20 results · 22ms · Sources: EU EUDAMED, US FDA

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DISPOSAL ECG ELECTRODES, MODEL EASYRODE

FDA 510(k)
FDA Class 2 ·Cardiovascular

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY

FDA 510(k)
FDA Class 2 ·Neurology

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·January 9, 2019

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·September 26, 2018

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·December 10, 2019

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 30, 2019

56MM AND R3 ACETABULAR SHELL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

SONOMA CRX

FDA Adverse Event
Injury ·SONOMA ORTHOPEDIC PRODUCTS INC.·Product code HSB·April 30, 2013

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·September 16, 2014

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 3, 2011

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·December 12, 2018

UNKNOWN

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FCG·December 21, 2021

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·October 20, 2023

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·October 3, 2019

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·October 3, 2019

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·December 19, 2019

ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·June 5, 2020

Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·February 26, 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