15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ORTHO CLASSICAL PATHWAY COMPL. TEST
FDA 510(k)
FDA Class 2
·Immunology
Stradis
FDA UDI
STRADIS MEDICAL, LLC·M75268218980·Custom Surgical Kit- Vein pack
Stradis
FDA UDI
STRADIS MEDICAL, LLC·M75268218981·Custom Surgical Kit- Vein pack
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
FDA 510(k)
FDA Class 1
·General Hospital
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAMINAR FLOW PHACO TIP 30D 21G INFSL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·February 16, 2018
LAMINAR FLOW PHACO TIP 30D 21G INFSL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·February 16, 2018
LAMINAR FLOW PHACO TIP 30D 21G INFSL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·February 16, 2018
LAMINAR FLOW PHACO TIP 30D 21G INFSL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·February 16, 2018
LAMINAR FLOW PHACO TIP 30D 21G INFSL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·February 16, 2018
ARMADA 35 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·May 20, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 7, 2012
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 31, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012