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Sources: EU EUDAMED, US FDA
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StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
FDA Recall
Open, Classified
·Nalu Medical, Inc.·Product code GZF·June 3, 2024
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·October 31, 2024
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·April 22, 2022
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·September 18, 2024
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FET·August 21, 2024
16 G / 5F Dual Lumen L-Cath catheter only.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005