17 results · 20ms · Sources: EU EUDAMED, US FDA

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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