15 results · 21ms · Sources: EU EUDAMED, US FDA

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RapidVac Smoke Evacuator System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BANTAM CATHETER (280MM BALLOON LENGTHS)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 5, 2014

2520274-2013-02916

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·June 3, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·June 20, 2011

ADVANCE

FDA Adverse Event
Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

CPX4 PLUS SMOOTH TALL HEIGHT 550CC

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

da Vinci S / Si Surgical System IS2000 / 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

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, 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

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