11 results · 23ms · Sources: EU EUDAMED, US FDA

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ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL

FDA 510(k)
FDA Class 2 ·Dental

Aligned Medical Solutions

FDA UDI
Aligned Medical Solutions·B09800919200·Cardiovascular Drape Pack

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 7, 2025

EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

WAKO AUTOKIT LP(A)/ RA,500/1000,

FDA 510(k)
FDA Class 2 ·Immunology

POWERLINK SYSTEM

FDA Adverse Event
Death ·ENDOLOGIX, INC.·Product code MIH·September 11, 2009

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC. CRMD·Product code NVY·January 13, 2014

SM304 M-SERIES W/ZOOM

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·May 3, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011

COBAS INFINITY CORE SOFTWARE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JQP·October 7, 2020

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