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

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NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

Acapella One

FDA UDI
Choice Spine, LP·00840996151351·ACAPELLA,TRIAL,CX,NS,14X16X11

CARDIOCAM MODEL 9CSY0799

FDA 510(k)
FDA Class 2 ·Radiology

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

COVER, BURR HOLE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code GXR·July 1, 2016

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 12, 2018

ARCHITECT HAVAB-G

FDA Adverse Event
Malfunction ·ABBOTT GERMANY·Product code LOL·April 22, 2013

UNO

FDA Adverse Event
Injury ·LIKO AB·Product code FSA·April 13, 2011

ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 9, 2008

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·October 7, 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

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