15 results · 18ms · Sources: EU EUDAMED, US FDA

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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