10 results · 17ms · Sources: EU EUDAMED, US FDA

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COMPLEMENT C3 NEPHELOMETRIC ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

LANDANGER

FDA UDI
LANDANGER·03661219199656·

NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012

CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 16, 2010

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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