9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
PEEP SYSTEM D
FDA 510(k)
FDA Class 2
·Anesthesiology
APPLIED LABORATORIES, INC.
FDA registration
APPLIED LABORATORIES, INC.·7 products·🇺🇸 United States
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BD FACS SAMPLE PREP ASSISTANT III
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SERFAS ENERGY SUPER 90-S
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·May 24, 2014
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 10, 2010
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018