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

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Light Cure Dental Adhesive

FDA 510(k)
FDA Class 2 ·Dental

DJO SURGICAL

FDA UDI
Encore Medical, L.P.·00190446885948·SPECIAL, RSP IM HUMERAL OSTEOTOMY GUIDE, SUPERI...

HHM

FDA UDI
Oticon A/S·05707131355195·G300 SC, MINIRITE 312 2.4G C079 HHM

QUART ARTERIAL FILTER, MODEL HBF 140

FDA 510(k)
FDA Class 2 ·Cardiovascular

VISUCAM

FDA 510(k)
FDA Class 1 ·Radiology

CONTOUR® PLUS BLUE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

GE OEC 6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

M2A MAGNUM MODULAR HEAD

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWA·August 5, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 2, 2013

CONTOUR® CARE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025

CONTOUR® CARE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

CONTOUR® NEXT

FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025

HLM TUBING SET

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

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