40 results
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59ms
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Sources: EU EUDAMED, US FDA
E K INDUSTRIES, INC.
FDA registration
E K INDUSTRIES, INC.·32 products·🇺🇸 United States
FORMALIN CONTAINER
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·July 28, 2023
FORMALIN
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·August 31, 2023
FIXATIVE, FORMALIN
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IGG·December 7, 2021
FORMALIN CONTAINER
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·June 30, 2023
PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.)
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·August 9, 2022
PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ)
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·March 3, 2023
FORMALIN JAR
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·February 9, 2023
FORMALIN CONTAINER 60ML
FDA Adverse Event
Malfunction
·E K INDUSTRIES, INC.·Product code IFP·November 20, 2023
DEXCOM G6 CGM (CONTINUOUS GLUCOSE MONITOR) SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·September 8, 2023
DEXCOM G6 CGM (CONTINUOUS GLUCOSE MONITOR) SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·September 8, 2023
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
COATED VICRYL
FDA Adverse Event
Malfunction
·ETHICON, LLC·Product code GAM·September 1, 2023
FOLEY CATHETER, 400 SERIES 10 FR
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code EYC·July 7, 2025
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code QAN·April 4, 2025
Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A 60535-A 60600-A 60602-4A 60630-A 60635-4A 60640-4A 60705-4A 60709-A 60800-6A 60800-A 60801-A 60820-A 60903-A 60910-A 60921-A 60925-A 60930-A 61020-A 61023-A 61026-4A 61028-3A 61030-3A 61044-6A 61052-4A 61100-A 61204-A 61206-4A 61206-6A 61303-A 61401-A 61404-A 65500-4A 70410-4A 70500-3A 70500-A 70550-A 70602-3A 70604-6A 70630-3A 70640-4A 70808-6A 70910-A In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.
FDA Recall
Terminated
·Express Diagnostics Int'l., Inc.·Product code DIC·November 1, 2010
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