22 results
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39ms
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Sources: EU EUDAMED, US FDA
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
FDA Recall
Terminated
·Nico Corp.·Product code GEI·April 30, 2021
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.
FDA Recall
Terminated
·Nico Corp.·Product code GEI·April 30, 2021
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
FDA Recall
Terminated
·Nico Corp.·Product code GEY·July 29, 2015
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
FDA Recall
Terminated
·Nico Corp.·Product code GZT·June 19, 2018
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Recall
Terminated
·Nico Corp.·Product code GZT·July 17, 2012
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Recall
Terminated
·Nico Corp.·Product code GZT·July 17, 2012
Myriad handpiece Tissue morcellator
FDA Recall
Terminated
·Nico Corp.·Product code GEY·February 24, 2014
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
FDA Enforcement
Class II
·Terminated·Nico Corp.·August 22, 2018
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Enforcement
Class II
·Terminated·Nico Corp.·August 22, 2012
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Enforcement
Class II
·Terminated·Nico Corp.·August 22, 2012
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class II
·Terminated·Nico Corp.·September 23, 2015
Myriad handpiece Tissue morcellator
FDA Enforcement
Class II
·Terminated·Nico Corp.·June 29, 2016
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.
FDA Enforcement
Class II
·Terminated·Nico Corp.·June 16, 2021
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
FDA Enforcement
Class II
·Terminated·Nico Corp.·June 16, 2021
Aspen Surgical Puerto Rico Corp.
FDA registration
Aspen Surgical Puerto Rico Corp.·3 products·🇺🇸 United States
BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PUERTO RICO CORP.·Product code GES·December 29, 2021
BARD-PARKER
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PUERTO RICO CORP.·Product code GES·November 1, 2016
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
FDA Enforcement
Class II
·Terminated·Aspen Surgical Puerto Rico Corp.·September 14, 2016
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
FDA Recall
Terminated
·Aspen Surgical Puerto Rico Corp. Rd 183 Km 20.3 Las·Product code GES·June 27, 2016
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices