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

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SPECTRA HAIR REMOVAL LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SPO2 WRAP SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

WINNER CM4 COMBINATION UNIT

FDA 510(k)
FDA Class 2 ·Neurology

INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·November 11, 2025

INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·November 11, 2025

UNSPECIFIED SAFESET TRANSPAC SETS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

TPS HANDPIECE CORD

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 11, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·May 27, 2008

UNKNOWN DEPUY 45 BI-POLAR HEAD 28+0 11/13

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·April 7, 2011

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