9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CK/MB IMMUNO-ISOENZYME CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NANOSTIM INTRODUCER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
HANDLE CEV669B DIA 5MM ANG BIPOLAR
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·May 30, 2014
DIMENSION XPAND PLUS WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MMI·November 20, 2012
OPHTHALAS 532 EYELITE LASE SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code GEX·September 17, 2010
10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·June 24, 2020
12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·July 20, 2017
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