92688
30090518883009051888Applied Medical Distribution Center1Y2026-01-019401 Toledo Way Irvine CA US 92618
30097630193009763019Applied Medical Europe1N2026-01-01Wiekenweg 21 Amersfoort Utrecht NL 3815 KL
30103538673010353867APPLIED MEDICAL COATINGS1N2026-01-01230 South Niagara Street Lockport NY US 14094

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
00607915110123Epix Laparoscopic Scissors - 5mm x 35cm Laparoscopic Scissors1.949.713.8300contact@appliedmedical.com
00607915110130Epix Laparoscopic Scissors - 5mm x 45cm Laparoscopic Scissors1.949.713.8300contact@appliedmedical.com
00842071147198MINI Balloon Button - 24FR x 2.7 cm MINI Balloon Button Kit, MDR(440)717-4000cs@appliedmedical.net
00842071147204MINI Balloon Button - 24FR x 2.7 cm MINI Balloon Button Kit (ENFit), MDR(440)717-4000cs@appliedmedical.net
00842071153045AMT MiniSPC Drainage Set - "12"" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched), MDR"(440)717-4000cs@appliedmedical.net
00842071153069AMT MiniSPC Drainage Set - "24"" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched), MDR"(440)717-4000cs@appliedmedical.net
00842071153144AMT MiniONE Extension Set - "24"" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR"(440) 717-4000cs@appliedmedical.net

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
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
51781137517190K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02
1517761137517190K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02
318861431771008K241111AMT Suture PasserGCJ2024-07-05
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
51782031022648K211043Alexis Contained Extraction SystemGCJ2022-03-31
1517762031022648K211043Alexis Contained Extraction SystemGCJ2022-03-31
1787482031022648K211043Alexis Contained Extraction SystemGCJ2022-03-31
51781165961951K202818Voyant Fine Fusion Device (EB230)GEI2021-12-16
1517761165961951K202818Voyant Fine Fusion Device (EB230)GEI2021-12-16
318861217449433K202539Nutriglide(TM) Nasal Feeding TubeKNT2020-10-29

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
KGC32020-03-12
GDW32019-11-22
BTA32012-10-02
FHF32001-02-01
FMF31998-06-11
LYK31995-02-10
KNY31994-09-21
ODC31992-03-18
DQO31991-03-25
DSS31988-12-27
DXT31988-05-13
MOK22022-09-16
CCK22014-11-24
GCA21991-04-18
DQY21991-02-15
QVS12026-02-03
KOB12024-11-01
PIO12015-06-09
PIF12015-01-29

PMN#

200 records. Showing 1-40. Next

GUDID#

Alexis® Lighted Wound Protector-Retractor - The Alexis Lighted Wound Protector-Retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The Alexis Lighted Wound Protector-Retractor is capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, the device may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.

APPLIED MEDICAL RESOURCES CORPORATION

2026-04-22

Alexis® Lighted Wound Protector-Retractor - The Alexis Lighted Wound Protector-Retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The Alexis Lighted Wound Protector-Retractor is capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, the device may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.

APPLIED MEDICAL RESOURCES CORPORATION

2026-04-22

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device - The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insuffiation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens.

APPLIED MEDICAL RESOURCES CORPORATION

2026-04-22

80 records. Showing 1-40. Next