13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Meridian Vaginal Positioning System (VPS)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
n/a
FDA UDI
Ortho Development Corporation·00822409111091·Tibial Cut Guide Closed 0 Degree Left
Echotip
FDA UDI
COOK INCORPORATED·00827002163751·Echotip Disposable Lancet Needle
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
FDA 510(k)
FDA Class 2
·Microbiology
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SONOSURG SCISSORS 5MM O.D., HF SERIES
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·June 12, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·July 23, 2011
MICROSCAN PANELS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LRG·October 10, 2014
HUDSON CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS
FDA Adverse Event
Death
·TELEFLEX·Product code CAG·July 2, 2014
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021