7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ULTRAVIT
FDA 510(k)
FDA Class 2
·Ophthalmic
IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
LO-COMP RESERVOIR-RE-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 27, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 15, 2012
LAMITRODE 4 CHANNEL LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022