Panels › Gastroenterology, Urology › Product code KOD · Class 2
Catheter, Urological
Regulation 876.5130
1510(k)s in 12 months (238 all time)
1recalls in 12 months (108 all time)
80recalls that name a 510(k)
Top companies in KOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Nurse Assist, Inc | 0 | 34 |
| C.R. Bard, Inc. | 10 | 12 |
| COVIDIEN LLC | 0 | 17 |
| Teleflex Medical | 0 | 17 |
| Rochester Medical Corp. | 2 | 14 |
| Convatec Limited | 3 | 7 |
| Abco Dealers, Inc. | 9 | 0 |
| Van-Tec, Inc. | 8 | 0 |
| Boston Scientific Corp | 5 | 2 |
| The Kendal Co. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder mana Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manag Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder management i Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manage Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manageme Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managem Terminated |
KOD | K000723 |
| Feb 27, 2004 | C.R. Bard, Inc., Urological Division BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Terminated |
KOD | None listed |
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