21 results · 25ms · Sources: EU EUDAMED, US FDA

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Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

VersaLoop Anchor System

FDA 510(k)
FDA Class 2 ·Orthopedic

Crown - A2

FDA UDI
Sprintray, Inc.·00850039704819·SprintRay Crown is a light-curable polymerizabl...

Navajo Tribal Utility Authority - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112632·BARRON CORNEAL PUNCH 8.0MM

EASY TOUCH

FDA 510(k)
FDA Class 2 ·General Hospital

CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 27, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 13, 2022

BD ULTRA-FINE¿ SHORT PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 24, 2022

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; 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

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025