59 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·March 31, 2021
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
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
Custom Tubing Packs Custom tubing pack for oxygenators
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·April 20, 2016
Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
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 51502 Ochsner ECC Adult Pack Material: 709000385
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
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
Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
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 46200 3/16" x 1/4" Neonate Pack Material: 701065620
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
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
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