19 results
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22ms
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Sources: EU EUDAMED, US FDA
IL TEST COMPLEMENT 3
FDA 510(k)
FDA Class 2
·Immunology
ZAVATION
FDA UDI
Zavation LLC·00842166152137·WHITNEY 14mmx16mm , 0deg , 07mm
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200071·Mand. 1. Molar band W-Fit left 07
Straight Edge Metal Bracket
FDA UDI
TP ORTHODONTICS INC·00192029021347·UP/LO 5-5 W/ TE CUS ...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331115493·Eth Romeo Needle Holder, self-uprighting design...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200070051·Mand. 1. Molar band W-Fit left 07
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200070501·Mand. 1. Molar band W-Fit left 07
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200070101·Mand. 1. Molar band W-Fit left 07
SAFYRE SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pure-Vu EVS System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Zimmer, Inc.·00889024076914·
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 17, 2013
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 3, 2010
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·July 8, 2014
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017