12 results · 24ms · Sources: EU EUDAMED, US FDA

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MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS

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

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0380820·T-Handle, Ratcheting, Cannulated, Impact

BABYCARE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDSTAR 100 INTERFERENTIAL STIMLATOR

FDA 510(k)
FDA Class 2 ·Neurology

COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

FDA Adverse Event
Injury ·COOK INC·Product code OQY·May 12, 2025

DIDECO COMPACTFLO EVO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code MCX·May 10, 2011

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

FDA Adverse Event
Malfunction ·COSTA RICA·Product code LTI·July 23, 2008

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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