Data / Medical devices / United States / Applied Medical Resources Corp.
Applied Medical Resources Corp.: FDA-registered device maker in Rsm, CA, United States, 76 510(k) clearances
Applied Medical Resources Corp. is registered with the FDA (registration 2027111) in Rsm, CA, United States. It lists 30 device types. The FDA files 76 510(k) clearances under its listings, the newest dated April 24, 2026. 24 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2027111
- Address
- 22872 Avenida Empresa, Rsm, CA, United States, 92688
- Owner or operator
- APPLIED MEDICAL RESOURCES (2027111)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- April 18, 2000
- Registered through
- 2026
- Brand names listed
- APPLIED MEDICAL RESOURCES CORPORATION, Alexis® Lighted Wound Protector-Retractor, GelPOINT Mini Advanced Access Platform, 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 31, 2025 | K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | GEI | 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 29, 2020 | K191866 | GelPOINT Mini Advanced Access Platform | GCJ | Substantially Equivalent | Applied Medical | accessdata.fda.gov |
| April 8, 2020 | K200598 | Voyant Maryland Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| December 20, 2019 | K193292 | Voyant 5mm Fusion Device, 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2025 | 98191 | Class II | Ongoing | Kii Low Profile, Bladed Dual Pack, Qty. 1 5x55mm REF: CTB23 | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. | accessdata.fda.gov |
| January 30, 2024 | 94034 | Class II | Ongoing | Epix Universal Clip Applier, REF: CA500, STERILEEO | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | accessdata.fda.gov |
| March 17, 2020 | 85436 | Class II | Terminated | Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage. | accessdata.fda.gov |
| January 31, 2020 | 85421 | Class II | Terminated | STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | accessdata.fda.gov |
| October 24, 2019 | 85057 | Class I | Terminated | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | accessdata.fda.gov |
| January 28, 2019 | 82986 | Class II | Terminated | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gyne | The product may not have met sterility requirements. Use of a non-sterile device on a patient may expose the patient to infectious agents. | accessdata.fda.gov |
| December 12, 2018 | 83909 | Class II | Terminated | Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent m | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. | accessdata.fda.gov |
| May 4, 2017 | 77277 | Class II | Terminated | Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. | Due to possibility of insufficient sterilization. | accessdata.fda.gov |
| April 1, 2016 | 73737 | Class II | Terminated | Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits. | Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels. | accessdata.fda.gov |
| December 22, 2015 | 73456 | Class II | Terminated | CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance. | accessdata.fda.gov |
| July 31, 2015 | 71956 | Class II | Terminated | Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that use | Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. | accessdata.fda.gov |
| October 21, 2013 | 66610 | Class II | Terminated | Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a di | Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of cau | accessdata.fda.gov |
| May 1, 2013 | 65217 | Class II | Terminated | Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. | Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanen | accessdata.fda.gov |
| November 5, 2012 | 63842 | Class II | Terminated | Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential s | Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107. | accessdata.fda.gov |
| August 9, 2012 | 63100 | Class II | Terminated | Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. | accessdata.fda.gov |
| June 17, 2011 | 59367 | Not yet classified | Terminated | Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not | The recall was initiated because Applied Medical has confirmed specific lot numbers of the Direct Drive Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing and the jaw locking in the closed position. | accessdata.fda.gov |
| March 7, 2011 | 59416 | Not yet classified | Terminated | Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are avail | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier. | accessdata.fda.gov |
| September 10, 2010 | 57702 | Not yet classified | Terminated | Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | accessdata.fda.gov |
| December 18, 2009 | 59560 | Not yet classified | Terminated | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in a tip brea | accessdata.fda.gov |
| June 4, 2009 | 52774 | Not yet classified | Terminated | Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally in | Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage. | accessdata.fda.gov |
| June 25, 2008 | 49445 | Not yet classified | Terminated | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | accessdata.fda.gov |
| May 20, 2008 | 48688 | Not yet classified | Terminated | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or stri | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | accessdata.fda.gov |
| October 17, 2005 | 33856 | Not yet classified | Terminated | The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Te | The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit. | accessdata.fda.gov |
| September 17, 2004 | 30036 | Not yet classified | Terminated | Applied Blunt Tip Trocar Models C0717 and C0718 | Inadequate trocar tip assembly that might yeild parts to patients. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Clamp, Vascular
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Culdoscope (And Accessories)
- All makers of Stent, Ureteral
- All makers of Catheter, Embolectomy
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.