12 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Confirm Rx Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Synthes GmbH·10886982145130·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042123755·CLEAR DOUBLE ENDED OCCLUSAL RETRACTOR- SHORT
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)
NICHOLS ADVANTAGE THYROGLOB
FDA 510(k)
FDA Class 2
·Immunology
ACUBEAM, SUPER NOVA, DIO
FDA 510(k)
FDA Class 2
·Physical Medicine
TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·October 26, 2006
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·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