11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARESCAPE R860
FDA 510(k)
FDA Class 2
·Anesthesiology
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
CANNULA TWINPAK DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 2, 2024
CANNULA TWINPAK DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·April 27, 2025
IR VIEWER
FDA 510(k)
FDA Class 1
·General Hospital
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ENSEAL G2 CURVED JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 3, 2013
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 21, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 2, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024