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Rochester Medical Corp.

Last updated May 23, 2026

Information

Country: US
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DUNS Number: —

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
FemSoft® Insert Female Urethral Insert	72201	FDA UDI	Class III	Unknown
FemSoft® Insert Female Urethral Insert	72203	FDA UDI	Class III	Unknown
Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female	51514S	FDA UDI	Class II	Active
FemSoft® Insert Female Urethral Insert	71201	FDA UDI	Class III	Unknown
Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male	53514GS	FDA UDI	Class II	Active
Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male	53512GS	FDA UDI	Class II	Active
FemSoft® Insert Female Urethral Insert	70200	FDA UDI	Class III	Unknown
Magic3™ Hydrophilic Intermittent Catheter, Male	53614GS	FDA UDI	Class II	Active
FemSoft® Insert Female Urethral Insert	71202	FDA UDI	Class III	Unknown
Magic3™ Hydrophilic Intermittent Catheter, Female	51614S	FDA UDI	Class II	Active
FemSoft® Insert Female Urethral Insert	71203	FDA UDI	Class III	Unknown
FemSoft® Insert Female Urethral Insert	72202	FDA UDI	Class III	Unknown
Magic3™ Hydrophilic Intermittent Catheter, Male	53616GS	FDA UDI	Class II	Active
Female Length All Silicone Urological Catheter	K941692	FDA 510(k)	Class II	Active
All Silicone Foley Catheter	K896053	FDA 510(k)	Class II	Active
All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter	K981612	FDA 510(k)	Class II	Active
Personal Catheter	K970704	FDA 510(k)	Class II	Active
Hydrosil; Magic; Personal Catheter	K122785	FDA 510(k)	Class II	Active
Hydrophilic Silicone Foley Catheter And Personal Catheter (hydrophilic And Non-Hydrophilic)	K000723	FDA 510(k)	Class II	Active
Silicone Antibacterial Foley Catheter	K971627	FDA 510(k)	Class II	Active
Comfort Sleeved All Silicone Foley Catheter	K905042	FDA 510(k)	Class II	Active
Male External Catheter	K923136	FDA 510(k)	Class I	Active
Rochester Medical Corporation Silicone Male External Catheter	K952082	FDA 510(k)	Class I	Active
Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit	K033477	FDA 510(k)	Class II	Active
All Silicone Intermittent Catheter	K943851	FDA 510(k)	Class II	Active
Release Nf Antibacterial Foley Catheter, Antibacterial Personal Catheter	K001143	FDA 510(k)	Class II	Active
Femsoft Urethral Insert	P990002	FDA PMA	Class III	Active

Related Companies

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FDA Recalls (22)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 27, 2010	Z-1910-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1908-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1907-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1909-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1913-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1906-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1911-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Apr 27, 2010	Z-1912-2010	—	terminated	Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Jan 14, 2009	Z-1077-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1079-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1075-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1084-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1082-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1085-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1078-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1087-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1076-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1086-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1081-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1080-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1074-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
Jan 14, 2009	Z-1083-2009	—	terminated	Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.