BEUDAMED
    34 results · 12ms · Sources: EU EUDAMED, US FDA

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    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7501 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray With Plastic Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad. Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7500 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray Without Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7502 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 French Red Rubber Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 14 French Red Rubber Catheter Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7504 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 30 mL Prefilled Syringe Including BZK Swabsticks nurse assist incorporated A6005, R1 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 30 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7503 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 10 mL Prefilled Syringe Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 10 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 13, 2021

    Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8155 Urethral Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT7015 Catheter Insertion Tray 10 cc Pre-Filled Syringe with BZK Swabs contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 10 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT7035 Catheter Insertion Tray 30 cc Pre-Filled Syringe with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT8145 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays. Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·August 13, 2014

    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

    FDA Recall
    Terminated ·Teleflex Medical·Product code FCM·July 10, 2014

    Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations

    FDA Recall
    Terminated ·Apogee Medical, Inc·Product code OHR·March 24, 2011

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FAM·April 6, 2016

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code ODG·April 6, 2016

    Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code GCJ·April 6, 2016