8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TDX DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FACT PLUS ONE-STEP PREGNANCY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·June 1, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 21, 2012
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Malfunction
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·August 27, 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
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019