8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SAMPLE IDENTIFICATION STATION MODEL 38010
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMS GRAM-NEGATIVE IDENT. CARD
FDA 510(k)
FDA Class 1
·Microbiology
MODEL 483-02 PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 13, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 27, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024