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

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LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

FDA 510(k)
FDA Class 2 ·Hematology

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·14026704920645·

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704266498·FRAZIER TUBE 12 FRENCH

devemed

FDA UDI
devemed GmbH·04061644032792·Suction cannula Ø 4mm | 17.0cm with slot agains...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A24283080·24mm H x 28mm W x 30mm L x 8 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A242830120·24mm H x 28mm W x 30mm L x 12 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A242830150·24mm H x 28mm W x 30mm L x 15 degrees ALIF

Reicodent

FDA UDI
devemed GmbH·04061644061501·Suction cannula Ø 4mm | 17.0cm with slot agains...

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2023

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2023

POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

Ophthalmed Bending Laser Probes

FDA 510(k)
FDA Class 2 ·Ophthalmic

CURRENT RF DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011

530G INSULIN PUMP MMT-751NAS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 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