7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ALLEGIANCE PORTA-WARM MATTRESS
FDA 510(k)
FDA Class 1
·Physical Medicine
COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
FDA 510(k)
FDA Class 2
·General Hospital
BITTAR ZIRCONIA BLOCKS
FDA 510(k)
FDA Class 2
·Dental
NOVOSYN VIOLET 2 (5) 90CM HR40S (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·June 16, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 28, 2013
NDEHP 3CLV YSTE MACR
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·December 20, 2010
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