10 results · 18ms · Sources: EU EUDAMED, 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