Medical Device Manufacturer · US , Norwood , MA

Uromed Corp.

10 submissions · 10 cleared · Since 1997
10
Total
10
Cleared
0
Denied

Uromed Corp. — FDA 510(k) Submissions

Uromed Corp. has submitted 10 FDA 510(k) premarket notifications since 1997, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Probe And Director, Gastro-urology, Clamp, Penile, Endoscopic Tissue Approximation Device, External Urethral Occluder, Urinary Incontinence-control, Female . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN Stimulator, Nerve · Ear, Nose, Throat
Apr 2001 87d
MODIFICATION TO CAVERMAP SURGICAL AID
K010098 · FGM Probe And Director,... · Gastroenterology & Urology
Feb 2001 21d
CAVERMAP SURGICAL AID
K000507 · ETN Stimulator, Nerve · Ear, Nose, Throat
Apr 2000 66d
CAVERMAP SURGICAL AID
K993436 · FGM Probe And Director,... · Gastroenterology & Urology
Feb 2000 122d
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · KXK Source, Brachytherapy,... · Radiology
May 1999 323d
UROMED SLING KIT
K980717 · KNA Instrument, Manual,... · Obstetrics & Gynecology
May 1998 87d
UROMED PATCH
K974600 · MNG External Urethral... · Gastroenterology & Urology
Mar 1998 112d
UROMED NEEDLE GRASPER
K974137 · OCW Endoscopic Tissue... · Gastroenterology & Urology
Jan 1998 88d
URO MED NERVE STIMULATOR
K970971 · ETN Stimulator, Nerve · Ear, Nose, Throat
Oct 1997 224d
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
K971992 · FHA Clamp, Penile · Gastroenterology & Urology
Aug 1997 64d
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