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    HAMILTON BONADUZ AG

    FDA registration
    HAMILTON BONADUZ AG·4 products·🇨🇭 Switzerland

    STAR COMPL. WITH ACCESS.

    FDA UDI
    Hamilton Bonaduz AG·07630032600010·

    STARLET COMPL. WITH ACCESS.

    FDA UDI
    Hamilton Bonaduz AG·07630032600027·

    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 brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·November 17, 2023

    HAMILTON-C6

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·November 23, 2023

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    INTELLICUFF

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 2, 2023

    HAMILTON-MR1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 8, 2023

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 22, 2023

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    HAMILTON-C3

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 10, 2023

    HAMILTON-C2

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·November 10, 2023

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 9, 2023

    HAMILTON-C2

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 2, 2023

    HAMILTON-C6

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 6, 2023