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Ablation Catheter Surgical Imaging Diagnostic All medical devices

All classes Class I Class II Class III100 entries · live · openFDA

510(k)

Sponsor

Device

Class

Cleared

Paragon 28, Inc.

Primal K-Wire (P99-193-1410)

Roche Molecular Systems, Inc.

cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)

Reflow Medical, Inc.

Kiba CTO Crossing Catheter

GE Healthcare Finland Oy

Carescape Canvas 1000; Carescape Canvas Smart Display

Roche Molecular Systems, Inc.

cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)

Medtronic, Inc.

LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

Ortler Global Tibbi Gerecler Anonim Sirketi

FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)

Rapid Medical Ltd.

Tigertriever 13 Ultra Revascularization Device

Medacta International S.A.

Mpact 3D Metal Foam

CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)

Zhejiang Curaway Medical Technology Co., Ltd.

Automatic Core Biopsy Instrument

Imperative Care, Inc.

Zoom 4S Catheter

X-Nav Technologies, LLC

X-Guide Surgical Navigation System

Beijing Fule Science & Technology Development Co., Ltd.

Fule Vertebroplasty Balloon Catheter

Rayvolve AZchest

Scarlet Pro (Scarlet Pro)

Olympus Medical Systems Corporation

EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)

Ram.Shaw Pte., Ltd.

Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

Riverpoint Medical

Iconix Knotless T

Stereotaxis, Inc.

Prismatik Dentalcraft, Inc.

Glidewell Denture Base Resin

Zhengzhou PZ Laser Slim Technology Co., Ltd.

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

Gebauer Company

Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

Olympus Medical Systems Corporation

Gastrointestinal Videoscope Olympus GIF-2T1500

Fisher and Paykel Healthcare Limited

Optiflow Oxygen Kit (AA484J)

Piraeus Medical, Inc.

35 Helix Guidewire

Samsung Electronics Co., Ltd.

Zhejiang Qiangnao Technology Co.,Ltd

Dexus Prosthetic System (MSL2, MSR2)

Ascensia Diabetes Care

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System

Olympus Medical Systems Corporation

Disposable Distal Attachment D-201-13404

Berkeley Advanced Biomaterials

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

GraftGun Universal Graft Delivery System (GDS®)

Principle & Will Co., Ltd.

Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns

StimTrial Neuromodulation System

Oticon Medical AB

Ponto 5 Mini; Ponto 5 Superpower

Manteia Technologies Co., Ltd.

MRIA Radiation Therapy Information System (MRIA)

Wenzel Spine, Inc.

VariLift-C Cervical Interbody Fusion System

Maquet Critical Care AB

Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

JOYTECH Healthcare Co., Ltd.

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)

Karl Storz SE & CO. KG

HOPKINS Telescopes for Arthroscopy

Boston Scientific Corporation

LithoVue Elite Digital Flexible Ureteroscope System

Sony Corporation

OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor

Heartvue.ai, Inc.

Heartvue.Proton

Guilin Kevin Peter Technology Co., Ltd.

Calcium Hydroxide Temporary Filling Material (KP-Cal)

Ceevra Reveal 4

Sol-Millennium Medical, Inc.

SOL-M Luer Lock Syringe with Exchangeable Needle Tray

Taiwan Surgical Corporation

Inno-Switch Laparoscopic Instruments

Beacon Biosignals, Inc.

Promisemed Hangzhou Meditech Co., Ltd.

Promisemed X-Safety Pen Needle

SteriLance Medical (Suzhou), Inc.

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

Achaemenid, LLC

iNOS intraoral biosensor

Samyang Holdings Corporation

Flower Orthopedics Corporation DBA Conventus Flower Orthoped

OsteoCoil GT Active Compression System

BiWaze Clear System

Bolt Medical, Inc.

SEISMIQ Intravascular Lithotripsy System

Biomet Orthopedics, Inc.

Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments

TiLink-L SI Joint Fusion System

Sonoscape Medical Corp.

Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)

DentalMaster(Xiamen)Medical Technology Co., Ltd.

Guided Bone Regeneration System

BTL Industries, Inc.

GM Dos Reis Industria e Comercio Ltda.

Stitch - Suture Wires and Tapes

Apyx Medical Corporation

AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors

Foshan Sowell Medical Technology Co., Ltd.

Electric wheelchair (D03)

Boston Scientific

AVVIGO+ Multi-Modality Guidance System

Immunodiagnostics Systems Limited

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

Mriguidance B.V.

Hangzhou Tappa Medical Technology Co., Ltd.

Disposable Warming Blanket

Microport Orthopedics, Inc.

EVOLUTION® AM BIOFOAM® Tibial System

Zeus Scientific

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

Cimilre Co., Ltd.

Cimilre Dual Max

Medtronic, Inc.

Affera Integrated Mapping System

Solo Scope Colonoscope System

Mediclus Co., Ltd.

Dentsply Sirona

DS Core CBCT Anatomy

Osseus Fusions Systems, LLC

Pisces-SC Standalone Cervical Interbody System

Shanghai United Imaging Healthcare Co., Ltd.

uAngio AVIVA CX

Tempus AI, Inc.

Inari Medical, Inc.

Artix MT;Artix Thin-Walled Sheath

Convergence Medical Sciences , Ltd.

Valence InVent Xtend (CVG-4101-VXA)

Virtual Incision

MIRA Surgical System

Guangdong Youmeng Electrical Technology Co., Ltd.

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Draeger Medical Systems, Inc.

Infinity® Acute Care System (IACS) VG8.1

Hardy Diagnostics

HardyDisk AST Tebipenem 10µg (TBP10)

Kneu Health Digital , Ltd.

Kneu Platform (V2)

Remex Medical Corp.

Remex Spine Surgery Navigation - Universal Instruments

CPETWise Platform

Roche Diagnostics

Elecsys Phospho-Tau (217P) Plasma

Hyperfine, Inc.

Swoop® Portable MR Imaging® System

C2N Diagnostics, LLC

PrecivityAD2 Test

DRTECH Corporation

EXTRON 3;EXTRON 6

GM Dos Reis Industria e Comercio Ltda.

Versalock Sterile Plating System

Zeros Co., Ltd.

ZEROS Dental Implant System

Shokz Health Global Limited

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

Hebei Zollvan Medical Technology Co., Ltd.

Diode Laser Therapy Systems (DL612A)

Pascall Systems, Inc.

Pascall Sensor Unit (PSU1)

CooperSurgical, Inc.

Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)

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