13 results
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7ms
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Sources: EU EUDAMED, US FDA
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·July 3, 2024
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·November 25, 2015
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·July 11, 2012
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 21, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
FDA Enforcement
Class II
·Terminated·GETINGE US SALES LLC·May 30, 2018
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
FDA Enforcement
Class II
·Terminated·Maquet Medical Systems USA·June 18, 2014
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
FDA Enforcement
Class II
·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024
SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
FDA Enforcement
Class II
·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·March 8, 2017
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
FDA Enforcement
Class II
·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
FDA Enforcement
Class II
·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
FDA Enforcement
Class II
·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019