8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BOTTLE, BLOOD CULTURE, BI-PHASIC
FDA 510(k)
FDA Class 1
·Microbiology
MIRAGE CEDARS OPTION
FDA 510(k)
FDA Class 2
·Radiology
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 18, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2007
ROTALINK¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·October 3, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022