83 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
FDA Enforcement
Class II
·Terminated·Afassco Inc·August 15, 2012
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 19, 2014
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Enforcement
Class II
·Ongoing·KOB GmbH·March 18, 2026
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
FDA Enforcement
Class II
·Ongoing·Stryker Medical Division of Stryker Corporation·March 22, 2023
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 20, 2020
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·December 21, 2016
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·April 25, 2018
The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·December 26, 2012
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 3, 2012
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·June 22, 2016
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
Ferno PROFlexx¿ Model 28Z Chair Cot
FDA Enforcement
Class II
·Terminated·Ferno-Washington Inc·April 26, 2017
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·November 10, 2021
6376 M-1 Cot Fastener, catalog no. 6376000000
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 9, 2018
6381 M-1 Cot Fastener, catalog no. 6381000000
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 9, 2018
Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019