16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RECON system-V-TEK-IVP Plates and Screws
FDA 510(k)
FDA Class 2
·Orthopedic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502109·INTERBODY 2152312 LARGE - 12 DEG 12MM
Eagle Derma2 Nitrile Examination Gloves
FDA UDI
Eagle Protect Pbc·09421024254643·Derma2 Nitrile Examination Gloves, Black, Powde...
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055158·
Sklar
FDA UDI
SKLAR CORPORATION·30649111139394·DRESS. JAR 1/2QT W/COVER PK 12
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
THERATRODE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·October 3, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 23, 2011
PEDICLE SCREW 5X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·March 23, 2018
ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024