8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WALKER HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0
FDA 510(k)
FDA Class 2
·Radiology
COBAS ALPHA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 16, 2010
FENESTRATED BIPOLAR FORCEP
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·July 2, 2014
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 20, 2012
CIRCUIT PED 5FT DUAL-HTD 20/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZE·June 1, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024