22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HRH-63-8 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
FRYE & CO
FDA UDI
FGX INTERNATIONAL INC.·00193033483077·
CORDIS SLALOM PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
FDA 510(k)
FDA Class 2
·Microbiology
ARCHITECT B12
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code CDD·November 20, 2013
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2024
ARCHITECT B12
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code CDD·December 10, 2013
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 15, 2017
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code LXT·August 15, 2017
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 15, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 20, 2013
ASR XL TAP SLV ADAP 12/14+5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·March 14, 2008
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 15, 2017
UNKNOWN BIOMET DVR-A SCREWS
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code LXT·August 16, 2017
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 15, 2017
UNKNOWN BIOMET DVR-A PLATE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 15, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 27, 2023
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025