11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pentacam AXL
FDA 510(k)
FDA Class 2
·Ophthalmic
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055134·
ALP 501 RB PUMP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VITEK 2 GRAM NEGATIVE TIGECYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMICANA, S.A·Product code LHC·November 15, 2015
THERAKOS CELLEX SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·October 3, 2014
CAPSURE Z 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
ELEKTA LIMITED Elekta Synergy, 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