8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SONIC MIST ULTRASONIC HUMIDIFIER
FDA 510(k)
FDA Class 1
·Anesthesiology
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
FDA 510(k)
FDA Class 2
·Ophthalmic
DISPOSABLE INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 26, 2014
AIR OPTIX NIGHT & DAY
FDA Adverse Event
Injury
·PT CIBA VISION BATAM·Product code LPM·November 9, 2012
ATTAIN STARFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 13, 2010
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018