9 results · 35ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SERALYZER HEMOGLOBIN CALIBRATORS

FDA 510(k)
FDA Class 2 ·Hematology

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28220461·Betaflex wires Titanium Straight-Arch-F. max. ....

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

WRIST PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023

ILLINOIS (TJ) NEEDLE, ASPIRATION, 18G

FDA Adverse Event
Injury ·CAREFUSION·Product code KNW·April 5, 2010

HARMONIC ACE CURVED SHEARS INSERT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014

ADVIA CENTAUR XP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·November 7, 2012

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