23 results
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23ms
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Sources: EU EUDAMED, US FDA
AeroEclipse* ONE BAN
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCUTRAY
FDA UDI
MEDICAL ACTION INDUSTRIES INC.·10809160001615·
IBP Interface cable (PvB 6300 - PvB – Codan)
FDA UDI
MIPM Mammendorfer Institut für Physik und Medizin GmbH·EMIP52000630·
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040187647·ZIRLUX ML DISC A1 98x18
IBP Interface cable (PvB 6300 - PvB – Codan)
FDA UDI
MIPM Mammendorfer Institut für Physik und Medizin GmbH·04255629200690·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005906·1.3mm Pilot Drill, Manual
Drill Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111221542·Staple Drill Guide
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
NP1 Instrument, Creo Electrosurgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 13, 2020
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 1, 2013
NOVOSTITCH PRO MEN RPR SYS 2-0
FDA Adverse Event
Injury
·CETERIX ORTHOPAEDICS, INC·Product code GAT·January 7, 2021
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·April 27, 2020
Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014