10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROZYME T4 ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MINI HARPOON
FDA UDI
Biomet Sports Medicine, LLC·00880304000674·
AXSOS
FDA UDI
Stryker GmbH·07613154110681·Lid for Base - Instruments
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227989·Royce Ear Knife, downcut bld
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
REJUVENATE STEM EXTRACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 29, 2012
APOLLO 3 PORT
FDA Adverse Event
Malfunction
·APOLLO 3 PORT WOUND CARE MANAGEMENT SYSTEM·Product code INX·November 12, 2010
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