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

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SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496063490·SOCKS FOR YOU BAMBOO TYPE, SIZE M, NERO, GRADUA...

CHLORAPREP ONE STEP HI LITE ORANGE

FDA Adverse Event
Malfunction ·CAREFUSION 213, LLC 0113·Product code KXF·July 15, 2021

OPUS ROD FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CEMENTED CALCAR HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESTORE ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

PROFEMUR(R) MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·April 19, 2011

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code MFK·June 20, 2008

MEDTRONIC NAVIGATION

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 11, 2024

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

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

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022