3,662 results
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50ms
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Sources: EU EUDAMED, US FDA
Rose Medical
FDA registration
Rose Medical·7 products·🇺🇸 United States
Rose Medical
FDA registration
Rose Medical·1 product·🇺🇸 United States
DORMA 500 AUTO
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·December 6, 2023
Masques à usage médical à liens Type IIR Roses - Boîte de 50
Device
EU MDR
·
Eu Md Class 1
·VBI Sarl·On the market
Masques à usage médical à élastiques Type IIR Roses - Boîte de 50
Device
EU MDR
·
Eu Md Class 1
·VBI Sarl·On the market
Masques à usage médical à élastiques Type II Roses - Boîte de 50
Device
EU MDR
·
Eu Md Class 1
·VBI Sarl·On the market
Masques à usage médical à élastiques Type II Roses - Sachet de 10
Device
EU MDR
·
Eu Md Class 1
·VBI Sarl·On the market
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 27, 2013
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·October 23, 2013
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 13, 2023
ROLL-A-BOUT SCOOTER
FDA Adverse Event
Injury
·UNKNOWN·Product code ITJ·August 12, 2023
COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Death
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 4, 2007
Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·May 17, 2012
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 17, 2024
SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code KTI·March 20, 2024
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·March 20, 2024
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·April 1, 2026
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 6, 2013
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code HBT·June 19, 2018
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·December 30, 2025