9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ULTRABLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123137·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 150mm
URICASE (U.V.) URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAIRE COMPANION 5 OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·January 17, 2013
CXD II
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·December 13, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 9, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024