21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00141411·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0144110·Trial, TLIF, 32L OB STR 7Deg, 11mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566220·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566237·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566206·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566251·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566268·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566213·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566275·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033566244·
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331149313·
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
FDA 510(k)
FDA Class 2
·Radiology
JAS CALCIUM (ARSENAZO) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·March 9, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 17, 2014
TITANIUM SCREW LOW PROF 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·May 10, 2013
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