18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546246·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546239·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546192·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546185·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546208·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546215·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033546222·
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH
FDA Adverse Event
Death
·BECTON DICKINSON·Product code FOZ·April 1, 2016
DATA MANAGEMENT HARDWARE
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 10, 2011
MEVATRON KDS-2
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS·Product code IYE·March 12, 2008
UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FOZ·March 4, 2016
TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·September 10, 2021
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