11 results · 33ms · 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.

OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115

FDA 510(k)
FDA Class 2 ·Radiology

Aligned Medical Solutions

FDA UDI
Aligned Medical Solutions·B09800624720·Small Basin Kit

DELTA 32 AND DELTA 32 TACT

FDA 510(k)
FDA Class 2 ·Radiology

A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

STONEBREAKER SINGLE USE PROBE

FDA Adverse Event
Malfunction ·COOK INC·Product code FFK·March 28, 2018

5.0MM FLEXIBLE SHAFT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTO·April 16, 2013

SUPERLINE

FDA Adverse Event
Injury ·DENTIUM USA·Product code DZE·April 6, 2011

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 18, 2008

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

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