21 results · 22ms · Sources: EU EUDAMED, US FDA

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X-LARGE MULTI-FUNCTION TRAUMA DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690110743·Patella Trial 35mm x 8mm

OMNI Knee

FDA UDI
Omni Life Science, Inc.·00841690101970·All Poly 3 Peg Patella 35 mm x 8 mm

COMPRESSYN STAPLE

FDA 510(k)
FDA Class 2 ·Orthopedic

XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248

FDA 510(k)
FDA Class 2 ·Neurology

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 19, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 5, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·December 30, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 12, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 30, 2025

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·December 20, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 2, 2013

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·January 14, 2026

APEX KNEE

FDA Adverse Event
Injury ·OMNILIFE SCIENCE INC.·Product code JWH·April 5, 2023

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·June 27, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·August 11, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 14, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 3, 2025

STONETOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQR·March 11, 2025