14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ARI STANDARD ANESTHESIA RECORD
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994806826·TRAY 1854213 4.75 X10 CROSSLINK 1
Legacy™3 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102137·Ø4.2 x 13 Platform 3.5mmD
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746058394·CHAIN PLASTIC 15' SHORT CLEAR
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746033278·CHAIN PLASTIC 15' SHORT CLEAR
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127108·
STIMTECH SD PATIENT 6089 #78-8050
FDA 510(k)
FDA Class 2
·Neurology
ISOCONTROL SERUM CK-MB
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LEGACY 3 IMPLANT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code DZE·October 3, 2019
MK SYRINGE 3-P, LL 10CC
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FMF·May 29, 2014
MINIARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 29, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·September 30, 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
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