36 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STELLAR 404T
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00600581·
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450146279·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0600080·Try insert, InTess C Level 1
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0600080·Tray Insert, Lumbar Rods
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0600080·Tray Insert, Level I
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631502·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631496·
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014
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
PROFEMUR(R) HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010