71 results
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7ms
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Sources: EU EUDAMED, US FDA
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 30, 2016
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
FDA Enforcement
Class II
·Terminated·Southmedic, Inc.·April 11, 2018
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
FDA Enforcement
Class II
·Terminated·Canon Medical System, USA, INC.·September 12, 2018
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
FDA Enforcement
Class II
·Terminated·Phadia Ab·April 11, 2018
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
ROYALSILK 2XLARGE, Gown. Item Code 9578
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020