13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
RIGIDLOOP
FDA UDI
Medos International Sàrl·10886705022779·RIGIDLOOP Variable Depth Gauge 15-65mm Plus or ...
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369603·THOMAS RADIOLUCENT LEG SPLINT STRAP MEDIUM
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 26, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·November 6, 2014
INCEPTA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 17, 2013
A/R SCREW DRILL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·January 30, 2024
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 22, 2018
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026