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Panels › Gastroenterology, Urology › Product code FAQ · Class 1

Bag, Urine Collection, Leg, For External Use, Sterile

Regulation 876.5250

0510(k)s in 12 months (18 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
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Top companies in FAQ

Company510(k)sRecalls
Convatec, A Division of E.R. Squibb & Sons30
MEDLINE INDUSTRIES, LP - Northfield03
C.R. Bard, Inc.20
Coloplast Corp.20
Teleflex Medical02
Baka Manufacturing Co., Inc.10
The Boston & Pacific Co., Inc.10
C.R. Bard, Inc., Urological Division01
Coloplast A/S10
Custom Pack Reliability10
DateFirm and productCodeLinked 510(k)
Sep 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Leg bag, REF URO12573
Open, Classified		 FAQNone listed
Sep 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Leg bag, REF DYND12578
Open, Classified		 FAQNone listed
Sep 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Leg bag, REF DYND12574
Open, Classified		 FAQNone listed
Jun 27, 2011Teleflex Medical
***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Prod
Terminated		 FAQNone listed
Jun 27, 2011Teleflex Medical
RUSCH Urinary Drainage Bag, 2000 ml Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
Terminated		 FAQNone listed
May 22, 2003Medegen Medical Products, LLC
GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
Terminated		 FAQNone listed
Apr 17, 2003C.R. Bard, Inc., Urological Division
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
Terminated		 FAQK780032

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