14 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810321081·ZODIAC GLOVE PF LATEX
ZODIAC
FDA UDI
HENRY SCHEIN, INC.·00304040056943·ZODIAC Small
REGENESIS BIOMEDICAL, INC.
FDA registration
REGENESIS BIOMEDICAL, INC.·2 products·🇺🇸 United States
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0361080·Compressor, Fixed Tip
K032008
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LJT·May 31, 2007
MEDPOR COATED TEAR DRAIN
FDA 510(k)
FDA Unclassified
·Unknown
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 31, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·March 6, 2013
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 28, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·April 18, 2008
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018