19 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRAcel RF Microneedle System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517567635·CoRoent Ant TLIF PEEK, 8x13x28mm 4°
LAMINOPLASY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PIEZOSURGERY MEDICAL
FDA 510(k)
FDA Class 2
·Orthopedic
OPTICROSS HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 21, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
OPTICROSS? HD
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025