11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
FDA 510(k)
FDA Class 2
·Radiology
CS 7600 Smart Plate
FDA UDI
CARESTREAM HEALTH, INC.·60889971060136·50PC CS7600 SMART PLATE SIZE 1 V2 BULK
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801457·Adson Tissue Forceps - 1x2 Teeth, w/Smooth 2.0 ...
VISUALINE BARBITURATES DIPSTRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRIP ALERT
FDA 510(k)
FDA Class 2
·General Hospital
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 16, 2013
LADARVISION 4000
FDA Adverse Event
Malfunction
·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·June 11, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 15, 2011
AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007