8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
USCOM 1A
FDA 510(k)
FDA Class 2
·Radiology
Arthrex Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code MNB·June 2, 2014
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012
8CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 14, 2015
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015