12 results · 20ms · Sources: EU EUDAMED, US FDA

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KII TROCAR SYSTEM

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

BIRD AVEA VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

RANDOX MICROALBUMIN

FDA 510(k)
FDA Class 2 ·Immunology

LINEAR 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 4, 2022

VIASYS

FDA Adverse Event
Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

LOCKING TITANIUM ADAPTER

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 23, 2013

LUMEX

FDA Adverse Event
Injury ·DANYANG MAXTHAI MEDICAL EQUIPMENT CO, LTD·Product code ITJ·April 21, 2011

INSYNC II MARQUIS

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NIK·July 10, 2008

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024