10 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LIGMAJECT

FDA 510(k)
FDA Class 2 ·Dental

ACUMED

FDA UDI
Acumed LLC·10806378098321·Tip-Loc™ Bushing Coupler Handle

POWER 5000 GENERAL PURPOSE COIL

FDA 510(k)
FDA Class 2 ·Radiology

QUANTRA

FDA 510(k)
FDA Class 2 ·Radiology

TRUETRACK

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·October 18, 2012

NITRGLYRN MACTO MICR

FDA Adverse Event
Malfunction ·HOSPIRA LTD.·Product code FPA·August 6, 2010

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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