12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EK12 V2 Algorithm
FDA 510(k)
FDA Class 2
·Cardiovascular
MAEDA SILVER ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
GYNECOLOGY STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
CAPTURE-R READY SCREEN
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·August 30, 2006
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·January 17, 2013
ACCOLADE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWY·November 4, 2008
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 21, 2011
GRAFTYS DELIVERING GUN
FDA Adverse Event
GRAFTYS·Product code MQV·July 11, 2013
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025