17 results · 38ms · Sources: EU EUDAMED, US FDA

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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 C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

FDA Enforcement
Class I ·Ongoing·Hamilton Medical AG·August 27, 2025

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

FDA Enforcement
Class I ·Ongoing·Hamilton Medical AG·August 6, 2025

Ventilator HAMILTON-C6, PN: 160021

FDA Enforcement
Class I ·Ongoing·Hamilton Medical AG·June 26, 2024

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 Intensive Care Ventilator, REF: 160021

FDA Enforcement
Class I ·Ongoing·Hamilton Medical AG·August 31, 2022

HAMILTON-H900 Humidifier, Models: 950001, 950004

FDA Enforcement
Class III ·Completed·Hamilton Medical AG·July 20, 2022

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

HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

FDA Enforcement
Class I ·Terminated·Hamilton Medical AG·July 17, 2019

impression coping, repositionable, short, screw-retained, PF 4.0

FDA Enforcement
Class II ·Ongoing·Thommen Medical AG·March 27, 2024