14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KESTREL LENS CASE 1543-893S/P-1700-2611
FDA 510(k)
FDA Class 2
·Ophthalmic
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020551·Barricade Coil System (BCS) is intended for the...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746099007·DB BRACKET MASTER SERIES MAND RIGHT CUSPID 022 ...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746096570·DB BKT MASTER IBD UL LAT 022 T+14 A+9 R=0
CONLIN MOLAR BANDS
FDA UDI
Ortho Arch Company Inc·D90990005415·MOLAR BAND CONLIN RX LOWER LEFT 40 1/2
Palladian™
FDA UDI
NEUROSTRUCTURES, INC·00841508107002·Seat Positioner
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
FDA 510(k)
FDA Unclassified
·Unknown
ATLAS IMPLANT SYSTEM - WIDE PLUS
FDA 510(k)
FDA Class 2
·Dental
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 27, 2014
MODEL NOT SPECIFIED
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·November 8, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012