13 results · 20ms · Sources: EU EUDAMED, 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