Medical Device/IVD
|
Manufacturer
|
Category
|
Shockwave Coronary Intravascular Lithotripsy (IVL) Catheter
|
Shockwave Medical, Inc.
|
Class III
|
EnCor Breast Biopsy Probe with Rinse Tube
|
SenoRx, Inc.
|
Class III
|
HydroFill Embolic System
|
MicroVention, Inc.
|
Class III
|
Diacap Pro High Flux Dialyzer
|
B.Braun Avitum AG
|
Class III
|
Lumipulse® Pepsinogen I/II Controls
|
Fujirebio Inc.
|
Class III
|
Transcatheter Leadless Pacing System
|
Medtronic Inc.
|
Class III
|
Guiding Catheter
|
Balt Extrusion SAS
|
Class III
|
OptiBond S
|
Kerr Corporation
|
Class III
|
Contour Ureteral Stent
|
Boston Scientific Corporation
|
Class III
|
Flow Re-Direction Endoluminal Device System
|
MicroVention,Inc.
|
Class III
|
Shockwave Peripheral Intravascular Lithotripsy(IVL) Catheter
|
Shockwave Medical, Inc.
|
Class III
|
Intravascular Lithotripsy Generator and Connector Cable
|
Shockwave Medical, Inc.
|
Class III
|
LithoVue Single-Use Digital Flexible Ureteroscope
|
Boston Scientific Corporation
|
Class III
|
LigaSureTM Retractable L-Hook Laparoscopic Sealer/Divider
|
Covidien llc
|
Class III
|
Hydrophilic Acrylic Intraocular Lens
|
Rayner Intraocular Lenses Limited
|
Class III
|
Dragonfly OpStar Imaging Catheter
|
Abbott Medical
|
Class III
|
Dental Implant
|
Nobel Biocare AB
|
Class III
|
Medical X-Ray Angiography System
|
Philips Medical Systems Nederland B.V.
|
Class III
|
ORISE ProKnife
|
Boston Scientific Corporation
|
Class III
|
Coagpia ControlP-N
|
SEKISUI MEDICAL CO., LTD.
|
Class III
|
Diagnostic Ultrasound System
|
Siemens Medical Solutions USA, Inc.
|
Class III
|
Laser System
|
IRIDEX Corporation
|
Class III
|
EEA Circular Stapler with Tri-Staple Technology
|
Covidien llc
|
Class II
|
Dental Carbide Burs
|
ökoDENT-Preußer OHG Dental-medizinische Präzisionstechnik
|
Class II
|
Instruments for Cystoscopy
|
AMNOTEC International Medical GmbH
|
Class II
|
SPY PORTABLE HANDHELD IMAGING (SPY-PHI) SYSTEM
|
Novadaq Technologies ULC
|
Class II
|
Stat Profile pHOx Analyzer
|
Nova Biomedical Corporation
|
Class II
|
L11 LED light source system with AIM
|
Stryker Endoscopy
|
Class II
|
Gynaecological examination chair
|
タカラメディカル株式会社
|
Class II
|
Filter
|
Covidien llc
|
Class II
|
Guidewire
|
Boston Scientific Corporation
|
Class II
|
X-ray flat panel detector system
|
Rayence Co.,Ltd.
|
Class II
|
Surgical table
|
medifa GmbH & Co.KG
|
Class II
|
Liquid Chromatography – Mass Spectrometry Systems
|
Waters Corporation
|
Class II
|
PreciControl Vitamin D total II
|
Roche Diagnostics GmbH
|
Class II
|
Bicarbonate Standard FS
|
DiaSys Diagnostic Systems GmbH
|
Class II
|
VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack
|
Ortho-Clinical Diagnostics
|
Class II
|
Insufflator
|
W.O.M. WORLD OF MEDICINE GmbH
|
Class II
|
Dental silicone rubber impression material
|
株式会社ジーシーデンタルプロダクツ
|
Class II
|
Proglider
|
Maillefer Instruments Holding Sàrl
|
Class II
|
Lens Insertion Devices
|
Bausch & Lomb, Incorporated
|
Class II
|
Easy pass guide wire
|
Medi-Globe GmbH
|
Class II
|
Porcelain piece
|
DeguDent GmbH
|
Class II
|
IVF Workstation
|
CooperSurgical, Inc.
|
Class II
|
Vitamin D total
|
Roche Diagnostics GmbH
|
Class II
|
Urinary/Cerebrospinal Fluid Protein (UCFP)
|
Siemens Healthcare Diagnostics Inc.
|
Class II
|
Anti-Thyroglobulin II (aTgII)
|
Siemens Healthcare Diagnostics Products Limited
|
Class II
|
SINGLE -USE OPTICAL FIBERS
|
Eufoton S.r.l.
|
Class II
|
UVB Phototherapy
|
Clarteis SAS
|
Class II
|
Sensor
|
Masimo Corporation
|
Class II
|
Wound Care
|
Smith & Nephew Medical Limited
|
Class II
|
Dentine desensitizer
|
American Hi Teeth Science and Technology Inc.
|
Class II
|
