12 results · 26ms · Sources: EU EUDAMED, US FDA

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ARTERIAL/VENOUS BLOODLINES

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

XLR

FDA UDI
Nuvasive, Inc.·00887517388247·XLR Trial, 16x38x28 8° Detachable

MATTA - PELVIC

FDA UDI
Stryker GmbH·07613153057789·Tray Insert

A-GRIX RESORBABLE BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SMR FINNED HUMERAL BODY

FDA Adverse Event
Malfunction ·LIMACORPORATE SPA·Product code HSD·July 18, 2019

ACCURUS 400VS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECH CTR·Product code HQC·May 7, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 8, 2013

DIMENSION® CLINICAL CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·November 17, 2010

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 18, 2024

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

The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019