12 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Enforcement
Class II
·Terminated·DeVilbiss Healthcare LLC·October 9, 2013
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 7, 2004
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Recall
Terminated
·DeVilbiss Healthcare LLC·Product code JCX·March 7, 2013
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008
EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008
Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.
FDA Recall
Terminated
·Lacrimedics Inc·Product code LZU·November 26, 2014
HEMO-10 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
HEMO-7 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
FDA Recall
Terminated
·Oasis Medical Inc·Product code LZU·July 6, 2006
The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.
FDA Recall
Terminated
·Tung Keng Enterprise Co., Ltd.
No.1, Lane 160, Section 2,
Tan-Fu Road
Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005
The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.
FDA Recall
Terminated
·Tung Keng Enterprise Co., Ltd.
No.1, Lane 160, Section 2,
Tan-Fu Road
Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005