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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

Rapid Medical Ltd.

Drivewire 35 Guidewire

Biofire Defense, LLC

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Virasoft Corporation

Lg Electronics.Inc

LED LCD Monitor (OEV-271H)

Assure Tech., LLC

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup

Beijing Nubway S&T Co., Ltd.

Diode laser hair removal machine (QDTM-04)

Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM

Natural Cycles Nordic AB

LoFric Origo Pro Coudé

Hunan Qinghao Puzhong Technology Co., Ltd.

Dental Zirconia Blank & Coloring Liquid

Medtronic Sofamor Danek USA, Inc.

Catalyft PL Expandable Interbody System

Cubresa BrainPET

Carl Zeiss Meditec, AG

ZEISS CLINIC 360

Shenzhen Chuanghong Zhilian Technology Co., Ltd.

CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )

Scientia Vascular, Inc.

Socrates Aspiration System (Socrates 70 Aspiration Catheter)

Beijing Nubway S&T Co., Ltd.

Skin Air Cooling System (QALF-01)

KARL STORZ SE & CO. KG

Endomat Select (UP220)

Pioneer Surgical Technology, Inc.

Cable-Ready® Cable Grip System

Bethesda Medical Devices, LLC

Palisades Buttress Plate System

Roche Molecular Systems, Inc.

UPlanner B.V. - Presurgeo

SkeletonPlanner

ThinkSono Guidance

Aventus Thrombectomy System

CMT Health PTE., Ltd.

Profoject Pen Needles (Model A; Model B)

Atlas Spine, Inc.

Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant

Better Diagnostics AI Corp.

Better Diagnostics Dental Assist (BDDA) Version 1.0

Dongguan Miqiang Technology Co., Ltd.

XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)

Kyocera Medical Technologies, Inc.

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

EnSite X EP System

Hamamatsu Photonics K.K.

NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system

Affirm Medical Technologies II, LLC

Alphatec Spine, Inc.

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

Jochu Technology Co., Ltd.

IERO Mobility Scooter (IERO-01)

Accoat Guide Wire

Intuitive Surgical, Inc.

Universal Seal (5-12 mm)

Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

Medtronic Sofamor Danek USA, Inc.

Symmetrix L Spinal System

Merit Medical Ireland , Ltd.

Merit MAK Nitinol/Gold-Tungsten Guide Wire

SLIM Microcatheter

Rapid Vessel Occlusion (Rapid VO)

embecta Medical II, LLC

Ultra-Fine SAFETY Insulin Syringe

Shenzhen TPH Technology Co., Ltd.

Wearable Breast Pump (Model S32A)

Meta Platform Technologies, LLC

Capenergy Medical S.L.

Capenergy C Equipments RF C200 and C400 Drakarian

ACON Laboratories, Inc.

Flowflex Plus RSV + Flu A/B + COVID Rapid Test

Cochlear Americas

Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System

Boston Scientific Corporation

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Philips Medical Systems B.V.

SmartCT (R3.0 (L10))

MedSource Labs, LLC

ClearSafe Closed System

Free Flow Medical, Inc.

LungFlow Airway Catheter

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component

Zhejiang Lumbre Electric Appliance Co., Ltd.

Electric Wheelchair (DY611A-2, DY612A-1)

C.R. Bard, Inc.

Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)

Signus Medinzintechnik GmbH

Masimo Corporation

SedLine Sedation Monitor

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Sofia Lyme FIA; Sofia 2 Campylobacter FIA

New York Embroidery Studio

NYES Tuff Cuff L3 Disposable Gowns

Varian Medical Systems

AI Contouring (VA10A)

Teleflex Medical, LLC

Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

Procept Biorobotics

HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)

MedSource Labs, LLC

MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter

Synergen Technology Labs, LLC

ScioCardio ECG Analysis Platform

DiaDent Group International

PINKSLIP Water-Based Personal Lubricant and Moisturizer

Zeta Surgical, Inc.

Zeta TMS Navigation System

Smith & Nephew, Inc.

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Medtronic MiniMed

SmartGuard Technology; Predictive Low Glucose Technology

LifeLens Technologies, Inc.

LifeLens Physiological Monitor

Lifesignals, Inc.

UbiqVue 2AYe Cardiac System (UX2253)

Millipede88 Access Catheter

Stihler Electronic GmbH

ThermAffyx(TM) Patient Safety System

C.A. Medical, LLC

C.A. Medical Interbody Fusion System

Newclip Technics

BlueDop Medical, Ltd.

BlueDop Vascular Expert

Ningbo Resshidi Medical Devices Co., Ltd.

Electric Wheelchair

Roche Molecular Systems, Inc.

cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems

Formlabs Ohio, Inc.

Denture Base Resin V2

Varian Medical Systems, Inc.

Virtual Cone (1.0)

bioMerieux, Inc.

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Neurocareai, Inc. (Dba Savelife.Ai)

Mirion Technologies (Capintec), Inc.

Pulmonex II Xenon System (132-503)

HOYA Lamphun , Ltd.

HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

Yongkang Ruihe Metal Product Co., Ltd.

Electric wheelchair (XW-LY007 )

Beijing Infervision Healthcare Medical Technology Co., Ltd.

InferOperate Suite

Yongkang Ruihe Metal Product Co., Ltd.

Mobility Scooter (R200)

Hartman Medical Group, LLC

Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

GC America, Inc.

Cytrans Elashield

SteriLance Medical (Suzhou), Inc.

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

Plum Vagiceuticals Vaginal Moisturizing Suppositories

INDIGO TECHNOLOGIES

INDIRA CLOUD VIEWER

Waldemar Link GmbH & Co. KG

MobileLink Acetabular Cup System 40mm ID Inserts (various)

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

Avinent Implant System S.L.U.

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