| 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. |
| K990752 |
03/08/1999 |
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
| K990750 |
03/08/1999 |
DERMAGRIP POWDER FREE BLUE 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 |
