14 results
·
32ms
·
Sources: EU EUDAMED, US FDA
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MENS FREEDOM MICRO
FDA 510(k)
FDA Class 2
·Neurology
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 8, 2006
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·February 8, 2014
MYOCARDIAL LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
MYOCARDIAL LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
BRASSELER DRILL BIT
FDA Adverse Event
Injury
·BRASSELER·Product code HWE·February 28, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DRY·February 3, 2011
HUDSON MASK, MEDIUM CONC, ELONG, ADULT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BYG·July 23, 2014
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017