Unit, Suction Operatory
Dental · 21 CFR 872.6640
Recent MDR events
5 adverse event reports on file
- DEVILBISS 7305 SUCTION UNITNov 1, 2016MalfunctionDevilbissMW5065772
- ALLEGIANCEDec 15, 2004OtherBusse Hospital Disposables, Inc.2433012-2004-00001
- *May 20, 2004Injury*1018233-2004-00027
- ALLEGIANCE POOLE SUCTION INSTRUMENTOct 18, 2002OtherBusse Hospital Disposbles2433012-2002-00001
- EVACUATORDec 30, 1992InjuryZimmer Patient Care Division33141-1992-00002
Event type breakdown
Recalls
3 recall events for this product code
- Busse Hospital DisposablesTerminatedJul 20, 2004
Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. R
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
Z-0843-04 · View FDA record ↗ - Busse Hospital DisposablesTerminatedJul 20, 2004
Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx O
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
Z-0844-04 · View FDA record ↗ - Busse Hospital DisposablesTerminatedJul 20, 2004
Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free.
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
Z-0845-04 · View FDA record ↗
Registered firms
75 firms currently registered for this product code
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Shanghai Greeloy Industry Co., Ltd
Shanghai, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Micrylium Laboratories Inc.
TORONTO Ontario, CA
Shenzhen Denco Medical Co., Ltd.
Shenzhen Guangdong, CN
Osung Mnd Co., Ltd.
Gimpo-si Gyeonggi, KR
Guangzhou Ajax Medical Equipment Co Ltd
Guangzhou Guangdong, CN
Guilin Refine Medical Instrument Co., Ltd.
Guilin Guangxi, CN
Ads Dental System Inc.
Ontario, CA, US
Dentalree.com
Las Vegas, NV, US
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Epdent Co., Ltd.
Gimpo-city Gyeonggi, KR
Dewimed Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Beaverstate Dental, Inc.
NEWBERG, OR, US
Jiangsu Yongfa Medical Equipment Technology Co., Ltd
Zhangjiagang City Jiangsu, CN
Wuxi Lyusmile Imp And Exp Co.,ltd
WUXI Jiangsu, CN
Shanghai No. 2 Medical College Duhang Medical Equipment Factory
Shanghai, CN
Aesculap, Inc.
CENTER VALLEY, PA, US
Narang Medical, Ltd.
New Delhi, IN
Dental Studio
Anyang-si Gyeonggi, KR
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Foshan Gladent Medical Instrument Co.,ltd.
Foshan Guangdong, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Geotec, Inc.
Warwick, RI, US
Jiangsu Rooe Medical Technology Co., Ltd.
Zhangjiagang City Jiangsu, CN
510(k) clearances
3 clearances for this product code