| K915704 |
11/27/1991 |
AMYLASE (KINETIC) REAGENT SET |
TECH INTL. CO. |
| K230174 |
01/20/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
| K230164 |
01/20/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
| K230163 |
01/20/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
| K230739 |
03/17/2023 |
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 |
Shenzhen IONKA Medical Technology Co., Ltd. |
| K221214 |
04/27/2022 |
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
Shenzhen IONKA Medical Technology Co., Ltd. |
| K211864 |
06/16/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Siyang Jaysun Medtech Co., Ltd. |
| K161151 |
04/25/2016 |
Spinal fixation system |
CANWELL MEDICAL CO., LTD. |
| K142943 |
10/10/2014 |
Metallic Locking Bone Plate and Screw |
Canwell Medical Co., Ltd |
| K240364 |
02/06/2024 |
RELIEEV Uterine Manipulator Injector (CUMI 5.0) |
LI Medical Corporation Ltd. |
| K231969 |
07/03/2023 |
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) |
Dongguanshi Yiyingmei Technology Co., Ltd. |
| K230641 |
03/08/2023 |
Ultrasonic Scaler Tips |
Guilin Refine Medical Instrument Co., Ltd. |
| K223414 |
11/10/2022 |
Curing Light, Model: MaxCure 9 |
Guilin Refine Medical Instrument Co., Ltd. |
| K212526 |
08/11/2021 |
Surgical Face Mask |
Suzhou JaneE Medical Technology Co., Ltd. |
| K212591 |
08/16/2021 |
Disposable Surgical Gown |
Suzhou JaneE Medical Technology Co., Ltd |
| K221116 |
04/15/2022 |
XACT ACE Robotic System |
XACT Robotics Ltd. |
| K191332 |
05/16/2019 |
XACT Robotic System |
XACT Robotics Ltd. |
| K201586 |
06/11/2020 |
XACT Robotic System |
XACT Robotics Ltd. |
| K240284 |
02/01/2024 |
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) |
Shenzhen Browiner Tech Co., Ltd |
| K221499 |
05/23/2022 |
Minimally Invasive Prostate Surgery Navigation System |
Augment Intelligent Medical System (China) Co., Ltd. |
| K242195 |
07/26/2024 |
Gemini Cervical Fusion Cage System |
ZheJiang Decans Medical Devices Co., Ltd. |
| K221352 |
05/10/2022 |
Surgical Face Mask |
Wuhan Huashida Protective Products Co., Ltd. |
| K210020 |
01/04/2021 |
Medical Mask |
Zhende Medical Co., Ltd. |
| K201729 |
06/24/2020 |
Medical Mask |
Zhende Medical Co., Ltd |
| K211257 |
04/26/2021 |
EFAI PACS Picture Archiving and Communication System |
Ever Fortune.AI Co., Ltd. |
| K212624 |
08/18/2021 |
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
Ever Fortune. AI Co., Ltd. |
| K233761 |
11/24/2023 |
Orthopaedic Surgery Planning Software (AIJOINT) |
Longwood Valley Medical Ltd |
| K210025 |
01/04/2021 |
INVU by Nuvo |
Nuvo-Group Ltd. |
| K221046 |
04/08/2022 |
Invu by Nuvo |
Nuvo- Group Ltd. |
| K242611 |
09/03/2024 |
Integral Dental Units |
Mipont Medical Equipment Co., Ltd. |
| K242646 |
09/03/2024 |
Dental Implant Unit |
Guilin AestheDent Medical Instruments Co., Ltd |
| K123861 |
12/14/2012 |
AIDI DENTAL IMPLANT SYSTEM |
AIDI BIOMEDICAL LLC |
| K173017 |
09/27/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
| K173016 |
09/27/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
| K102372 |
08/20/2010 |
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB |
JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO |
| K092634 |
08/27/2009 |
OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF |
JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO |
| K223055 |
09/29/2022 |
Disposable Medical Face Mask |
Xiantao Zhuobo Industrial Co., LTD |
| K172965 |
09/26/2017 |
Handheld VitalSigns Monitoring System |
Visiomed Technology Co.,Ltd |
| K221799 |
06/21/2022 |
Electric Wheelchair, Model: 9000N |
Silver Fox Corporation Limited |
| K230237 |
01/30/2023 |
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) |
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. |
| K240287 |
02/01/2024 |
LYHER« Oral fluid Multi-Drug Test Kit (Cube) |
Hangzhou Laihe Biotech Co., Ltd. |
| K173228 |
10/04/2017 |
U-MED Powder Free Polyethylene Examination Gloves,Blue Color |
Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. |
| K230115 |
01/17/2023 |
Denture Base Resin |
Aidite (Qinhuangdao) Technology Co., Ltd |
| K222626 |
08/31/2022 |
Dental Zirconia Ceramic |
Aidite (Qinhuangdao) Technology Co., Ltd. |
| K223477 |
11/18/2022 |
PMMA Blocks for Dental Use |
Aidite (Qinhuangdao) Technology Co., Ltd. |
| K223742 |
12/14/2022 |
Dental Ceramic Blocks |
Aidite (Qinhuangdao) Technology Co., Ltd |
| K050154 |
01/24/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. |
| K050155 |
01/24/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. |
| K030529 |
02/19/2003 |
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE |
JDA (TIANJIN) PLASTIC RUBBER CO., LTD. |
| K042119 |
08/06/2004 |
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
| K042120 |
08/06/2004 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
| K032783 |
09/08/2003 |
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
| K032781 |
09/08/2003 |
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
| K032907 |
09/17/2003 |
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
| K032908 |
09/17/2003 |
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
| K043475 |
12/16/2004 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
| K043477 |
12/16/2004 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
| K191276 |
05/13/2019 |
Dental Electrical Motor iRoot Pro |
ChangZhou BoMedent Medical Technology Co., Ltd. |
| K232499 |
08/17/2023 |
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) |
Shenzhen Lescolton Electrical Appliance Co., Ltd. |
| K201302 |
05/15/2020 |
LiveOne |
LiveMetric (Medical) S.A. |
| K970454 |
02/05/1997 |
LAXIMA INTERNATIONAL LIMITED SUNGLASSES |
LAXIMA INTL., LTD. |
| K191504 |
06/06/2019 |
PowerDR |
Radiology Information Systems, Inc. |
| K182411 |
09/04/2018 |
Scooter, Model: R-100 |
Yongkang Dingchang Industry & Trade Co., LTD. |
| K201982 |
07/17/2020 |
Air compression therapy system FO-3001; Air compression therapy system FO-3008 |
Foshan Hongfeng Co., Ltd |
| K212881 |
09/10/2021 |
Intense Pulsed Light (IPL) System |
Shenzhen Fansizhe Science And Technology Co., Ltd |
| K190534 |
03/04/2019 |
Manual Wheelchair SIVFH2A102 |
Jiangsu Horizon Medical Science & Technology Co., Ltd. |
| K081873 |
07/02/2008 |
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE |
SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. |
| K240563 |
02/29/2024 |
Power Wheelchair (JJW-6001) |
ZheJiang J&J Mobility Co., Ltd |
| K213731 |
11/26/2021 |
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows |
Ever Fortune.AI Co., Ltd. |
| K220103 |
01/12/2022 |
LED Therapy Device (Planar LED/Planar LED mini) |
Shenzhen Leaflife Technology Co., Ltd |
| K230362 |
02/10/2023 |
Planar LED mate |
Shenzhen Leaflife Technology Co., Ltd |
| K212697 |
08/25/2021 |
Leaf Smooth |
Shenzhen Leaflife Technology Co., Ltd |
| K202980 |
09/30/2020 |
Laser Therapy Device |
Shenzhen Leaflife Technology Co., Ltd |
| K212344 |
07/28/2021 |
Surgical Mask |
Xiantao Dingcheng Non-woven Product Co., Ltd |
| K212718 |
08/27/2021 |
Surgical gowns |
Xiantao Dingcheng Non-Woven Product Co., Ltd |
| K070473 |
02/20/2007 |
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
| K070578 |
03/01/2007 |
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
| K090027 |
01/05/2009 |
BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
| K181276 |
05/14/2018 |
CONOD Enteral Feeding Sets |
Conod Medical Co., Limited |
| K201504 |
06/05/2020 |
Single-use medical poly (vinyl chloride) examination glove |
Anhui Bytech Medical Supplies Co., Ltd. |
| K240401 |
02/09/2024 |
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) |
OriGyn Medical Technology (Hangzhou) Co., Ltd. |
| K242798 |
09/16/2024 |
Airmod |
Heroic Faith International Ltd. |
| K242971 |
09/26/2024 |
AccurSound Electronic Stethoscope (AS101) |
Heroic Faith International Ltd. |
| K210440 |
02/12/2021 |
Disposable Sampler Inactivated Transport Media, Nest ITM |
Wuxi Nest Biotechnology Co., Ltd. |
| K240774 |
03/21/2024 |
Pen Injector |
Wuxi NEST Biotechnology Co., Ltd. |
| K240961 |
04/08/2024 |
Disposable Pen Injector Assembly |
Wuxi NEST Biotechnology Co., Ltd. |
| K211256 |
04/26/2021 |
Disposable Sampler Viral Transport Media |
Wuxi Nest Biotechnology Co., Ltd. |
| K990750 |
03/08/1999 |
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
| K990752 |
03/08/1999 |
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
| K991044 |
03/30/1999 |
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
| K032461 |
08/11/2003 |
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
Lin-Zhi International, Inc. |
| K970795 |
03/04/1997 |
SHANG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
| K964819 |
12/02/1996 |
SHENG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
| K142982 |
10/15/2014 |
OPUS 5100 Diagnostic Doppler Ultrasound System |
Chang Gung Medical Technology Co., Ltd. |
| K220118 |
01/14/2022 |
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves |
KL-Kepong Rubber Products SDN. BHD. |
| K131042 |
04/15/2013 |
LEDEX |
DENTMATE TECHNOLOGY CO., LTD. |
| K221194 |
04/25/2022 |
LEDEX |
Dentmate Technology Co. Ltd. |
| K082408 |
08/21/2008 |
LEDEX, MODEL: WL-070 |
DENTMATE TECHNOLOGY CO., LTD. |
| K163605 |
12/21/2016 |
LEDEX WL070+ |
DENTMATE TECHNOLOGY CO., LTD. |
| K223126 |
10/03/2022 |
SurgiAid« Collagen Wound Dressing |
Maxigen Biotech, Inc. |
| K230529 |
02/27/2023 |
HealiAid Dental Collagen Wound Dressing |
Maxigen Biotech Inc. |
| K251315 |
04/29/2025 |
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II |
Remex Medical Corp. |
| K243560 |
11/18/2024 |
Remex Spine Surgery Navigation Instrument |
Remex Medical Corp. |
| K050733 |
03/17/2005 |
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K050945 |
04/14/2005 |
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS |
Lin-Zhi International, Inc. |
| K051058 |
04/26/2005 |
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K051088 |
04/28/2005 |
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K031797 |
06/10/2003 |
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K032365 |
07/31/2003 |
BENZODIAZEPINE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
| K032764 |
09/05/2003 |
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
| K033094 |
09/29/2003 |
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K033866 |
12/12/2003 |
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) |
Lin-Zhi International, Inc. |
| K033885 |
12/15/2003 |
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) |
Lin-Zhi International, Inc. |
| K142655 |
09/18/2014 |
CB PROT II Posterior Spinal System |
CHIN BONE TECHNIQUE CORP |
| K103015 |
10/12/2010 |
ODRC-DYNAMIC HIP SCREW SYSTEM |
ORTHOPAEDIC DEVICE RESEARCH CENTER |
| K250710 |
03/10/2025 |
Injectable Root Canal Bioceramic Sealer (nRoot SP) |
Enpuno Co., Ltd |
| K242317 |
08/05/2024 |
Integrated Endo System (Meet Endo-II) |
Denjoy Dental Co., Ltd. |
| K172543 |
08/23/2017 |
High-speed Turbine Handpieces for Single Use |
Beijing Dongbo Dental Handpiece Co., Ltd. |
| K183041 |
11/01/2018 |
Full Digital Colour Doppler Ultrasonic Diagnostic System |
Wuhan Zoncare Bio-medical Electronics Co., Ltd |
| K181870 |
07/12/2018 |
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use |
Wuhan W.E.O Science & Technology Development Co., Ltd. |
| K241686 |
06/12/2024 |
Power wheelchair (N6101) |
Zhejiang Zhonglei Medical Technology Co.Ltd. |
| K242308 |
08/05/2024 |
Power wheelchair |
Zhejiang Zhonglei Medical Technology Co. Ltd. |
| K242402 |
08/13/2024 |
Power wheelchair |
Zhejiang Zhonglei Medical Technology Co.Ltd. |
| K120181 |
01/20/2012 |
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
| K110219 |
01/25/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
WEALTH ON (JIANGSU) CO., LTD |
| K101000 |
04/12/2010 |
WELLMIEN SURGICAL MASK |
WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD |
| K102171 |
08/02/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
WUXI BINGFA GAINLITE GLOVES CP., LTD |
| K102692 |
09/20/2010 |
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO |
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. |
| K112800 |
09/27/2011 |
SUNTOUCH TOPICAL HEMOSTATIC DRESSING |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
| K143335 |
11/20/2014 |
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) |
Roosin Medical Devices Co., Ltd |
| K231929 |
06/30/2023 |
iQ-solutions |
Sydney Neuroimaging Analysis Centre Pty Ltd |
