9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
FDA 510(k)
FDA Class 2
·Radiology
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
FDA 510(k)
FDA Class 2
·Anesthesiology
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
FDA 510(k)
FDA Class 2
·Microbiology
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code FAS·July 13, 2015
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·November 30, 2010
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 2, 2014
WHITESTAR PHACO HANDPIECE
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·July 31, 2024