13 results
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26ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959000667·PerformaTrak Mask, Small, Reusable Pack, Intern...
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION TPSA CALIBRATOR, MODEL #RC459
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EQUINOXE REVERSE 42MM GLENOSPHERE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 29, 2022
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 27, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·July 11, 2014
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024