10 results · 29ms · Sources: EU EUDAMED, US FDA

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DRAD-3000E, RADREX-I

FDA 510(k)
FDA Class 2 ·Radiology

USA SERIES LAPAROSCOPES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 6, 2025

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2024

BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 26, 2023

1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 4MM

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·April 23, 2013

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·April 29, 2011

RIATA ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

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