9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CBR-T3 UPTAKE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981185183·Precontoured Ti Rod, 4.5 x 500mm
SofCare
FDA UDI
STRYKER CORPORATION·07613327282269·
VariAx 2 System
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 5, 2012
MICROVASIVE GOLD PROBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code KNS·August 3, 2010
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024