17 results
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20ms
·
Sources: EU EUDAMED, US FDA
ARIOL HER-2/NEU IHC
FDA 510(k)
FDA Class 2
·Hematology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950014194·LUER LOCK TIP PLASTIC 14G NS AUTOCLAVABLE 270 D...
Full Blue X-ray Film WB
FDA UDI
CARESTREAM HEALTH, INC.·40889971031712·100SH 35X43-14X17 BLUE X-RAY WB
MACROPORE IB RESORBABLE PLUG
FDA 510(k)
FDA Class 2
·Orthopedic
POWDERED PATIENT EXAMINATION GLOVES, LATEX
FDA 510(k)
FDA Class 1
·General Hospital
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 26, 2025
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 26, 2025
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 26, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·April 2, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 21, 2011
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 15, 2008
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018