12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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