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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

Sway Medical, Inc.

Sway System (Sports Plus)

BCS Device Pte., Ltd.

BCS Bioceramic Sealer

Sofradim Production

Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)

Bausch + Lomb, Inc.

Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens

Hong Qiangxing (Shenzhen) Electronics Limited

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

VPIX Medical, Inc.

cCeLL - In vivo

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18

Xiamen Compower Medical Tech. Co., Ltd.

Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)

Route 92 Medical, Inc.

Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

Endox Test Strips

Desarrollo e Investigación Médica Aragonesa S.L.

THINK Surgical, Inc.

TMINI Miniature Robotic System

Sensinel Cardiopulmonary Management (CPM) System

Whiteley USA, Inc.

Endox High Level Disinfectant

Becton, Dickinson and Company

BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)

Carecubes, Inc.

Carecube Negative Pressure Isolation Chamber (1BY)

Tomy International, Inc.

MODO DUO Electric Pump (B11621, B11673)

Coreline Soft Co., Ltd.

AVIEW Aorta Metrics

Skycade Med Corporation

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)

Lilium Otsuka Co., Ltd.

Lilium one (USM330)

Kossel Medtech (Suzhou) Co., Ltd.

Giranel Guiding Sheath Set

Micro-Tech (Nanjing) Co., Ltd.

Single-Use EBUS Balloon

Guangzhou Aimooe Technology Co., Ltd.

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)

Circadia Health, Inc.

The Circadia CX00 System (CX00)

Carl Zeiss Meditec Cataract Technologies

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)

Park's Pectus System

Life Technologies Corporation

Oncomine Dx Express Test

Deka Research and Development Corp.

twiist Loop Algorithm

Medyssey Co, Ltd.

INDIGO® Aspiration System

Intuitive Surgical, Inc.

da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

Karl Storz SE & CO. KG

KARL STORZ Flexible Video Neuro-Endoscope

Health Value Creation B.V. (trading as Corporis Medical)

Mediclose Cartridge System

Guangxi Hope Medical Devices Technology Co., Ltd.

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)

Vantage Lumbar Decompression Kit

Alliedstar Medical Equipment Co., Ltd.

Sterilization Cassette (CASS-1)

Masimo Corporation

Radius VSM and Accessories

Anhui JBH Medical Apparatus Co., Ltd.

Power Wheelchair (D39)

Shanghai Medi Astro Technology Co., Ltd.

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

Nvision Biomedical Technologies

Ntegrate Threaded Nail System

Shenzhen Dongdixin Technology Co., Ltd.

TECAR Therapy Device (TC2000, TC2001)

Yomi S Robotic System

Zhejiang Shimo Technology Co., Ltd.

Electric Wheelchair (CN501)

Yurob Rehabilitation Medical Co., Ltd.

Electrically Powered Wheelchair (YC-01)

Spident Co., Ltd.

OrthoFit Aligner (OrthoFit Aligner A2)

Keyue (Hangzhou) Medical Information Technology Co., Ltd.

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)

Endovascular Engineering, Inc.

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)

Neurotronics, LLC

Sleep Analysis Module

Vivachek Biotech (Hangzhou) Co., Ltd.

VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.

Stryker Neurovascular

Excelsior Reach Microcatheter

Medical Components, Inc.

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler

Allwin Medical Devices, Inc.

The D-Tip Denudation Pipette

Fujifilm Corporation

ECHELON Synergy

Fertilis Pty, Ltd.

Fertilis microICSI Device

CarboFix Orhtopedics , Ltd.

CarboClear® Cervical Navigated Instruments

Shenzhen Jianchao Intelligent Technology Co., Ltd.

IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)

Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)

TruVision Single-Use 1.9mm Arthroscopy System

CMF Titanium Splints

Ischemaview, Inc.

Rapid ICH (v4.0)

One Coat Bond; One Coat Bond SL

Wuhan Phomed Technology Co., Ltd.

CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)

IVT Medical, Ltd.

MeCare Alpha (MCA2019)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun

Samsung Medison Co., Ltd.

V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System

Paragon 28, Inc.

APEX 3D S Diamond Tibia

Beijing Nubway S&T Co., Ltd.

Diode Laser Hair Removal Machine (QDTM-03)

Centinel Spine, LLC

prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments

Ceiba Healthcare US, Inc.

InnoDtech, Inc.

Zhongshan GL Electronics Co. , Ltd.

Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)

Deep Reasoning Ai, Inc.

Centers for Disease Control and Prevention

B. anthracis Real-time PCR Assay

Urolution Medical, Inc.

OpenFlo Urinary Catheter

Tsk Laboratory, Japan

Bayer Medical Care, Inc.

MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike

Okami Medical, Inc.

LOBO Vascular Occlusion System

True Function Laboratory, Inc.

Anhui JBH Medical Apparatus Co., Ltd.

Power Wheelchair (D60)

Anhui JBH Medical Apparatus Co., Ltd.

Power Wheelchair (DC12)

NormaTec Industries, LP

Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)

APRO 88 Catheter

Shijiazhuang Recovery Star Medical Device Co., Ltd.

UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)

Inkspace Imaging, Inc.

InkSpace Imaging Small Body Array (SBA12PH15x)

Sichuan Qianli-Beoka Medical Technology, Inc.

Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)

RT Elements (4.6)

HeartSciences, Inc.

MyoVista wavECG (DG-200-B15-003)

Medis Medical Imaging Systems BV

Cognition Medical Corp.

OAB Delivery Catheter

Lg Electronics.Inc

Medical Monitor (32MD08WC)

Plenity-V (MC0979 / GS110)

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