appliedmedical.comInzii Ripstop Redeployable Retrieval System
Applied Medical Resources Corporation
APPLIED MEDICAL RESOURCES CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2027111 | 2027111 | APPLIED MEDICAL RESOURCES CORP. | 1 | Y | 2026-01-01 | 22872 AVENIDA EMPRESA RSM CA US 92688 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00607915110123 | Epix Laparoscopic Scissors - 5mm x 35cm Laparoscopic Scissors | 1.949.713.8300 | contact@appliedmedical.com |
| 00607915110130 | Epix Laparoscopic Scissors - 5mm x 45cm Laparoscopic Scissors | 1.949.713.8300 | contact@appliedmedical.com |
| 00607915110147 | Epix Laparoscopic Grasper - 5mm x 35cm Disposable Grasper | 1.949.713.8300 | contact@appliedmedical.com |
| 00607915146498 | Suction Irrigation System - Probe and Valve with dual bag tubing, 5mmx33cm | 9497138300 | contact@appliedmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 5178 | 1111636336 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | FED | 1999-12-28 |
| 5178 | 1506564538 | K993135 | IMPLANTABLE CLIP FOR GENERAL SURGERY | FZP | 1999-12-01 |
| 5178 | 1542190659 | K991219 | C-FLEX URETERAL STENTS | FAD | 1999-06-21 |
| 5178 | 1527678944 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 5178 | 1248100587 | K973465 | LATIS GRAFT CLEANING CATHETER | DXE | 1998-02-19 |
| 5178 | 1529196059 | K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | DXE | 1997-03-28 |
| 5178 | 1377322711 | K963359 | INSUFFLATION NEEDLE | HET | 1996-09-24 |
| 5178 | 1833204696 | K962668 | AMR-ACV CLAMPS | DXC | 1996-11-04 |
| 5178 | 1059252139 | K950586 | AVD INTIMAX THROMBECTOMY CATHETER | DXE | 1995-05-15 |
| 5178 | 1638455619 | K950492 | ATRAUMAX SURGICAL CLAMP | DXC | 1995-05-08 |
| 5178 | 1977121392 | K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | LYK | 1995-02-10 |
| 5178 | 1077592249 | K944135 | UROLOGICAL GUIDWIRE | KNY | 1994-09-21 |
| 5178 | 1505856789 | K943489 | DISPOSABLE SURGICAL TROCAR | GCJ | 1994-08-09 |
| 5178 | 1140768919 | K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | EYB | 1994-04-18 |
| 5178 | 1140621589 | K932995 | SURGICAL TROCAR AND CANNULA | GCJ | 1993-09-23 |
| 5178 | 1144427289 | K931895 | ENDOSCOPE ACCESSORY | GCJ | 1993-09-07 |
| 5178 | 1650560157 | K923636 | TROCAR W/ BLUNT TIP OBTURATOR | HET | 1993-11-05 |
| 5178 | 1372061309 | K921838 | ACUCISE URETERAL CUTTING CATHETER | EYB | 1993-02-26 |
| 5178 | 1406317621 | K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | 1992-03-18 |
| 5178 | 1956717426 | K911181 | INTIMAX(TM) IRRIGATION CATHETER | GCA | 1991-04-18 |
| 5178 | 1353839459 | K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | FGE | 1991-03-28 |
| 5178 | 1843139089 | K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | 1991-04-26 |
| 5178 | 1055890976 | K910006 | AVD INTIMAX (TM) BILIARY CATHETER | FGE | 1991-02-13 |
| 5178 | 1430148382 | K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | 1991-03-21 |
| 5178 | 1104296000 | K903848 | DIAGNOSTIC INTRASCULAR CATHETER | DQO | 1991-03-25 |
| 5178 | 1549883341 | K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | DQY | 1991-02-15 |
| 5178 | 1395379831 | K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | DXC | 1990-07-06 |
| 5178 | 1019212085 | K901627 | ARTERIAL EMBOLECTOMY CATHETER | DXE | 1990-10-19 |
| 5178 | 1974658392 | K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | DXC | 1990-06-12 |
| 5178 | 2027106207 | K895691 | VASCULAR CLAMP | DXC | 1989-12-13 |
| 5178 | 1625189987 | K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | DXC | 1989-06-07 |
| 5178 | 1402810198 | K883909 | SURGICAL SPRING CLIPS | DSS | 1988-12-27 |
| 5178 | 1109723200 | K883790 | SURGICAL CLAMP INSERTS | DXC | 1988-12-27 |
| 5178 | 1291448936 | K880987 | INJECTOR HANDLE WITH SYRINGE | DXT | 1988-05-13 |
| 5178 | 1299351422 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | 2026-02-23 |
| 5178 | 1137517190 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | 2025-10-02 |
| 5178 | 1753392493 | K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | 2023-11-01 |
| 5178 | 1405388215 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | 2022-10-14 |
| 5178 | 1115965782 | K220969 | GelPOINT V-Path Vaginal Access System | MOK | 2022-09-16 |
| 5178 | 2031022648 | K211043 | Alexis Contained Extraction System | GCJ | 2022-03-31 |
| 5178 | 1165961951 | K202818 | Voyant Fine Fusion Device (EB230) | GEI | 2021-12-16 |
| 5178 | 1178856500 | K201212 | Voyant Open Fusion Device | GEI | 2020-06-05 |
| 5178 | 1492529352 | K200598 | Voyant Maryland Fusion Device | GEI | 2020-04-08 |
| 5178 | 1223552478 | K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | GEI | 2019-12-20 |
| 5178 | 1762308452 | K191866 | GelPOINT Mini Advanced Access Platform | GCJ | 2020-04-29 |
| 5178 | 1000114303 | K191294 | Transvaginal Access Platform | HEW | 2019-09-06 |
| 5178 | 1746619779 | K190331 | Applied Medical Laparoscopic Linear Cutter | GDW | 2019-11-22 |
| 5178 | 1596740812 | K182653 | Voyant Maryland Fusion Device | GEI | 2018-11-14 |
| 5178 | 1948034507 | K182244 | Voyant Electrosurgical Generator | GEI | 2018-10-11 |
| 5178 | 1119058631 | K182024 | Dissecting Balloon System | GCJ | 2018-08-30 |
| 5178 | 1875879990 | K180699 | Voyant Open Fusion Device | GEI | 2018-04-13 |
| 5178 | 1496533614 | K172624 | Voyant 5mm Fusion Device | GEI | 2018-02-13 |
| 5178 | 1020755010 | K171701 | GelPOINT Path Transanal Access Platform | FER | 2017-07-20 |
| 5178 | 1809521213 | K171684 | Epix Electrosurgical Probe with Smoke Evacuation | GEI | 2017-08-07 |
| 5178 | 1906981758 | K162676 | Voyant Open Fusion Device | GEI | 2016-12-01 |
| 5178 | 1322528095 | K153017 | Voyant Fine Fusion | GEI | 2016-07-06 |
| 5178 | 1422829029 | K151480 | Epix Electrosurgical Probe with Smoke Evacuation | GEI | 2016-02-19 |
| 5178 | 1339799956 | K143308 | GelPOINT Transvaginal Access Platform | HEW | 2015-10-13 |
| 5178 | 2043297367 | K142427 | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 | GCJ | 2014-12-23 |
| 5178 | 1695938854 | K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE | GEI | 2014-08-22 |
| 5178 | 1447531040 | K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | FER | 2014-01-02 |
| 5178 | 1073281940 | K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE | GEI | 2014-01-24 |
| 5178 | 1340184936 | K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | BTA | 2012-10-02 |
| 5178 | 1080976531 | K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | KGW | 2013-02-08 |
| 5178 | 1026734310 | K110792 | GELPOINT PATH | FER | 2011-05-23 |
| 5178 | 1184345470 | K103282 | LAPAROSCOPIC DISSECTOR | GEI | 2010-11-16 |
| 5178 | 1040792889 | K100959 | SPECIMEN RETRIEVAL SYSTEM | GCJ | 2010-04-22 |
| 5178 | 2068660443 | K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | KGW | 2010-04-02 |
| 5178 | 1562737732 | K093296 | ALEXIS LAPAROSCOPIC SYSTEM | KGW | 2009-11-05 |
| 5178 | 1894847465 | K090275 | GELPORT SINGLE INCISION ACCESS SYSTEM | GCJ | 2009-02-18 |
| 5178 | 1721005382 | K083638 | FIXATION TROCARS | GCJ | 2008-12-23 |
| 5178 | 2060383859 | K072674 | KII TROCAR SYSTEM | GCJ | 2007-10-05 |
| 5178 | 1404249633 | K062907 | ALEXIS WOUND RETRACTOR | KGW | 2007-01-09 |
| 5178 | 1867361539 | K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | HET | 2006-08-24 |
| 5178 | 1984965532 | K060673 | PEDIATRIC URETERAL STENT | FAD | 2006-03-29 |
| 5178 | 1777340991 | K060629 | GELPORT BLUNT TIP TROCAR SYSTEM | GCJ | 2006-04-07 |
| 5178 | 1544758685 | K060534 | INTUITIVE SURGICAL SEAL | GCJ | 2006-03-13 |
| 5178 | 1560083087 | K060096 | MODULAR TROCAR SYSTEM | GCJ | 2006-01-24 |
| 5178 | 2014348544 | K060051 | SPECIMEN RETRIEVAL SYSTEM | GCJ | 2006-01-19 |
| 5178 | 1426983339 | K041795 | MODIFICATION TO OPTICAL SEPARATOR SYSTEM | GCJ | 2004-09-14 |
| 5178 | 1388913102 | K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 | KGW | 2004-08-26 |
| 5178 | 1649681558 | K040760 | MODIFICATION TO URETERAL STENT | FAD | 2004-10-15 |
| 5178 | 1057625121 | K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | HET | 2004-03-12 |
| 5178 | 1811282318 | K032889 | OPTICAL SEPARATOR | GCJ | 2003-10-02 |
| 5178 | 1053799340 | K030642 | DEFLECTING URETERAL ACCESS SHEATH | FED | 2003-05-23 |
| 5178 | 1927675236 | K014047 | APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE | GCJ | 2002-02-28 |
| 5178 | 1582555126 | K011236 | MODIFICATION TO IMPLANTABLE CLIP | FZP | 2001-05-14 |
| 5178 | 1692084712 | K003443 | SUCTION IRRIGATOR | FHF | 2001-02-01 |
| 5178 | 1770073585 | K002915 | FLEXIBLE OCCLUSION SYSTEM | DXC | 2001-01-08 |
| 5178 | 1931945294 | ||||
| 5178 | 1298903903 | ||||
| 5178 | 1438209867 | ||||
| 5178 | 1593217243 | ||||
| 5178 | 1685343469 | ||||
| 5178 | 1906335858 | ||||
| 5178 | 1927103602 | ||||
| 5178 | 2010298733 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GCJ | 19 | 2023-11-01 |
| GEI | 16 | 2022-10-14 |
| DXC | 8 | 2001-01-08 |
| KGW | 6 | 2026-02-23 |
| DXE | 5 | 1998-02-19 |
| HET | 4 | 2006-08-24 |
| HEW | 3 | 2025-10-02 |
| FER | 3 | 2017-07-20 |
| FAD | 3 | 2006-03-29 |
| FGE | 3 | 1991-03-28 |
| FED | 2 | 2003-05-23 |
| FZP | 2 | 2001-05-14 |
| EYB | 2 | 1994-04-18 |
| MOK | 1 | 2022-09-16 |
| GDW | 1 | 2019-11-22 |
| BTA | 1 | 2012-10-02 |
| FHF | 1 | 2001-02-01 |
| FMF | 1 | 1998-06-11 |
| LYK | 1 | 1995-02-10 |
| KNY | 1 | 1994-09-21 |
| ODC | 1 | 1992-03-18 |
| GCA | 1 | 1991-04-18 |
| DQO | 1 | 1991-03-25 |
| DQY | 1 | 1991-02-15 |
| DSS | 1 | 1988-12-27 |
| DXT | 1 | 1988-05-13 |
PMN#
Voyant Maryland Fusion Device With Single-Step Activation (EB212, EB213, EB214)
Applied Medical Resources Corporation
GelPOINT V-Path Vaginal Access System
Applied Medical Resources Corporation
Alexis Contained Extraction System
Applied Medical Resources Corporation
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applied Medical Resources Corporation
Applied Medical Anoscope
Applied Medical Resources
Voyant Open Fusion Device
Applied Medical Resources Corp.
Voyant Maryland Fusion Device
Applied Medical Resources Corp.
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
Applied Medical Resources Corp.
Applied Medical Laparoscopic Linear Cutter
Applied Medical Resources Corporation
Transvaginal Access Platform
Applied Medical Resources Corp.
Voyant Maryland Fusion Device
Applied Medical Resources Corp.
Voyant Electrosurgical Generator
Applied Medical Resources Corp.
Dissecting Balloon System
Applied Medical Resources Corp.
Voyant Open Fusion Device
Applied Medical Resources Corporation
Voyant 5mm Fusion Device
Applied Medical Resources Corporation
Epix Electrosurgical Probe With Smoke Evacuation
Applied Medical Resources Corporation
GelPOINT Path Transanal Access Platform
Applied Medical Resources Corp.
Voyant Open Fusion Device
Applied Medical Resources
Voyant Fine Fusion
APPLIED MEDICAL RESOURCES
Voyant Open Fusion Device
APPLIED MEDICAL RESOURCES
Epix Electrosurgical Probe With Smoke Evacuation
APPLIED MEDICAL RESOURCES
GelPOINT Transvaginal Access Platform
APPLIED MEDICAL RESOURCES
Voyant Fine Fusion Device
APPLIED MEDICAL RESOURCES
Voyant Open Sealer-Divider Device
APPLIED MEDICAL RESOURCES
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
APPLIED MEDICAL RESOURCES
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
APPLIED MEDICAL RESOURCES
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
APPLIED MEDICAL RESOURCES CORP.
GELPOINT PATH TRANSANAL ACCESS PLATFORM
APPLIED MEDICAL RESOURCES CORP.
ALEXIS O WOUND PROTECTOR/RETRACTOR
APPLIED MEDICAL RESOURCES CORP.
GELPOINT PATH
APPLIED MEDICAL RESOURCES CORP.
LAPAROSCOPIC DISSECTOR
APPLIED MEDICAL RESOURCES CORP.
SPECIMEN RETRIEVAL SYSTEM
APPLIED MEDICAL RESOURCES
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
APPLIED MEDICAL RESOURCES CORP.
ALEXIS LAPAROSCOPIC SYSTEM
APPLIED MEDICAL RESOURCES CORP.
GELPORT SINGLE INCISION ACCESS SYSTEM
APPLIED MEDICAL RESOURCES CORP.
FIXATION TROCARS
APPLIED MEDICAL RESOURCES CORP.
KII TROCAR SYSTEM
APPLIED MEDICAL RESOURCES CORP.
INTRAVASCULAR INTRODUCER SYSTEM
APPLIED MEDICAL RESOURCES CORP.
ALEXIS WOUND RETRACTOR
APPLIED MEDICAL RESOURCES
GUDID#
Epix Laparoscopic Scissors - 5mm x 35cm Laparoscopic Scissors
2016-09-24
Epix Laparoscopic Scissors - 5mm x 45cm Laparoscopic Scissors
2016-09-24
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.
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.
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.
2026-04-22
Suction Irrigation System - Probe and Valve with dual bag tubing, 5mmx33cm
2024-02-01
Suction Irrigation System - Valve with dual bag tubing.
2024-02-01
Epix Laparoscopic Grasper - 5mm x 35cm Disposable Grasper
2016-08-30
Epix Laparoscopic Grasper - 5mm x 45cm Disposable Grasper
2016-08-30
Direct Drive Reposable Graspers - 38cm Reposable Grasper Cartridge
2016-08-30
Direct Drive Reposable Graspers - 45cm Reposable Grasper Cartridge
2016-08-30
Inzii Retrieval System - Tissue Retrieval System, 12/15mm
2016-09-24
Inzii Ripstop Retrieval System - 12/15mm Ripstop Retrieval System
2026-01-16
Epix ® Laparoscopic Dissector - 5mm x 35cm Disposable Dissector
2016-09-24
Inzii Retrieval System - Tissue Retrieval System, 10mm
2016-09-24
Inzii Retrieval System - Universal Tissue Retrieval System
2016-09-24
Epix® Reusable Probe - 5mm x 33cm Reusable Probes with irrigation holes
2016-08-19
Epix® Reusable Probe - 5mm x 45cm Reusable probe with irrigation holes.
2016-08-19
Epix® Reusable Probe - 10mm x 33cm Reusable Probes with irrigation holes.
2016-08-19
Epix® Reusable Probe - 5mm x 33cm Reusable Pool tip probes.
2016-08-19
Voyant Electrosurgical Generator - EA030
2026-01-16
Epix 10mm Clip Applier - Disposable Laparoscopic Clip Applier with 20 Clips.
2025-10-27
GelPort® Hand Access Laparoscopic System - Access Platform for minimally invasive surgery.
2016-08-25
Epix Electrosurgical Probe with Smoke Evacuation - L-Hook - 5mm x 42cm - Angled Shaft - L-hook Tip
2018-06-26
Epix Electrosurgical Probe with Smoke Evacuation - Angled Spatula Tip - 5mm x 42cm - Angled Shaft - Spatula Tip
2018-10-05
Epix Electrosurgical Probe with Smoke Evacuation - Angled Needle Tip - 5mm x 42cm - Angled Shaft - Needle Tip
2018-10-05
Epix Electrosurgical Probe with Smoke Evacuation - Straight Spatula Tip - 5mm x 42cm - Straight Shaft - Spatula Tip
2019-08-28
Epix Electrosurgical Probe with Smoke Evacuation -Straight L-Hook - 5mm x 42cm - Straight Shaft - L-hook Tip
2019-08-28
Epix Electrosurgical Probe with Smoke Evacuation - Straight Needle Tip - 5mm x 42cm - Straight Shaft - Needle Tip
2019-08-28
Inzii Ripstop Redeployable Retrieval System - Redeployable tissue retrieval system with Ripstop nylon bag.
2024-03-19
Alexis ® Orthopaedic Protector - Disposable Orthopaedic Protector
2016-09-23
Alexis® Orthopaedic Protector - Flexible Alexis Orthopaedic Protector
2018-08-13
Alexis® Orthopaedic Protector - Flexible Alexis Orthopaedic Protector
2018-08-13
Alexis® Orthopaedic Protector - Flexible Alexis Orthopaedic Protector
2018-08-13
Alexis® Orthopaedic Protector - Flexible Alexis Orthopaedic Protector
2024-07-11
Alexis ® O C-Section Protector - Retractor - Large, Disposable Alexis O C-Section Protector - Retractor
2016-09-24
Alexis ® O C-Section Protector - Retractor - Extra Large, Disposable C-Section Protector - Retractor
2016-09-24
Alexis ® O C-Section Protector-Retractor - Large, Disposable C-Section Retractor
2016-09-24
Alexis ® O C-Section Protector-Retractor - Extra Large, Disposable C-Section Retractor
2016-09-24
Alexis Laparoscopic System - Laparoscopic Access System
2016-09-24