50 results · 6ms · Sources: EU EUDAMED, US FDA

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Amplatz Stiff Wire Guide

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 21, 2018

Amplatz Ultra Stiff Wire Guide

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 21, 2018

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·January 15, 2014

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

FDA Enforcement
Class II ·Terminated·CryoLife, Inc.·October 24, 2018

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·September 4, 2013

Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

FDA Enforcement
Class II ·Terminated·Penner Mfg Inc·April 1, 2015

Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

FDA Enforcement
Class II ·Terminated·Winco Mfg., LLC·March 5, 2014