20 results
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28ms
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Sources: EU EUDAMED, US FDA
BIOPOTENTIAL SURFACE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020605·Barricade Coil System (BCS) is intended for the...
SAFIRA
FDA UDI
MEDOVATE LIMITED·05060727270068·SAFIRA System hand operator for controlling SAF...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746099410·DB BRACKET MASTER SERIES MAND LEFT 2ND BICUSPID...
CONLIN MOLAR BANDS
FDA UDI
Ortho Arch Company Inc·D9099000591·MOLAR BAND CONLIN RX LOWER LEFT 43
XBraid TT
FDA UDI
RIVERPOINT MEDICAL, LLC·00810020084979·Suture Tape
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 3, 2020
Contrast Media, Ultrasound
FDA Pre-Market Approval
FDA Class 3
·ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
Contrast Media, Ultrasound
FDA Pre-Market Approval
FDA Class 3
·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Contrast Media, Ultrasound
FDA Pre-Market Approval
FDA Class 3
·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Contrast Media, Ultrasound
FDA Pre-Market Approval
FDA Class 3
·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
TT AUGMENTED 360 BASEPLATE #S-R 15°
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·January 3, 2024
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644465040·
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 27, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 9, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 26, 2012
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 7, 2018