10 results · 25ms · Sources: EU EUDAMED, US FDA

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T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·September 27, 2024

SYNTHES CERVIFIX/ AXON

FDA 510(k)
FDA Class 2 ·Orthopedic

SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

ATRICURE BIPOLAR SYSTEM

FDA Adverse Event
Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

COULTER® LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·April 23, 2013

ZEPHYR XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·September 9, 2014

GENESIS IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 13, 2011

NUVASIVE HELIX ACP SYSTEM

FDA Adverse Event
Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 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