7 results
·
32ms
·
Sources: EU EUDAMED, US FDA
LA-STAPH IDENTIFICATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
FDA 510(k)
FDA Class 2
·Anesthesiology
GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH SAFETY INTRO
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code LJS·March 6, 2014
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·September 8, 2010
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013