17 results · 21ms · 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.

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496063131·SOCKS FOR YOU BAMBOO MUSIC, SIZE S, GRIGIO, GRA...

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOSCREW XTRALOK

FDA 510(k)
FDA Class 2 ·Orthopedic

STELLARIS VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·October 21, 2020

KLS MARTIN

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 17, 2020

ELECTRIC DERMATOME HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·April 11, 2013

DELTA SHUNT KIT REGULAR, PL 1.5

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·March 22, 2011

F/G ATLANTIS SR PRO TO THE SECOND POWER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORP.·Product code DQO·June 20, 2008

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

ERBE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·October 23, 2024

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·September 20, 2024

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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018