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