9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C & B METABOND (MODIFICATION)
FDA 510(k)
FDA Class 2
·Dental
COULTER 5C CELL CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Opticage(R) Expandable Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
PD 1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code LDD·February 4, 1997
OPERATING CYSTOSCOPE-URETHROSCOPE
FDA Adverse Event
Death
·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 9, 2014
PROVISC IBC
FDA Adverse Event
Malfunction
·ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.·Product code LZP·January 25, 2013
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·January 13, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024