Medical Device/IVD
|
Manufacturer
|
Category
|
Captivator Cold Single-Use Polypectomy Snare
|
Boston Scientific Corporation
|
Class III
|
Air Optix Plus Hydraglyde For Astigmatism Soft Contact Lens
|
Alcon Laboratories, Inc.
|
Class III
|
Cranial Fixation Sterile Set
|
Rebstock Instruments GmbH
|
Class III
|
Diagnostic Ultrasound System
|
Siemens Medical Solutions USA, Inc.
|
Class III
|
Radiation Treatment Planning System
|
Elekta Solutions AB
|
Class III
|
Patient Monitor
|
Philips Medizin Systeme Böblingen GmbH
|
Class III
|
OMNIset TPE
|
B.Braun Avitum AG
|
Class III
|
Dental Implant
|
Nobel Biocare AB
|
Class III
|
SURGICEL FIBRILLAR Absorbable Hemostat
|
Ethicon, LLC
|
Class III
|
Guidewires
|
日本ライフライン株式会社
|
Class III
|
Legion System and Accessories
|
Alcon Laboratories, Inc.
|
Class III
|
ArthroCare ENT Plasma Wands
|
ArthroCare Corporation
|
Class III
|
LIAISON® XL murex HCV Ab
|
DiaSorin S.p.A.
|
Class III
|
Idylla™ System
|
Biocartis NV
|
Class III
|
Lasersystem for assisted reproduction
|
Vitrolife GmbH
|
Class III
|
Ennovate Spinal System Implants
|
Aesculap AG
|
Class III
|
Titanium Suture Anchor
|
Arthrex,Inc.
|
Class III
|
AQUACEL® Foam Pro Dressing
|
ConvaTec Limited
|
Class III
|
Soft hydrophilic contact lens
|
株式会社メニコン
|
Class III
|
HD-Tubing systems Accessories
|
Fresenius Medical Care AG & Co. KGaA
|
Class III
|
Computed tomography x-ray system
|
GE MEDICAL SYSTEMS,LLC
|
Class III
|
VNS Therapy System
|
LivaNova USA, Inc.
|
Class III
|
Surgical Microscope
|
Carl Zeiss Meditec AG
|
Class III
|
BIOSURE REGENESORB Interference Screw
|
Smith & Nephew Inc., Endoscopy Division
|
Class III
|
Tracheostomy Tube
|
Covidien llc
|
Class II
|
Lens Fragmentation Device
|
Carl Zeiss Meditec AG
|
Class II
|
GARDIAN TM 25 mm SYRINGE FILTERS
|
Pall Medical, a Division of Pall International Sàrl
|
Class II
|
Dental Ceramics
|
Institut Straumann AG
|
Class II
|
Stat Profile Prime Plus Auto QC Cartridge
|
Nova Biomedical Corporation
|
Class II
|
VITEK 2 AST-YS08
|
BIOMERIEUX S.A.
|
Class II
|
Stimulator for Functional Electrical Stimulation
|
HASOMED GmbH
|
Class II
|
Body Composition Analyzer
|
InBody Co., Ltd.
|
Class II
|
Insufflator
|
Aesculap AG
|
Class II
|
Hawkins Breast Localization Needle
|
Argon Medical Devices, Inc.
|
Class II
|
Minivette® POCT
|
SARSTEDT AG & Co. KG
|
Class II
|
Hawkins Breast Localization Needle
|
Argon Medical Devices, Inc.
|
Class II
|
Angel of Water Colon Hydrotherapy System
|
Lifestream purification Systems, LLC
|
Class II
|
qUAntify Plus Control
|
Bio-Rad Laboratories, Inc.
|
Class II
|
Erythropoietin (EPO)
|
Siemens Healthcare Diagnostics Inc.
|
Class II
|
Medical Image Processing Software
|
Vital Images, Inc.
|
Class II
|
Looking Glass 4K Integrated Visualization System
|
ConMed Corporation
|
Class II
|
EV3.0 Camera Control Unit
|
Aesculap AG
|
Class II
|
EEG recorder
|
lifelines Ltd.
|
Class II
|
Medical cooling therapeutics
|
日本シグマックス株式会社
|
Class II
|
Stat Profile Prime Plus Calibrator Cartridge
|
Nova Biomedical Corporation
|
Class II
|
CalSet Vitamin D total III
|
Roche Diagnostics GmbH
|
Class II
|
PreciControl Vitamin D total II
|
Roche Diagnostics GmbH
|
Class II
|
Videocolposcope
|
Karl Kaps GmbH & Co. KG
|
Class II
|
Fundus Camera
|
Natus Medical Incorporated DBA Excel-Tech Ltd.(XLTEK)
|
Class II
|
Autorefractometer
|
株式会社ニデック
|
Class II
|
GIA stapler and cartridge with Tri-Staple technology
|
Covidien llc
|
Class II
|
Gentlefile
|
MedicNRG Ltd
|
Class II
|
RAPIDEC CARBA NP
|
BIOMERIEUX S.A.
|
Class II
|
Quantification Toolbox
|
Bracco Suisse S.A.
|
Class II
|
VIVIEDO VIEDO PROCESSOR
|
HOYA株式会社
|
Class II
|
Video endoscope
|
富士フイルム株式会社
|
Class II
|
Dosimetry Systems
|
IBA Dosimetry GmbH
|
Class II
|
