12 results
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18ms
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Sources: EU EUDAMED, US FDA
BUFFALO FILTER REPLACEMENT FILTER #BILF-100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Barco
FDA UDI
Barco NV·05415334030336·MDSC-8358 MNA CA
Cortera
FDA UDI
Xtant Medical Holdings, Inc.·00840311209231·Guidewire, Nitinol, Threaded Tip, 450
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515238367·Joseph Perio Elev, lt cve, 4mm
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
FDA 510(k)
FDA Class 2
·Radiology
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·November 18, 2010
IBOND TOTAL ETCH
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH·Product code KLE·January 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 11, 2014
CENTURION Vision System
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQC·May 24, 2016
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQL·April 15, 2015
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HRM·May 25, 2017