11 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
FDA Enforcement
Class II
·Terminated·Medicel Ag·August 28, 2013
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·November 13, 2013
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·April 18, 2018
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·April 18, 2018
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical AG·August 22, 2018
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical AG·August 22, 2018
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
FDA Enforcement
Class II
·Terminated·Swissray Medical AG·January 16, 2019
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
FDA Enforcement
Class II
·Terminated·Thommen Medical AG·May 29, 2019
Hamilton-C6
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·November 30, 2022
HAMILTON-C6, REF: 160021
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·May 3, 2023
impression coping, repositionable, short, screw-retained, PF 4.0
FDA Enforcement
Class II
·Ongoing·Thommen Medical AG·March 27, 2024