16 results
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20ms
·
Sources: EU EUDAMED, US FDA
Tunnel Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
SPROTTE® NRFit
FDA UDI
Pajunk GmbH Medizintechnologie·14048223030261·SPROTTE® NRFit
22G x ...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111333460·DRESS FCP DEL SERR 5 1/2
SPROTTE® NRFit
FDA UDI
Pajunk GmbH Medizintechnologie·04048223127261·SPROTTE® NRFit 22G x 4" (103mm) with IntroDucer...
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223116517·Needle
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223065266·Distal Tip: SPROTTE®
Proximal End: ISO 80369-6
Bone Cement Genta, Bone Cement HV, Bone Cement LV
FDA 510(k)
FDA Class 2
·Orthopedic
OCTEIA 25-HYDROXY VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
*
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAB·October 21, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 8, 2013
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018