10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SET GRI-FILL 3.0
FDA 510(k)
FDA Class 2
·General Hospital
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197038942·Paddle Scissors dissecting blade: 25 mm
180mm,...
TRIPLE LUMEN CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOGENESIS LPS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 4, 2013
PRESSURE INFUSION BAG
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code KZD·August 21, 2014
2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·April 14, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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