Voyant Maryland Fusion Device With Single-Step Activation (EB212, EB213, EB214)
Applied Medical Resources Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1526012 | 1526012 | APPLIED MEDICAL TECHNOLOGY, INC. | 1 | N | 2026-01-01 | 8006 Katherine Blvd Brecksville OH US 44141 |
| 2027111 | 2027111 | APPLIED MEDICAL RESOURCES CORP. | 1 | Y | 2026-01-01 | 22872 AVENIDA EMPRESA RSM CA US 92688 |
| 3009051888 | 3009051888 | Applied Medical Distribution Center | 1 | Y | 2026-01-01 | 9401 Toledo Way Irvine CA US 92618 |
| 3009763019 | 3009763019 | Applied Medical Europe | 1 | N | 2026-01-01 | Wiekenweg 21 Amersfoort Utrecht NL 3815 KL |
| 3010353867 | 3010353867 | APPLIED MEDICAL COATINGS | 1 | N | 2026-01-01 | 230 South Niagara Street Lockport NY US 14094 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 5178 | 1111636336 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | FED | 1999-12-28 |
| 151776 | 1111636336 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | FED | 1999-12-28 |
| 178748 | 1111636336 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | FED | 1999-12-28 |
| 178748 | 1506564538 | K993135 | IMPLANTABLE CLIP FOR GENERAL SURGERY | FZP | 1999-12-01 |
| 151776 | 1506564538 | K993135 | IMPLANTABLE CLIP FOR GENERAL SURGERY | FZP | 1999-12-01 |
| 5178 | 1506564538 | K993135 | IMPLANTABLE CLIP FOR GENERAL SURGERY | FZP | 1999-12-01 |
| 5178 | 1542190659 | K991219 | C-FLEX URETERAL STENTS | FAD | 1999-06-21 |
| 151776 | 1542190659 | K991219 | C-FLEX URETERAL STENTS | FAD | 1999-06-21 |
| 178748 | 1542190659 | K991219 | C-FLEX URETERAL STENTS | FAD | 1999-06-21 |
| 5178 | 1527678944 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 151776 | 1527678944 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 178748 | 1527678944 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 31886 | 1198153220 | K980305 | AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE | KNT | 1998-04-16 |
| 31886 | 1084948761 | K980145 | AMT DECOMPRESSION TUBES | KGC | 1998-04-10 |
| 31886 | 2002721481 | K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | KNT | 1997-12-19 |
| 5178 | 1248100587 | K973465 | LATIS GRAFT CLEANING CATHETER | DXE | 1998-02-19 |
| 151776 | 1248100587 | K973465 | LATIS GRAFT CLEANING CATHETER | DXE | 1998-02-19 |
| 31886 | 2028272970 | K971758 | CAUTERIZATION SMOKE EVACUATOR | GEI | 1997-07-21 |
| 31886 | 1199081278 | K971757 | LOW PROFILE FEEDING SET ACCESSORY | KNT | 1997-11-07 |
| 31886 | 1052959077 | K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | KNT | 1998-08-17 |
| 151776 | 1529196059 | K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | DXE | 1997-03-28 |
| 5178 | 1529196059 | K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | DXE | 1997-03-28 |
| 5178 | 1377322711 | K963359 | INSUFFLATION NEEDLE | HET | 1996-09-24 |
| 151776 | 1377322711 | K963359 | INSUFFLATION NEEDLE | HET | 1996-09-24 |
| 178748 | 1377322711 | K963359 | INSUFFLATION NEEDLE | HET | 1996-09-24 |
| 178748 | 1833204696 | K962668 | AMR-ACV CLAMPS | DXC | 1996-11-04 |
| 151776 | 1833204696 | K962668 | AMR-ACV CLAMPS | DXC | 1996-11-04 |
| 5178 | 1833204696 | K962668 | AMR-ACV CLAMPS | DXC | 1996-11-04 |
| 31886 | 1999433006 | K960232 | ENDOSCOPIC ACCESS DEVICE | GCJ | 1996-03-21 |
| 5178 | 1059252139 | K950586 | AVD INTIMAX THROMBECTOMY CATHETER | DXE | 1995-05-15 |
| 151776 | 1059252139 | K950586 | AVD INTIMAX THROMBECTOMY CATHETER | DXE | 1995-05-15 |
| 5178 | 1638455619 | K950492 | ATRAUMAX SURGICAL CLAMP | DXC | 1995-05-08 |
| 151776 | 1638455619 | K950492 | ATRAUMAX SURGICAL CLAMP | DXC | 1995-05-08 |
| 178748 | 1638455619 | K950492 | ATRAUMAX SURGICAL CLAMP | DXC | 1995-05-08 |
| 31886 | 1777870586 | K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | KNT | 1995-10-12 |
| 178748 | 1977121392 | K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | LYK | 1995-02-10 |
| 151776 | 1977121392 | K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | LYK | 1995-02-10 |
| 5178 | 1977121392 | K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | LYK | 1995-02-10 |
| 5178 | 1077592249 | K944135 | UROLOGICAL GUIDWIRE | KNY | 1994-09-21 |
| 151776 | 1077592249 | K944135 | UROLOGICAL GUIDWIRE | KNY | 1994-09-21 |
| 178748 | 1077592249 | K944135 | UROLOGICAL GUIDWIRE | KNY | 1994-09-21 |
| 178748 | 1505856789 | K943489 | DISPOSABLE SURGICAL TROCAR | GCJ | 1994-08-09 |
| 151776 | 1505856789 | K943489 | DISPOSABLE SURGICAL TROCAR | GCJ | 1994-08-09 |
| 5178 | 1505856789 | K943489 | DISPOSABLE SURGICAL TROCAR | GCJ | 1994-08-09 |
| 5178 | 1140768919 | K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | EYB | 1994-04-18 |
| 151776 | 1140768919 | K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | EYB | 1994-04-18 |
| 178748 | 1140768919 | K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | EYB | 1994-04-18 |
| 178748 | 1140621589 | K932995 | SURGICAL TROCAR AND CANNULA | GCJ | 1993-09-23 |
| 151776 | 1140621589 | K932995 | SURGICAL TROCAR AND CANNULA | GCJ | 1993-09-23 |
| 5178 | 1140621589 | K932995 | SURGICAL TROCAR AND CANNULA | GCJ | 1993-09-23 |
| 151776 | 1144427289 | K931895 | ENDOSCOPE ACCESSORY | GCJ | 1993-09-07 |
| 178748 | 1144427289 | K931895 | ENDOSCOPE ACCESSORY | GCJ | 1993-09-07 |
| 5178 | 1144427289 | K931895 | ENDOSCOPE ACCESSORY | GCJ | 1993-09-07 |
| 178748 | 1650560157 | K923636 | TROCAR W/ BLUNT TIP OBTURATOR | HET | 1993-11-05 |
| 151776 | 1650560157 | K923636 | TROCAR W/ BLUNT TIP OBTURATOR | HET | 1993-11-05 |
| 5178 | 1650560157 | K923636 | TROCAR W/ BLUNT TIP OBTURATOR | HET | 1993-11-05 |
| 178748 | 1372061309 | K921838 | ACUCISE URETERAL CUTTING CATHETER | EYB | 1993-02-26 |
| 151776 | 1372061309 | K921838 | ACUCISE URETERAL CUTTING CATHETER | EYB | 1993-02-26 |
| 5178 | 1372061309 | K921838 | ACUCISE URETERAL CUTTING CATHETER | EYB | 1993-02-26 |
| 5178 | 1406317621 | K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | 1992-03-18 |
| 151776 | 1406317621 | K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | 1992-03-18 |
| 178748 | 1406317621 | K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | 1992-03-18 |
| 151776 | 1956717426 | K911181 | INTIMAX(TM) IRRIGATION CATHETER | GCA | 1991-04-18 |
| 5178 | 1956717426 | K911181 | INTIMAX(TM) IRRIGATION CATHETER | GCA | 1991-04-18 |
| 151776 | 1353839459 | K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | FGE | 1991-03-28 |
| 5178 | 1353839459 | K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | FGE | 1991-03-28 |
| 151776 | 1843139089 | K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | 1991-04-26 |
| 5178 | 1843139089 | K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | 1991-04-26 |
| 151776 | 1055890976 | K910006 | AVD INTIMAX (TM) BILIARY CATHETER | FGE | 1991-02-13 |
| 5178 | 1055890976 | K910006 | AVD INTIMAX (TM) BILIARY CATHETER | FGE | 1991-02-13 |
| 178748 | 1430148382 | K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | 1991-03-21 |
| 151776 | 1430148382 | K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | 1991-03-21 |
| 5178 | 1430148382 | K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | 1991-03-21 |
| 5178 | 1104296000 | K903848 | DIAGNOSTIC INTRASCULAR CATHETER | DQO | 1991-03-25 |
| 151776 | 1104296000 | K903848 | DIAGNOSTIC INTRASCULAR CATHETER | DQO | 1991-03-25 |
| 178748 | 1104296000 | K903848 | DIAGNOSTIC INTRASCULAR CATHETER | DQO | 1991-03-25 |
| 151776 | 1549883341 | K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | DQY | 1991-02-15 |
| 5178 | 1549883341 | K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | DQY | 1991-02-15 |
| 178748 | 1395379831 | K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | DXC | 1990-07-06 |
| 151776 | 1395379831 | K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | DXC | 1990-07-06 |
| 5178 | 1395379831 | K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | DXC | 1990-07-06 |
| 151776 | 1019212085 | K901627 | ARTERIAL EMBOLECTOMY CATHETER | DXE | 1990-10-19 |
| 5178 | 1019212085 | K901627 | ARTERIAL EMBOLECTOMY CATHETER | DXE | 1990-10-19 |
| 178748 | 1974658392 | K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | DXC | 1990-06-12 |
| 151776 | 1974658392 | K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | DXC | 1990-06-12 |
| 5178 | 1974658392 | K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | DXC | 1990-06-12 |
| 5178 | 2027106207 | K895691 | VASCULAR CLAMP | DXC | 1989-12-13 |
| 151776 | 2027106207 | K895691 | VASCULAR CLAMP | DXC | 1989-12-13 |
| 178748 | 2027106207 | K895691 | VASCULAR CLAMP | DXC | 1989-12-13 |
| 5178 | 1625189987 | K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | DXC | 1989-06-07 |
| 151776 | 1625189987 | K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | DXC | 1989-06-07 |
| 178748 | 1625189987 | K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | DXC | 1989-06-07 |
| 5178 | 1402810198 | K883909 | SURGICAL SPRING CLIPS | DSS | 1988-12-27 |
| 151776 | 1402810198 | K883909 | SURGICAL SPRING CLIPS | DSS | 1988-12-27 |
| 178748 | 1402810198 | K883909 | SURGICAL SPRING CLIPS | DSS | 1988-12-27 |
| 151776 | 1109723200 | K883790 | SURGICAL CLAMP INSERTS | DXC | 1988-12-27 |
| 178748 | 1109723200 | K883790 | SURGICAL CLAMP INSERTS | DXC | 1988-12-27 |
| 5178 | 1109723200 | K883790 | SURGICAL CLAMP INSERTS | DXC | 1988-12-27 |
| 5178 | 1291448936 | K880987 | INJECTOR HANDLE WITH SYRINGE | DXT | 1988-05-13 |
| 151776 | 1291448936 | K880987 | INJECTOR HANDLE WITH SYRINGE | DXT | 1988-05-13 |
| 178748 | 1291448936 | K880987 | INJECTOR HANDLE WITH SYRINGE | DXT | 1988-05-13 |
| 151776 | 1299351422 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | 2026-02-23 |
| 5178 | 1299351422 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | 2026-02-23 |
| 31886 | 1555408189 | K252438 | Explant Express | QVS | 2026-02-03 |
| 5178 | 1137517190 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | 2025-10-02 |
| 151776 | 1137517190 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | 2025-10-02 |
| 31886 | 1431771008 | K241111 | AMT Suture Passer | GCJ | 2024-07-05 |
| 31886 | 1129833489 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | KOB | 2024-11-01 |
| 151776 | 1753392493 | K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | 2023-11-01 |
| 5178 | 1753392493 | K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | 2023-11-01 |
| 151776 | 1405388215 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | 2022-10-14 |
| 5178 | 1405388215 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | 2022-10-14 |
| 151776 | 1115965782 | K220969 | GelPOINT V-Path Vaginal Access System | MOK | 2022-09-16 |
| 5178 | 1115965782 | K220969 | GelPOINT V-Path Vaginal Access System | MOK | 2022-09-16 |
| 5178 | 2031022648 | K211043 | Alexis Contained Extraction System | GCJ | 2022-03-31 |
| 151776 | 2031022648 | K211043 | Alexis Contained Extraction System | GCJ | 2022-03-31 |
| 178748 | 2031022648 | K211043 | Alexis Contained Extraction System | GCJ | 2022-03-31 |
| 5178 | 1165961951 | K202818 | Voyant Fine Fusion Device (EB230) | GEI | 2021-12-16 |
| 151776 | 1165961951 | K202818 | Voyant Fine Fusion Device (EB230) | GEI | 2021-12-16 |
| 31886 | 1217449433 | K202539 | Nutriglide(TM) Nasal Feeding Tube | KNT | 2020-10-29 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GCJ | 55 | 2024-07-05 |
| GEI | 43 | 2022-10-14 |
| DXC | 24 | 2001-01-08 |
| KNT | 18 | 2020-10-29 |
| KGW | 17 | 2026-02-23 |
| HET | 12 | 2006-08-24 |
| DXE | 10 | 1998-02-19 |
| FER | 9 | 2017-07-20 |
| FAD | 9 | 2006-03-29 |
| HEW | 8 | 2025-10-02 |
| FGE | 7 | 1991-03-28 |
| FED | 6 | 2003-05-23 |
| FZP | 6 | 2001-05-14 |
| EYB | 6 | 1994-04-18 |
| KGC | 3 | 2020-03-12 |
| GDW | 3 | 2019-11-22 |
| BTA | 3 | 2012-10-02 |
| FHF | 3 | 2001-02-01 |
| FMF | 3 | 1998-06-11 |
| LYK | 3 | 1995-02-10 |
| KNY | 3 | 1994-09-21 |
| ODC | 3 | 1992-03-18 |
| DQO | 3 | 1991-03-25 |
| DSS | 3 | 1988-12-27 |
| DXT | 3 | 1988-05-13 |
| MOK | 2 | 2022-09-16 |
| CCK | 2 | 2014-11-24 |
| GCA | 2 | 1991-04-18 |
| DQY | 2 | 1991-02-15 |
| QVS | 1 | 2026-02-03 |
| KOB | 1 | 2024-11-01 |
| PIO | 1 | 2015-06-09 |
| PIF | 1 | 2015-01-29 |
Applied Medical Resources Corporation
Applied Medical Resources Corporation
Applied Medical Resources Corporation
Applied Medical
Applied Medical Resources
Applied Medical Technology, Inc.
Applied Medical Resources Corp.
Applied Medical Resources Corp.
Applied Medical Technology, Inc.
Applied Medical Resources Corp.
Applied Medical Resources Corporation
Applied Medical Resources Corp.
Applied Medical Technology, Inc.
Applied Medical Technology, Inc.
Applied Medical Resources Corp.
Applied Medical Resources Corp.
Applied Medical Resources Corp.
Applied Medical Technology, Inc.
Applied Medical Resources Corporation
Applied Medical Resources Corporation
APPLIED MEDICAL TECHNOLOGY INC.
Applied Medical Resources Corporation
Applied Medical Resources Corp.
APPLIED MEDICAL TECHNOLOGY, INC.
Applied Medical Resources
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL TECHNOLOGY, INC.
Applied Medical Technology, Inc.
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL RESOURCES CORP.
APPLIED MEDICAL RESOURCES CORP.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.