22 results
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19ms
·
Sources: EU EUDAMED, US FDA
ZIEHM VISION RFD
FDA 510(k)
FDA Class 2
·Radiology
Infinity Internal Hex System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950008063·UCLA Ø3.5mm 4.5MM WIDE HEXED W/SCREW FOR IHEX
TRI-CAM Dental Implant System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950008001·UCLA Ø3.5mm 4.5MM WIDE HEXED W/SCREW FOR INFINI...
A PLUS INTERNATIONAL, INC
FDA registration
A PLUS INTERNATIONAL, INC·5 products·🇺🇸 United States
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 10, 2011
BX SONIC STENT DELIVERY SYSTEM (OUS RX)
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code MAF·July 28, 2008
BD INSYTE ¿ IV CATHETER WINGED
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 26, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016