15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ACA URINARY PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222320·Cervical Rasp 6x12x12
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GMK NARROW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014
OPENING JACK BACK ARM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code LXH·May 23, 2012
GANDRAS
FDA Adverse Event
Malfunction
·VASCULAR SOLUTIONS, INC.·Product code DQO·September 1, 2010
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022
GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016
GMK PS TIBIAL INSERT SIZE 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015
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