12 results
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66ms
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Sources: EU EUDAMED, US FDA
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 10KPES SIZE: 10Fr Product No: AAM 8010KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 10KPES Product No: AAM 8010KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 8KPES Product No: AAM 8008KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 16KPES SIZE:16Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 16KPES Product No: AAM 8016KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
FDA Recall
Terminated
·American Medical Systems, Inc.·Product code EZY·March 1, 2013
AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
FDA Recall
Terminated
·American Medical Systems, Inc.·Product code EZY·March 1, 2013
IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
FDA Recall
Terminated
·Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel·Product code MSQ·June 7, 2011
Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair
FDA Recall
Terminated
·American Medical Systems, Inc.·Product code FTL·May 9, 2011
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Duomed Belgium NV
Importer
🇧🇪 Belgium·62 Manufacturers