9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS BUCKY VISION
FDA 510(k)
FDA Class 2
·Radiology
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
FDA 510(k)
FDA Unclassified
·Unknown
LENSAR Laser System - fs 3D (LLS-fs 3D)
FDA 510(k)
FDA Class 2
·Ophthalmic
SYNCARDIA COMPANION 2 DRIVER
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·June 13, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2013
UNKNOWN
FDA Adverse Event
Injury
·UNKNOWN·Product code DQO·January 31, 2011
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024