8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUGMENT AND SCREW, PSA TYPE
FDA 510(k)
FDA Class 2
·Orthopedic
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 21, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code BRZ·June 13, 2011
RSVR MMT-332A 10PK PRDGM 3CC 14L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS, MED-REL·Product code FMF·August 15, 2008
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024