16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CelerityTM 10 STEAM Chemical Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131331687·OPN 3, KIT 10 NFM 85 PB C001
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071148188·18F x 2.7cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150808·18F x 2.7cm MiniSPC Low Profile Suprapubic Cath...
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
EKOSONIC KIT 106CM 12CM TZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 17, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 25, 2008
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024