11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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