7 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·April 28, 2021
Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 25, 2018
Nussloch GmbH ASP6025 Tissue Processor
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·July 12, 2017
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·August 7, 2013
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