10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Confirm Rx Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Synthes GmbH·10886982145079·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113530·SLIT BLADE 3.0MM ANGLED (BX/5)
JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
FDA 510(k)
FDA Class 1
·Physical Medicine
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·July 2, 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