BEUDAMED
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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 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) 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) 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) 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

    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

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJW·July 16, 2024

    30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

    FDA Recall
    Open, Classified ·B. Braun Medical, Inc.·Product code DXT·September 26, 2023

    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·June 12, 2024

    HYDRATOME RX 49-30MM/260CM Material Number: M00583010

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026

    Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026

    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026

    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

    Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·February 2, 2023

    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026

    Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code KNS·December 18, 2025

    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    DREAMTOME 49-20MM/260CM Material Number: M00584000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021