11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Burr
FDA UDI
KATENA PRODUCTS, INC.·00841668113080·BURR FOR ALGERBRUSH 0.5MM
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexible 19G EBUS Needle
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EZ-Tip
FDA UDI
Coopersurgical, Inc.·05060488047213·Assisted Reproduction Microtools (Pipettes)
SAMSUNG GALAXY WATCH 5 PRO (Z9NL)
FDA Adverse Event
Malfunction
·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·August 30, 2023
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·July 19, 2013
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·February 22, 2017