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

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INSTRUMENTS NONSTERILE & STERILE

FDA 510(k)
FDA Class 1 ·Neurology

neria™ detach

FDA UDI
Unomedical A/S·05705244000896·Single use infusion set for subcutaneous infusi...

contact detach

FDA UDI
Unomedical A/S·05705244005853·Single use infusion set for subcutaneous infusi...

contact detach

FDA UDI
Unomedical A/S·05705244004351·Single use infusion set for subcutaneous infusi...

contact detach

FDA UDI
Unomedical A/S·05705244005839·Single use infusion set for subcutaneous infusi...

SURE-SNAP

FDA UDI
Gc Orthodontics America Inc.·E53580272600001·SURE-SNAP 2. MOLAR UPR LFT SZ 26

CARDIOHELP SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TCOYF FERTILITY SOFTWARE VERSION 1.0

FDA 510(k)
FDA Unclassified ·Unknown

CARDIOHELP SYSTEM

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

HLM TUBING SET W/BIOLINE COATING

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2012

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 17, 2010

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