29 results
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42ms
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Sources: EU EUDAMED, US FDA
PERIMETRICS, INC
FDA registration
PERIMETRICS, INC·1 product·🇺🇸 United States
InnerView® System Smart Tips
FDA UDI
Perimetrics, Inc.·00860011518334·Non-sterile, single-use disposable tips intende...
InnerView® System Disposable Tips
FDA UDI
Perimetrics, Inc.·10860011518324·Non-sterile, single-use disposable tips intende...
InnerView® System Base Station
FDA UDI
Perimetrics, Inc.·00860011518310·InnerView System Base Station
InnerView® System Handpiece
FDA UDI
Perimetrics, Inc.·00860011518303·QPD Measurement Instrument
PERIMETER MEDICAL IMAGING AI, INC.
FDA registration
PERIMETER MEDICAL IMAGING AI, INC.·2 products·🇨🇦 Canada
Specimen Immobilizer
FDA UDI
Perimeter Medical Imaging AI, Inc.·00754016215025·The OTIS 2.1 system includes a single-use speci...
S-Series OCT
FDA UDI
Perimeter Medical Imaging AI, Inc.·00754016215049·The OTIS 2.1 Optical Coherence Tomography Syste...
THiA
FDA UDI
Perimeter Medical Imaging AI, Inc.·00754016215018·The OTIS 2.1 Optical Coherence Tomography Syste...
Claire OCT System
FDA UDI
Perimeter Medical Imaging AI, Inc.·00754016215056·
Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HJB·November 14, 2011
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HPT·August 17, 2012
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·July 10, 2013
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·July 10, 2013
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·May 23, 2013
Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·May 23, 2013
Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 10, 2011
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
FDA Recall
Terminated
·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019