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