9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIRGO (R) CMV-IGG ELISA
FDA 510(k)
FDA Class 2
·Microbiology
REFINE LIFT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
FDA 510(k)
FDA Class 2
·Hematology
6.0MM TI PANGEA POLYAXIAL SCREW DUAL CORE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 6, 2012
6.0 MM TI PANGEA POLYAXIAL SCREW DUAL CORE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 6, 2012
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·June 19, 2014
PROXIMATE*ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 26, 2010
ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·HAEMONETICS CORP.·Product code CAC·December 18, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017