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