11 results · 19ms · Sources: EU EUDAMED, US FDA

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Sonoma Fibula Repair System

FDA 510(k)
FDA Class 2 ·Orthopedic

AURA CPAP SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

PEDIACYN ATOPIC DERMATITIS HYDROGEL

FDA 510(k)
FDA Unclassified ·Unknown

SHILEY

FDA Adverse Event
Injury ·COVIDIEN·Product code JOH·May 29, 2013

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·June 21, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015