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

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AEQUALIS SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDSTAR 150

FDA 510(k)
FDA Class 2 ·Physical Medicine

PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMJ·February 19, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

MINI TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·April 19, 2011

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 29, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015