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TraumaGuard Intra-abdominal Pressure-Sensing System

SENTINEL MEDICAL TECHNOLOGIES · Model TraumaGuard Philips Cable · UDI-DI 00860003478738

PHLEZLEXY Prescription
10
510(k) clearances
57
Adverse events
3
Recalls
8
Facilities

Description

The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.

Recalls

DateFirmReason
2025-04-03WANDERCRAFT SASPotential for exoskeleton to lose lateral balance and cause patient to fall.
2020-02-28Argo Medical Technologies LtdReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caug
2017-08-14Argo Medical Technologies LtdFirm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.