9 results · 19ms · Sources: EU EUDAMED, 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