14 results · 21ms · Sources: EU EUDAMED, US FDA

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PERMA-SET INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

EMT - Siemens Trauma - Red Bag

FDA UDI
Certified Safety Manufacturing, Inc.·00766588226033·EMT - Siemens Trauma - Red Bag

Legacy

FDA UDI
Gc Orthodontics America Inc.·E53582260300001·LEGACY 1. MOLAR UPR LFT SZ 03

IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ONTEX AND OTHER PROPRIETARY NAMES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2012

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·August 27, 2010

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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