15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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