Company ยท US
Rochester Medical Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2013. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KOD | Catheter, Urological | 16 |
| OCK | Transurethral Occlusion Insert, Urinary Incontinence-Control, Female | 8 |
| EZL | Catheter, Retention Type, Balloon | 3 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 3 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 |
| GBM | Catheter, Urethral | 2 |
| EZD | Catheter, Straight | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2013 | K122785 | HYDROSIL; MAGIC; PERSONAL CATHETER Rochester Medical Corp. | EZD |
| Jun 10, 2004 | K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT Rochester Medical Corp. | MJC |
| Jul 7, 2000 | K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER Rochester Medical Corp. | MJC |
| May 19, 2000 | K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) Rochester Medical Corp. | KOD |
| Jul 8, 1998 | K981612 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER Rochester Medical Corp. | EZL |
| Jan 13, 1998 | K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER Rochester Medical Corp. | MJC |
| Mar 13, 1997 | K970704 | PERSONAL CATHETER Rochester Medical Corp. | GBM |
| Jul 18, 1995 | K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER Rochester Medical Corp. | EXJ |
| Mar 6, 1995 | K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER Rochester Medical Corp. | EZL |
| Jan 31, 1995 | K943851 | ALL SILICONE INTERMITTENT CATHETER Rochester Medical Corp. | GBM |
| Dec 3, 1992 | K923136 | MALE EXTERNAL CATHETER Rochester Medical Corp. | EXJ |
| Jan 18, 1991 | K905042 | COMFORT SLEEVED ALL SILICONE FOLEY CATHETER Rochester Medical Corp. | EZL |
| Feb 12, 1990 | K896053 | ALL SILICONE FOLEY CATHETER Rochester Medical Corp. | KOD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2010 | Rochester Medical Corp 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 FSSTDSU Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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 Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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. Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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. Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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 U Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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 U Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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-p Terminated |
OCK | None listed |
| Jun 25, 2010 | Rochester Medical Corp 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 Terminated |
OCK | None listed |
| Mar 16, 2009 | Rochester Medical Corp 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 Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp 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, Rocheste Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp 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, Ste Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp 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 BN1 Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616
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. Hydrophilic 14 French Male Length REF 53614
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. Hydrophilic 12 French Male Length REF 53612
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. 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 |