22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESEP OLIGON OXIMETRY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00600931·
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450029978·
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0600030·Tray Insert, Level 3
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600130·Tray Insert 3, Cosmolock Deformity
BD BBL¿ VITAMIN K1 - HEMIN SOLUTION
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·August 6, 2024
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
FDA 510(k)
FDA Class 2
·Anesthesiology
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL¿ VITAMIN K1 - HEMIN SOLUTION
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
S5 CONTROL PANEL
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABS.·Product code FTL·April 11, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2008
2124215-2011-05924
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code LWS·April 15, 2011
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016