11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTOCHIN DIAGNOSTIC DISC
FDA 510(k)
FDA Class 1
·Microbiology
ACUMED
FDA UDI
Acumed LLC·10806378097836·Depth Gauge
MODEL 4815 ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
PACSMATE MMD-3213M MONITOR
FDA 510(k)
FDA Class 2
·Radiology
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·September 23, 2019
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 9, 2014
HUDSON/SHERIDAN ENDOTRACHEAL TUBE, HVT, 7.0
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·October 18, 2012
MODULAR CORE WITH 1 ISE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026