16 results · 19ms · Sources: EU EUDAMED, US FDA

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ANSiStim-PP

FDA 510(k)
FDA Unclassified ·Unknown

ELECSYS PTH TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEPUY UNIVERSAL GRIPTION TF CONES

FDA 510(k)
FDA Class 2 ·Orthopedic

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC·Product code NIQ·June 24, 2005

SMALL BATTERY DRIVE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 14, 2014

HUNTER TENDON ROD

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HXA·June 14, 2013

TELIGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·February 4, 2020

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·January 2, 2020

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·February 4, 2020

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Injury ·COOK INC·Product code KRA·January 2, 2020

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024