18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRE-LOADED VISICOIL
FDA 510(k)
FDA Class 2
·Radiology
MAS PLIF
FDA UDI
Nuvasive, Inc.·00887517200914·MAS PLIF Fixation Drill, 4.5mm
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507348·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698220·Fully Guided Drill Ø2mm, Short
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699470·Paltop Equator Smart Box Housing With Black Cap
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814259·Oschner (Kocher) Forceps, Straight, 35 cm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814853·Oschner (Kocher) Forceps, Straight, 35 cm
Puritan Bennett
FDA UDI
Covidien LP·30884521101542·Re/X800 Reusable Expiratory Bacterial Filter Dr...
WEISS RETINAL CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
HARDYDISK, CEFOXITIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 22, 2013
LINOX SD 60/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code LWS·April 18, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.
FDA Recall
Terminated
·Diasorin Inc.·Product code JTC·May 20, 2004
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022