Rochester Medical Corp.
Stewartville, MN, US
Rochester Medical Corp. appears in FDA device records in Stewartville, MN. FDA records list 13 510(k) clearances between and , 3 PMA records and no registered establishments. As of , FDA records show 22 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Rochester Medical Corp. between 1990 and 2013. The busiest year on record is 1995, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 3 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 2 |
| 2004 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122785 | HYDROSIL; MAGIC; PERSONAL CATHETER | EZD | Substantially Equivalent | |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | MJC | Substantially Equivalent | |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | MJC | Substantially Equivalent | |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | KOD | Substantially Equivalent | |
| K981612 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | MJC | Substantially Equivalent | |
| K970704 | PERSONAL CATHETER | GBM | Substantially Equivalent | |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | EXJ | Substantially Equivalent | |
| K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER | EZL | Substantially Equivalent | |
| K943851 | ALL SILICONE INTERMITTENT CATHETER | GBM | Substantially Equivalent | |
| K923136 | MALE EXTERNAL CATHETER | EXJ | Substantially Equivalent | |
| K905042 | COMFORT SLEEVED ALL SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K896053 | ALL SILICONE FOLEY CATHETER | KOD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1913-2010 | FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The FSSTDSUP product is a Clinician Supply Pack that is provided directly to clinics. The Clinician Supply Pack is a package containing 2 multi-pack boxes of product. The corresponding retail box label for this product (FSSTDSUP) is the REF 70200. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long. | 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 | Terminated | ||
| Z-1912-2010 | FemSoft Insert, Female Urethral Insert, Size 3 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72203 or 72203DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1911-2010 | FemSoft Insert, Female Urethral Insert, Size 2 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72202 or 72202DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1910-2010 | FemSoft Insert, Female Urethral Insert, Size 1 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72201 or 72201DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1909-2010 | FemSoft Insert, Female Urethral Insert, Size 3 Standard, 3.5 cm Length, Sterile (R), Rx Only, REF 71203 or 71203DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1908-2010 | FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length, Sterile (R), Rx Only, REF 71202 or 71202DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1907-2010 | FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long. | 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 | Terminated | ||
| Z-1906-2010 | FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. | 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 | Terminated | ||
| Z-1087-2009 | HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1086-2009 | HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1085-2009 | HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1084-2009 | HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1083-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1082-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1081-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1080-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1079-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1078-2009 | 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 including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1077-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1076-2009 | Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1075-2009 | Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated | ||
| Z-1074-2009 | Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement. | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain