8 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
FDA Recall
Terminated
·Hero Health·Product code NXB·July 2, 2021
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
FDA Enforcement
Class II
·Terminated·Hero Health·September 22, 2021
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
FDA Recall
Terminated
·Stryker Spine·Product code LXH·December 18, 2015
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·March 4, 2021
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·November 3, 2014
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·January 27, 2021
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·July 12, 2022
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·July 24, 2020