10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PROGASTRO SSCS ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
SBH
FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...
ArgenPMMA Multi98x25-B4
FDA UDI
ARGEN CORPORATION, THE·D818123274·Crown And Bridge, Temporary, Resin
FOOTPRINT ULTRA PK SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
FDA 510(k)
FDA Class 2
·Radiology
CLEARLINK BURETROL SOLUTION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 13, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 26, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
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