Medical Device Manufacturer · US , Rancho Santa , CA

Applied Medical Resources Corp.

45 submissions · 45 cleared · Since 2001
45
Total
45
Cleared
0
Denied

Applied Medical Resources Corp. — FDA 510(k) Submissions

Applied Medical Resources Corp. has submitted 45 FDA 510(k) premarket notifications since 2001, of which 45 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Electrosurgical, Cutting & Coagulation & Accessories, Ring (wound Protector), Drape Retention, Internal, Anoscope And Accessories, Stent, Ureteral . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
Voyant? Open Fusion Device (EB240/Open Fusion)
K252740 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2025 68d
Kii Structural Balloon Access System
K252442 · GCJ Laparoscope, General &... · General & Plastic Surgery
Oct 2025 88d
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152 · HEW Culdoscope (and Accessories) · Obstetrics & Gynecology
Oct 2025 367d
Voyant Open Fusion Device
K201212 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jun 2020 31d
Voyant Maryland Fusion Device
K200598 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2020 30d
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
K193292 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2019 23d
Transvaginal Access Platform
K191294 · HEW Culdoscope (and Accessories) · Obstetrics & Gynecology
Sep 2019 115d
Voyant Maryland Fusion Device
K182653 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2018 50d
Voyant Electrosurgical Generator
K182244 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2018 52d
Dissecting Balloon System
K182024 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2018 31d
GelPOINT Path Transanal Access Platform
K171701 · FER Anoscope And Accessories · Gastroenterology & Urology
Jul 2017 42d
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
K132300 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2014 184d
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393 · FER Anoscope And Accessories · Gastroenterology & Urology
Jan 2014 58d
ALEXIS O WOUND PROTECTOR/RETRACTOR
K113268 · KGW Ring (wound Protector),... · General & Plastic Surgery
Feb 2013 462d
GELPOINT PATH
K110792 · FER Anoscope And Accessories · Gastroenterology & Urology
May 2011 63d
LAPAROSCOPIC DISSECTOR
K103282 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2010 11d
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
K100120 · KGW Ring (wound Protector),... · General & Plastic Surgery
Apr 2010 77d
ALEXIS LAPAROSCOPIC SYSTEM
K093296 · KGW Ring (wound Protector),... · General & Plastic Surgery
Nov 2009 15d
GELPORT SINGLE INCISION ACCESS SYSTEM
K090275 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2009 14d
FIXATION TROCARS
K083638 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2008 14d
KII TROCAR SYSTEM
K072674 · GCJ Laparoscope, General &... · General & Plastic Surgery
Oct 2007 14d
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · DYB Introducer, Catheter · Cardiovascular
Sep 2007 278d
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Aug 2006 24d
GELPORT BLUNT TIP TROCAR SYSTEM
K060629 · GCJ Laparoscope, General &... · General & Plastic Surgery
Apr 2006 29d
PEDIATRIC URETERAL STENT
K060673 · FAD Stent, Ureteral · Gastroenterology & Urology
Mar 2006 15d
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