Dilator, Rectal
Gastroenterology, Urology · 21 CFR 876.5450
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
47 firms currently registered for this product code
Sabokay Industries
Sialkot Punjab, PK
Aus Systems Pty Ltd.
ALLENBY GARDENS South Australia, AU
Kapp Surgical Instrument, Inc.
Bedford Heights, OH, US
Oui Lab Inc.
City of Industry, CA, US
Plus Ev Holdings Inc
North Kansas City, MO, US
Phoenix Instruments, Inc.
Lisle, IL, US
Design Standards Corp.
CHARLESTOWN, NH, US
Acme Commercial Ways Ltd.
Sialkot Punjab, PK
Teleflex Medical Llc
Morrisville, NC, US
Comfort Surgical Instruments
Sialkot Punjab, PK
Teleflex Llc (nadc)
Olive Branch, MS, US
Isomedix Operations Inc
El Paso, TX, US
Surgicrafts
Sialkot Punjab, PK
Cotronic Technology Limited
SHENZHEN, GUANG DONG PROVINCE Guangdong, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Surjex
SIALKOT Punjab, PK
Shenzhen Linglu Hongtu Technology Co., Ltd
Shenzhen Guangdong, CN
Mian Shahid Corp.
MUZAFFAR PUR, SIALKOT Punjab, PK
Sapi Med S.p.a
ALESSANDRIA, IT
Crown Surgical Corp.
Sialkot Punjab, PK
Coopersurgical, Inc.
Trumbull, CT, US
Pilotis Tech Llc
Brookhaven, GA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
510(k) clearances
5 clearances for this product code
- Mk Conquest Intl., Inc.Jun 6, 1997
K964634 · ANOKRYO
- Telemed Systems, Inc.Jun 21, 1990
K901426 · COLONIC BALLOON DILATOR
- Inamed Development Co.Jan 18, 1990
K894618 · INAMED RHEMO-D (TM) DILATOR
- Primrose Medical, Inc.Sep 29, 1989
K884713 · COLONIC BALLOON DIALATORS
- Cleveland Medical Supply & ServicesMay 27, 1983
K830354 · COLORECTAL DILATOR