16 results · 23ms · Sources: EU EUDAMED, US FDA

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APTUS Clavicle System

FDA 510(k)
FDA Class 2 ·Orthopedic

PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

AURA

FDA 510(k)
FDA Class 2 ·Dental

ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

HELICAL BLADE INSERTER

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

SOLYX SIS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011

HELICAL BLADE INSERTER

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016

HELICAL BLADE EXTRACTOR

FDA Adverse Event
Malfunction ·Product code LXH·February 4, 2016

HELICAL BLADE INSERTER

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016

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

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

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