13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCULAR ARCHITECTS PERISCOPE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575274604·Replacement set, CoCrMo, UHMWPE, rotating hinge...
BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 20, 2024
Q-LUX PLASMA 100 LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
NEOCARE 20 MICRON BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
UNKNOWN HIP COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·March 26, 2025
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·February 11, 2013
ORTHADAPT BIOIMPLANT
FDA Adverse Event
Injury
·PEGASUS BIOLOGICS, INC.·Product code FTM·February 23, 2011
SURGAIRTOME TWO HANDPIECE
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code DZA·February 20, 2008
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024