7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OBUTMENT HB
FDA 510(k)
FDA Class 2
·Dental
OPTIFLUX 160NRE DIALYZER FINISHED ASSY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·May 8, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 15, 2013
STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV.·Product code FPO·January 12, 2011
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024