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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

Sw Technologies, Inc.

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

Manual Wheelchair (MS01);Manual Wheelchair (MA01)

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)

Kanglongda Vietnam Protection Technology Company Limited

Powder Free Nitrile Examination Gloves Non-Sterile Black

Hartalega NGC Sdn. Bhd.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

Rehasense USA, Inc.

ICON 35; ICON 45; ICON 60; ICON 30FAF

RxSight® Insertion Device

Vista Industries,, LLC

Nitrile Disposable Examination Gloves

S&S Glove Corporation

Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl

Anhui Longway Medical Technology Co., Ltd.

Manual Wheelchair (LW01108)

Motion Composites

Helio Kids; Apex P

BD Diagnostic Systems

BD BACTEC FXI Culture System

Protect Gloves Company Limited

Sterile Latex Powder Free Surgical Gloves

Guangdong Dayang Medical Technology Co., Ltd.

Manual Wheelchair (DY01903(2))

Hangzhou AllTest Biotech Co., Ltd.

AllTest Strep A Rapid Test

Foshan Nanhai Hongchen Medical Equipment Co., Ltd.

Manual Wheelchair (7101L, 7102LHD)

Immunodiagnostic Systems Limited

IDS-iSYS Total Testosterone

Basic Medical Technology, Inc.

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

Miracell Co., Ltd.

SMART M-CELL Bone Marrow Concentration System

Miracell Co., Ltd.

SMART M-CELL PRP Concentration System

Medical Imaging Calibration Feature (MICF)

Zhenjiang Assure Medical Equipment Co., Ltd.

K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))

Hangzhou Clongene Biotech Co., Ltd.

Clungene RSV Antigen Rapid Test

Saeshin Precision Co., Ltd.

Motor Handpiece and Control Unit (SDI10)

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

Manual Wheelchair (W50)

Basic Medical Technology, Inc.

Syntex Exam Gloves

Cardinal Health Nitrile Examination Gloves Extended Cuff

Kossan International Sdn Bhd

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

Dentalez, Inc., Stardental Division

Star E900 Electric System

Foshan Topmed Dental Co., Ltd.

High speed air turbine handpiece

Foshan Topmed Dental Co., Ltd.

Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)

Empower Ride, LLC

EmpowerRide NAVIGATOR

Healgen Scientific,, LLC

Healgen® URS Test Strips

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

Manual Wheelchair (W45)

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

Manual Wheelchair (W47)

ACON Laboratories, Inc.

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Medical Wire & Equipment Company (Bath), Ltd.

Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

Suzhou Master Machinery Manufacturing Co.,Ltd

Manual Wheelchair (HM305-Air1, HM305-Air2)

Mercator Medical (Thailand), Ltd.

Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Karma Mobility Co, Ltd.

Flexx Junior (FLX-J00, FLX-J50)

Midmark Corporation

Midmark Dental Delivery System

Hangzhou AllTest Biotech Co., Ltd.

AllTest Urinary Tract Infection Test

Viet Phu Trade and Import Export Co., Ltd.

Disposable Vinyl Examination Gloves

Hartalega NGC Sdn. Bhd.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Program Insite, LLC

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

Alpha Endo Handpiece (Alpha Endo)

Coloplast Corp.

Ningbo Shenyu Medical Equipment Co.,Ltd

Manual Wheelchair (SYIV100A008)

Jinan Babio Biotechnology Co., Ltd.

Babio® Virus Transport Kit (Non-inactivating)

Perimetrics, Inc.

InnerView System

ACCUJECT Injector Set 2.1-1P (LP604590)

Premium Plus (Dongguan) Limited

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Basic Medical Technology, Inc.

Powder-Free Vinyl Exam Gloves, clear

Basic Medical Technology, Inc.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Dentsply Sirona, Inc.

Motor and Apex Module (MaAM)

Advanced Technology Research (A.T.R.) S.R.L.

EnDrive (EnDriveUS)

Ever Global (Vietnam) Enterprise Corporation

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

Harps Europe Manufacturing GmbH

Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

O&M Halyard, Inc.

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

Pearl Diagnostics, Inc.

MycoMEIA Aspergillus Assay

Hartalega NGC Sdn. Bhd.

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff

Lymphatech, Inc.

LymphaTech Mobile 3D Measuring Tool

Micro-Nx Co., Ltd.

ELEC ENGINE (Model: ISE-170L)

Osstem Implant Company., Ltd. Chair Business

K5 Cart, K5 Mount, K5 Swing

Basic Medical Technology, Inc.

Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

Encompass Industries Sdn. Bhd.

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Zibo Shengkun Chemical Industry Co., Ltd.

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Guangdong Yadeng Medical Apparatus Co., Ltd.,

Integral Dental Unit

Digital Prism Correction Feature (DPCF)

O&M Halyard, Inc.

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

Kl-Kepong Rubber Products Sdn. Bhd.

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Mah Sing Healthcare Sdn. Bhd.

Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Pacific Care Limited

Disposable Prophy Angle

Mipont Medical Equipment Co., Ltd.

Integral Dental Units

Basic Medical Technology, Inc.

Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Comfort Rubber Gloves Industries Sdn. Bhd.

Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

Shenzhen Rogin Medical Co., Ltd.

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

Gmp Medicare Sdn. Bhd.

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

Guilin Aesthedent Medical Instruments Co., Ltd.

Dental Implant Unit

Hangzhou AllTest Biotech Co., Ltd.

AllTest Viral Transport Medium

Apex BioTechnology Corp.

UASure II Blood Uric Acid Monitoring System

Careglove Global Sdn. Bhd.

Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

Dentis Co., Ltd.

Safesource Direct, LLC

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

Better Care Plastic Technology Co., Ltd.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Anhui Jbh Medical Apparatus Co., Ltd.

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

W&H Dentalwerk Bürmoos GmbH

Synea Fusion Handpieces (Intensiv & Profin)

Lingshi Hongruida Health Protection Technology Co., Ltd.

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Dci International, LLC

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

Basic Medical Technology, Inc.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

Bdc Dental Corporation , Ltd.

BDC Dental Unit

Ever Global (Vietnam) Enterprise Corporation

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine

Basic Medical Technology, Inc.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)

Firstar Dental Company

Firstar Dental Unit

Sunray Medical Products, Inc.

Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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