38 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO ALPHA DX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 26, 2025
AVISTA MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 14, 2021
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 17, 2024
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 26, 2012
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 6, 2012
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 6, 2012
S5 SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010
S5 SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010
S5 SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010
S5 SENSOR MODULE FOR BUBBLE DETECTOR
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTW·October 21, 2016
HARMONIC ACE
FDA Adverse Event
Malfunction
·STERILMED·Product code LFL·April 17, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 23, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
LCD TOUCHSCREEN, RP150, S5
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 14, 2012