11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HEMOSIL HOMOCYSTEINE AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
FDA 510(k)
FDA Class 2
·Dental
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 15, 2024
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 15, 2024
POLYAXIAL SCREW-SOLID 7.5X40MM
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HWC·April 11, 2013
FLOSEAL HEMOSTATIC MATRIX
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·April 18, 2011
ABBOTT AXSYM SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MFG, INC.·Product code JHS·June 17, 2008
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015