Applied Medical Resources Corp

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 invasive surgeries. Endoscopic instruments for surgery.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·June 4, 2009

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

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, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

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, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·January 28, 2019

Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008

Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

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 uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GEI·July 31, 2015

STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020

Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020

Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·May 4, 2017

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.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020

Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

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; A4E08/(01)00607915113476; A4E09/(01)00607915113483

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DXE·October 24, 2019

Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DXE·October 24, 2019

Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DXE·October 24, 2019

Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

FDA Recall

Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020