11 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Vital™ Navigation System

FDA 510(k)
FDA Class 2 ·Neurology

MOBI-C CERVICAL DISC PROSTHESIS

FDA Adverse Event
Injury ·LDR MEDICAL·Product code MJO·March 17, 2016

SPEEDLYSER INFUSION CATHETER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

MARATHON NO STING LIQUID SKIN PROTECTANT

FDA 510(k)
FDA Class 1 ·General Hospital

POLYHESIVE RETURN ELECTRODE

FDA Adverse Event
Injury ·COVIDIEN LP (VALLEYLAB)·Product code ODR·November 12, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

PINNACLE MTL INS NEUT36IDX58OD

FDA Adverse Event
Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·July 18, 2013

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

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

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025