10 results · 21ms · Sources: EU EUDAMED, US FDA

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QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C

FDA 510(k)
FDA Class 2 ·Cardiovascular

NA

FDA UDI
FORTEC FIBERS, INC.·00816901020067·

BD SAFETYGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 22, 2023

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 23, 2021

SALUTE

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

SOMATOM P30 CT SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 6, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

TFX ISIS SUBCLOTTIC SEC. ET TUBE, 7.5MM

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BTR·April 6, 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