20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
LACTOSORB* SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036054168·
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359530·Knee femur prosthesis trial - LINK SLED Prosthesis
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359547·Knee femur prosthesis trial - LINK SLED Prosthesis
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359554·Knee femur prosthesis trial - LINK SLED Prosthesis
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359523·Knee femur prosthesis trial - LINK SLED Prosthesis
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LCI OPTION FOR INNOCOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
KYPHON BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2011
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
LOCK-CLIP F/RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·June 7, 2013
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 27, 2016
OSTEOCOOL RF ABLATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023