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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (K250473)Dci International, LLC2025-02-19
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) (K243792)Basic Medical Technology, Inc.2025-02-18
BDC Dental Unit (K242404)Bdc Dental Corporation , Ltd.2025-02-07
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034)Ever Global (Vietnam) Enterprise Corporation2025-02-06
VMAT PRO (K243488)Termosalud2025-02-06
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (K243441)Basic Medical Technology, Inc.2025-01-31
Firstar Dental Unit (K231297)Firstar Dental Company2025-01-27
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936)Sunray Medical Products, Inc.2025-01-15
Safecare Urinary Tract Infection Test (K242767)Safecare Biotech (Hangzhou) Co., Ltd.2025-01-10
Bowhead ERA Wheelchairs (K243111)Bowhead Design Corp.2025-01-10
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K243818)Hartalega NGC Sdn. Bhd.2025-01-08
HPR Cordless Hygiene Handpiece (K243911)Handpiece Headquarters2024-12-20
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K242558)O&M Halyard, Inc.2024-12-17
Manual Wheelchair (MASY23) (K242722)Sichuan Ast Medical Equipment Co., Ltd.2024-11-22
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (K240337)Guangdong Jinme Medical Technology Co., Ltd.2024-11-13
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (K241074)Foshan Soco Precision Instrument Co., Ltd.2024-11-12
Nitrile Powder Free Examination Gloves Biodegradable (Green) (K240269)Comfort Rubber Gloves Industries Sdn. Bhd.2024-10-25
Manual Wheelchair (SYIV100-CA9221) (K242560)Foshan Shunkangda Medical Tech Co., Ltd.2024-10-24
IDS-iSYS Free Testosterone (K240865)Immunodiagnostic Systems Limited2024-10-23
Digital Prism Correction Feature (DPCF) (K242058)Apple, Inc.2024-10-21
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (K242812)Nb Medical Company Limited2024-10-12
UriSponge™ (K232565)Copan Italia Spa2024-10-11
EyeGility™ Inserter for Preloaded enVista IOLs (K242389)Bausch & Lomb, Incorporated2024-10-10
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909)O&M Halyard, Inc.2024-09-27
TearRepair Liquid Skin Protectant (K241916)Optmed, Inc.2024-09-27
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880)Nakanishi, Inc.2024-09-20
Star E900 Handpiece Series (K240183)Dentalez, Inc., Stardental Division2024-09-19
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) (K241745)Ksg Medicare Sdn. Bhd.2024-09-11
Latex Examination Glove Powder Free (Ocean Blue and Natural White) (K240266)Sri Trang Gloves (Thailand) Public Company Limited2024-09-09
Luvis Chair (LC700C) (K233921)Dentis Co., Ltd.2024-09-06
K5 (K233805)Osstem Implant Co., Ltd. Chair Business2024-09-03
Ensol EnTM Specimen Collection and Transport System (K220908)Ensol Biosciences, Inc.2024-08-29
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (K240545)Genabio Diagnostics, Inc.2024-08-28
Cardinal Health Nitrile Exam Gloves (K241780)Cardinal Health200, LLC2024-08-23
Polyisoprene Surgical gloves (K240790)Suzhou Colour-Way New Material Co., Ltd.2024-08-23
OmniTrans Transport System (K240235)Shenzhen Dakewe Bio-Engineering Co., Ltd.2024-08-19
The Trust (K222688)Genoss Co., Ltd.2024-08-09
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (K232404)Medicon Hellas S.A2024-08-09
ADVIA Centaur EBV-EBNA IgG (K233605)Biokit, S.A.2024-08-07
ADVIA Centaur EBV-VCA IgM (K233606)Biokit, S.A.2024-08-07
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528)Comfort Rubber Gloves Industries Sdn. Bhd.2024-08-06
Viral Transport Medium (K233534)Hardy Diagnostics2024-08-02
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) (K241970)Kanglongda Vietnam Protection Technology Company Limited2024-08-02
Nano-Check™ RSV Test (K240280)Nano-Ditech Corporation2024-07-30
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (K241800)Siemens Healthcare Diagnostics, Inc.2024-07-26
X-Smart Pro; X-Smart Pro+ (K233865)Dentsply Sirona, Inc.2024-07-24
Avantik VTM (K233449)Hanchang Medic Co., Ltd. (Han Chang Medic)2024-07-15
Manual Wheelchair (K241460)Lichtmega Technology Co., Ltd.2024-07-11
Lightin System, Lightin, Lightin Generator (K232177)Solmedix Co., Ltd.2024-07-10
EM-07 Cordless Endo Motor (K232551)Forum Engineering Technologies (96) , Ltd.2024-07-09
Merlexi Craft Bariatric series of manual wheelchairs (K240120)Turbo Wheelchair Co., Inc.2024-07-05
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue (K240930)Sri Trang Gloves Thailand (Public Company Limited)2024-07-02
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) (K240824)Ningxia Qiaoen Medical Technology Co., Ltd.2024-06-25
NLZ Built-In Motor System (K233288)Nakanishi, Inc.2024-06-24
PRESSUREALERT® Pressure Monitoring System (K233096)Position Health, LLC2024-06-21
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (K233117)Nakanishi, Inc.2024-06-20
VERVE (K232930)Oculomotor Technologies2024-06-13
ShockPhysio Mobile (model SW3200 Basic) (K240358)Shenzhen Dongdixin Technology Co., Ltd.2024-06-05
Maestro System (REF100) (K240598)Moon Surgical2024-06-03
LFR-260 (K233295)Evolution Optiks Limited2024-05-31
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K240629)Xingyu Medical Tech Co., Ltd.2024-05-28
Disposable Vinyl Examination Gloves (K241252)Anqing Pukang Medical Technology Co., Ltd.2024-05-20
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) (K232614)Sri Trang Gloves (Thailand) Public Company Limited2024-05-13
Cypris eXact Suture Placement Device (K240185)Cypris Medical2024-05-03
Viral Transport Media (VTM) (K232454)Alb Luz2024-05-03
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) (K233122)Litu Tech , Ltd.2024-04-30
Copan Universal Transport Medium (UTM-RT) System (K232357)Copan Italia Spa2024-04-25
Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (K233308)Nakanishi, Inc.2024-04-25
Black Pearl Nitrile Examination Glove (K232319)Ug Global Resources Sdn. Bhd.2024-04-22
Azer Scientific Universal Transport Medium (K202531)Azer Scientific, Inc.2024-04-11
Lyric4 Hearing Aid (K232999)Sonova AG2024-04-11
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240021)Yue Kang Anhui Medical Products Co., Ltd.2024-04-08
Peleton Universal Single Use Power System and Attachments (K240071)Peleton Surgical2024-04-04
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (K240361)Hebei Titans Hongsen Medical Technology Co., Ltd.2024-04-04
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240080)Syntex Healthcare Products Co., Ltd.2024-04-02
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) (K233990)Shandong Xingyu Gloves Co., Ltd.2024-04-01
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, (K230895)Cefla S.C.2024-04-01
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K232079)Wrp Asia Pacific Sdn. Bhd.2024-03-28
ARX Liquid Amies Collection & Transport System (K222613)Arx Sciences, Inc.2024-03-27
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K234097)Ever Growth (Vietnam) Corporation Limited2024-03-27
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K231938)O&M Halyard, Inc.2024-03-22
N2 (K240754)Megagen Implant Co., Ltd.2024-03-21
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) (K232654)Nephron Nitrile, LLC2024-03-20
ARX Viral Transport Media Collection and Transport System (K231843)Arx Sciences, Inc.2024-03-19
Fiber Optic Brushless Electronic Micromotor, model: iM100 (K231864)Codent Technical Industry Co., Ltd.2024-03-11
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves (K231365)Anhui Intco Medical Products Co., Ltd.2024-03-01
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K240051)Lingshi Hongruida Health Protection Technology Co., Ltd.2024-02-29
Dental unit Model: Mare (K231845)Foshan Safety Medical Equipment Co., Ltd.2024-02-28
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)Eco Medi Glove Sdn. Bhd.2024-02-26
Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K233740)W.A. Rubbermate Co., Ltd.2024-02-13
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K240072)Luliang Hongruida Health Protection Technology Co., Ltd.2024-02-09
Access SHBG (K233480)Beckman Coulter, Inc.2024-02-08
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232764)Eco Medi Glove Sdn. Bhd.2024-02-07
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598)Anhui Intco Medical Products Co., Ltd.2024-01-26
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K233970)Nephron Nitrile, LLC2024-01-16
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K233520)Anhui Powerguard Technology Co., Ltd.2024-01-12
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim (K233405)Eco Medi Glove Sdn. Bhd.2023-12-28
KaiBiLi Extended ViralTrans (K231027)Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.2023-12-21
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (K232444)Grand Work Plastic Products Co., Ltd.2023-12-20
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) (K233182)Zibo Kaiyue Mould Technology Co., Ltd.2023-12-15
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Every clearance here is in the API, with alerts when new ones post.