22 results
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9ms
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Sources: EU EUDAMED, US FDA
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
FDA Enforcement
Class I
·Ongoing·Busse Hospital Disposables, Inc.·January 10, 2024
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
FDA Enforcement
Class I
·Ongoing·Busse Hospital Disposables, Inc.·January 10, 2024
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
FDA Enforcement
Class I
·Ongoing·Busse Hospital Disposables, Inc.·January 10, 2024
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
FDA Enforcement
Class I
·Ongoing·AMTEC SALES Inc·September 29, 2021
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·February 19, 2025
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·June 12, 2024
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·August 31, 2022
Getinge Flow-e Anesthesia System, Part No. 6887900
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·February 1, 2023
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·February 1, 2023
Getinge Flow-c Anesthesia System, Part No. 6887700
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·February 1, 2023
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·January 19, 2022
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
FDA Enforcement
Class I
·Terminated·Getinge Usa Sales Inc·June 29, 2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
FDA Enforcement
Class I
·Terminated·Getinge Usa Sales Inc·June 29, 2022
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 18, 2012
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·May 8, 2013
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·June 17, 2015
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 2, 2016
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 5, 2018