BEUDAMED
    233 results · 13ms · Sources: EU EUDAMED, US FDA

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    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·January 16, 2024

    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LJE·October 17, 2025

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    ESG PK CUTTING FORCEPS, 5MM, 33CM

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·December 15, 2023

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code MND·February 23, 2023

    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

    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

    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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-0730; 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

    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 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 (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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

    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; 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

    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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-V411M-3030 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-V411M-3025 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 (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; 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