Data / Medical devices / United States / Applied Medical Distribution Center
Applied Medical Distribution Center: FDA-registered device maker in Irvine, CA, United States, 73 510(k) clearances
Applied Medical Distribution Center is registered with the FDA (registration 3009051888) in Irvine, CA, United States. It lists 30 device types. The FDA files 73 510(k) clearances under its listings, the newest dated April 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009051888
- Address
- 9401 Toledo Way, Irvine, CA, United States, 92618
- Owner or operator
- APPLIED MEDICAL RESOURCES (2027111)
- Roles
- Manufacturer
- First device listed
- April 18, 2000
- Registered through
- 2026
- Brand names listed
- Alexis® Lighted Wound Protector-Retractor, GelPOINT Path Transanal Access Platform, GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | KGW | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| February 23, 2026 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| October 2, 2025 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| November 1, 2023 | K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| October 14, 2022 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| September 16, 2022 | K220969 | GelPOINT V-Path Vaginal Access System | MOK | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| March 31, 2022 | K211043 | Alexis Contained Extraction System | GCJ | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| December 16, 2021 | K202818 | Voyant Fine Fusion Device (EB230) | GEI | Substantially Equivalent | Applied Medical | accessdata.fda.gov |
| June 5, 2020 | K201212 | Voyant Open Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| April 8, 2020 | K200598 | Voyant Maryland Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| September 6, 2019 | K191294 | Transvaginal Access Platform | HEW | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| November 14, 2018 | K182653 | Voyant Maryland Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 11, 2018 | K182244 | Voyant Electrosurgical Generator | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| August 30, 2018 | K182024 | Dissecting Balloon System | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| April 13, 2018 | K180699 | Voyant Open Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| February 13, 2018 | K172624 | Voyant 5mm Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| August 7, 2017 | K171684 | Epix Electrosurgical Probe with Smoke Evacuation | GEI | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| July 20, 2017 | K171701 | GelPOINT Path Transanal Access Platform | FER | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| July 6, 2016 | K153017 | Voyant Fine Fusion | GEI | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| December 23, 2014 | K142427 | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| August 22, 2014 | K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE | GEI | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| January 24, 2014 | K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 2, 2014 | K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | FER | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| November 16, 2010 | K103282 | LAPAROSCOPIC DISSECTOR | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| April 22, 2010 | K100959 | SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| February 18, 2009 | K090275 | GELPORT SINGLE INCISION ACCESS SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| December 23, 2008 | K083638 | FIXATION TROCARS | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 5, 2007 | K072674 | KII TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 9, 2007 | K062907 | ALEXIS WOUND RETRACTOR | KGW | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| August 24, 2006 | K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | HET | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| April 7, 2006 | K060629 | GELPORT BLUNT TIP TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| March 29, 2006 | K060673 | PEDIATRIC URETERAL STENT | FAD | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| March 13, 2006 | K060534 | INTUITIVE SURGICAL SEAL | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 24, 2006 | K060096 | MODULAR TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 19, 2006 | K060051 | SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 15, 2004 | K040760 | MODIFICATION TO URETERAL STENT | FAD | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| September 14, 2004 | K041795 | MODIFICATION TO OPTICAL SEPARATOR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| March 12, 2004 | K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | HET | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 2, 2003 | K032889 | OPTICAL SEPARATOR | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| May 23, 2003 | K030642 | DEFLECTING URETERAL ACCESS SHEATH | FED | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| February 28, 2002 | K014047 | APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| May 14, 2001 | K011236 | MODIFICATION TO IMPLANTABLE CLIP | FZP | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| February 1, 2001 | K003443 | SUCTION IRRIGATOR | FHF | Substantially Equivalent | Applied Medical | accessdata.fda.gov |
| January 8, 2001 | K002915 | FLEXIBLE OCCLUSION SYSTEM | DXC | Substantially Equivalent | Applied Medical | accessdata.fda.gov |
| December 28, 1999 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | FED | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| June 21, 1999 | K991219 | C-FLEX URETERAL STENTS | FAD | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| February 19, 1998 | K973465 | LATIS GRAFT CLEANING CATHETER | DXE | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| March 28, 1997 | K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| November 4, 1996 | K962668 | AMR-ACV CLAMPS | DXC | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| September 24, 1996 | K963359 | INSUFFLATION NEEDLE | HET | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| May 15, 1995 | K950586 | AVD INTIMAX THROMBECTOMY CATHETER | DXE | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| May 8, 1995 | K950492 | ATRAUMAX SURGICAL CLAMP | DXC | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| September 21, 1994 | K944135 | UROLOGICAL GUIDWIRE | KNY | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| August 9, 1994 | K943489 | DISPOSABLE SURGICAL TROCAR | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| April 18, 1994 | K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | EYB | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| November 5, 1993 | K923636 | TROCAR W/ BLUNT TIP OBTURATOR | HET | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| September 23, 1993 | K932995 | SURGICAL TROCAR AND CANNULA | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| September 7, 1993 | K931895 | ENDOSCOPE ACCESSORY | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| March 18, 1992 | K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | Substantially Equivalent | Applied Urology, Inc. | accessdata.fda.gov |
| April 26, 1991 | K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| April 18, 1991 | K911181 | INTIMAX(TM) IRRIGATION CATHETER | GCA | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| March 28, 1991 | K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | FGE | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| March 21, 1991 | K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| February 15, 1991 | K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | DQY | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| February 13, 1991 | K910006 | AVD INTIMAX (TM) BILIARY CATHETER | FGE | Substantially Equivalent | Applied Vascular | accessdata.fda.gov |
| October 19, 1990 | K901627 | ARTERIAL EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| July 6, 1990 | K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | DXC | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| June 12, 1990 | K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | DXC | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| December 13, 1989 | K895691 | VASCULAR CLAMP | DXC | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| June 7, 1989 | K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | DXC | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| December 27, 1988 | K883909 | SURGICAL SPRING CLIPS | DSS | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| December 27, 1988 | K883790 | SURGICAL CLAMP INSERTS | DXC | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| May 13, 1988 | K880987 | INJECTOR HANDLE WITH SYRINGE | DXT | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
Compare with other makers
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- All makers of Laparoscope, General & Plastic Surgery
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.