289 results · 9ms · Sources: EU EUDAMED, US FDA

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Hemospray Endoscopic Hemostat

FDA Recall
Terminated ·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019

Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

FDA Recall
Terminated ·Battelle Memorial Institute·Product code QKY·August 13, 2020

Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.

FDA Recall
Terminated ·Sterilmed Inc·Product code NKU·August 8, 2008

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

PORT-A-CATH II POWER P.A.C. Low Profile" system.

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code LJT·June 11, 2020

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

Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

FDA Enforcement
Class II ·Terminated·Bausch & Lomb, Inc.·January 18, 2017

Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

FDA Enforcement
Class II ·Terminated·Bausch & Lomb Inc- Greenville Solutions Plant·May 14, 2014

Bivona Aire-Cuf Endotracheal Tube

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021

Bivona Uncuffed Wire Endotracheal Tubes,

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021

Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged; HoMedics, Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494 The individually packaged toothbrushes are packaged 49 per case labeled as Decent Trading Adult Battery Operated Toothbrush Model #HD-30, Quantity: 49 pcs, Colour: Blue/Green, Made in China C/No 884

FDA Recall
Terminated ·Deals Nothing Over A Dollar·Product code JEQ·February 16, 2005

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

FDA Enforcement
Class II ·Terminated·Central Purchasing LLC DBA Harbor Freight Tools·April 16, 2014

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

FDA Enforcement
Class II ·Terminated·Sunstar Americas, Inc.·June 16, 2021

CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

Rifton E-Pacer, SKU K660, powered lift device

FDA Recall
Terminated ·Community Products, LLC·Product code FSA·March 21, 2019

Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

FDA Recall
Terminated ·Central Purchasing LLC DBA Harbor Freight Tools·Product code ITJ·March 27, 2014