9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
FDA 510(k)
FDA Class 2
·Orthopedic
ORIGEN BLADDER HOLDER
FDA 510(k)
FDA Class 2
·Cardiovascular
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
3.5MM TI CORTEX SCREW 18MM
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HRS·August 27, 2014
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
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