11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COULTER MULTI-Q-PREP
FDA 510(k)
FDA Class 1
·Hematology
ReLine
FDA UDI
Nuvasive, Inc.·00195377069894·RELINE C Screw, 3.5x30mm FA Part Thread
ZAVATION
FDA UDI
Zavation LLC·00842166191525·Reduction Shaft Screw 3.5x30
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837016890·
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111109·INSTRUMENT CASE DOUBLE ALUMINUM
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code CAW·January 22, 2013
ADAPTA
FDA Adverse Event
Death
·MEDTRONIC S.A. (SMO)·Product code NVZ·December 14, 2010
OPTISENSE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·July 9, 2014