12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYN ELISA MICRO ALBUMIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743694·ACHIMED ACHILLES SUPP SILVER VI
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113119·PS Insert, Size 2 x 16mm
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP
GENOSYL MV-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
C-Stem AMT LE Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·January 17, 2013
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·December 10, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 8, 2014
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·December 30, 2015
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·December 30, 2015
Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge.
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code HEB·November 3, 2011