ClearanceBrief
Panels › Gastroenterology, Urology › Product code EYB · Class 2

Catheter, Ureteral, Gastro-Urology

Regulation 876.5130

0510(k)s in 12 months (28 all time)
2recalls in 12 months (4 all time)
4recalls that name a 510(k)
Get daily alerts for EYBSample briefCSV

Top companies in EYB

Company510(k)sRecalls
Applied Medical Resources40
Cook Incorporated30
Medline Industries, Inc.12
Boston Scientific Corp20
C.R. Bard, Inc.20
Coloplast Corp.20
Cook Urological, Inc.20
Hobbs Medical, Inc.11
Acmi Corporation10
Amsino International, Inc.10
DateFirm and productCodeLinked 510(k)
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
Open, Classified		 EYBK092250
Jun 17, 2026Medline Industries, LP
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15
Open, Classified		 EYBK092250
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
Open, Classified		 EYBK914358
Sep 16, 2008Gyrus ACMI Corporation
Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement,
Terminated		 EYBK043581

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.