| Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) (K251544) | Lakong Medical Devices Co., Ltd. | 2026-08-07 |
| Manual Wheelchair (H008, PCK7) (K261571) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 |
| Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K260558) | Hartalega NGC Sdn. Bhd. | 2026-07-28 |
| GEN 4 JOY Wheelchair (K252370) | Free Wheelchair Mission | 2026-07-24 |
| PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves (K262014) | O&M Halyard, Inc. | 2026-07-21 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue (K254285) | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| 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 (K252117) | Sw Technologies, Inc. | 2026-06-24 |
| Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) (K261076) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| Manual Wheelchair (MS01);Manual Wheelchair (MA01) (K261075) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| Powder Free Nitrile Examination Gloves Non-Sterile Black (K253824) | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| 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) (K260867) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| ICON 35; ICON 45; ICON 60; ICON 30FAF (K260849) | Rehasense USA, Inc. | 2026-06-11 |
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| 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 (K260703) | S&S Glove Corporation | 2026-06-03 |
| Nitrile Disposable Examination Gloves (K260806) | Vista Industries,, LLC | 2026-06-03 |
| Manual Wheelchair (LW01108) (K260642) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 |
| Helio Kids; Apex P (K260295) | Motion Composites | 2026-05-28 |
| BD BACTEC FXI Culture System (K260213) | BD Diagnostic Systems | 2026-05-28 |
| Sterile Latex Powder Free Surgical Gloves (K253060) | Protect Gloves Company Limited | 2026-05-22 |
| Manual Wheelchair (DY01903(2)) (K254141) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 |
| Derma-2 (K253911) | Neko Health AB | 2026-05-20 |
| AllTest Strep A Rapid Test (K260342) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 |
| Manual Wheelchair (7101L, 7102LHD) (K260121) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 |
| IDS-iSYS Total Testosterone (K252728) | Immunodiagnostic Systems Limited | 2026-04-15 |
| Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (K260860) | Basic Medical Technology, Inc. | 2026-04-07 |
| SMART M-CELL Bone Marrow Concentration System (K250518) | Miracell Co., Ltd. | 2026-04-02 |
| SMART M-CELL PRP Concentration System (K250516) | Miracell Co., Ltd. | 2026-04-02 |
| Medical Imaging Calibration Feature (MICF) (K253582) | Apple, Inc. | 2026-04-01 |
| 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)) (K260319) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 |
| Clungene RSV Antigen Rapid Test (K253318) | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| Motor Handpiece and Control Unit (SDI10) (K251407) | Saeshin Precision Co., Ltd. | 2026-01-30 |
| Manual Wheelchair (W50) (K253632) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 |
| Syntex Exam Gloves (K253160) | Basic Medical Technology, Inc. | 2026-01-23 |
| Sana Device (DEN250005) | Sana Health | 2026-01-16 |
| Cardinal Health Nitrile Examination Gloves Extended Cuff (K252313) | Cardinalhealth | 2026-01-14 |
| 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 (K252549) | Kossan International Sdn Bhd | 2026-01-13 |
| EmpowerRide NAVIGATOR (K251886) | Empower Ride, LLC | 2026-01-12 |
| High speed air turbine handpiece (K251389) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| 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) (K251388) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| Star E900 Electric System (K251701) | Dentalez, Inc., Stardental Division | 2026-01-12 |
| Lipids (K251091) | Truvian Health | 2025-12-30 |
| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| Manual Wheelchair (W45) (K252825) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| Manual Wheelchair (W47) (K252828) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697) | ACON Laboratories, Inc. | 2025-11-26 |
| Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (K242976) | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 |
| Manual Wheelchair (HM305-Air1, HM305-Air2) (K252687) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 |
| 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 (K251141) | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| Flexx Junior (FLX-J00, FLX-J50) (K250576) | Karma Mobility Co, Ltd. | 2025-11-04 |
| Midmark Dental Delivery System (K251626) | Midmark Corporation | 2025-11-03 |
| AllTest Urinary Tract Infection Test (K252607) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| Disposable Vinyl Examination Gloves (K252467) | Viet Phu Trade and Import Export Co., Ltd. | 2025-10-27 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (K250861) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| Modius Lean (DEN240076) | Neurovalens Limited | 2025-10-17 |
| Program insite® Powder-Free, Disposable Nitrile Exam Gloves (K252075) | Program Insite, LLC | 2025-10-17 |
| Alpha Endo Handpiece (Alpha Endo) (K252223) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 |
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| Manual Wheelchair (SYIV100A008) (K252517) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 |
| Babio® Virus Transport Kit (Non-inactivating) (K250205) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 |
| InnerView System (K251597) | Perimetrics, Inc. | 2025-09-18 |
| ACCUJECT Injector Set 2.1-1P (LP604590) (K252540) | Medicel AG | 2025-09-16 |
| Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869) | Premium Plus (Dongguan) Limited | 2025-09-15 |
| Powder-Free Vinyl Exam Gloves, clear (K252505) | Basic Medical Technology, Inc. | 2025-08-28 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716) | Basic Medical Technology, Inc. | 2025-08-27 |
| Motor and Apex Module (MaAM) (K251811) | Dentsply Sirona, Inc. | 2025-08-25 |
| EnDrive (EnDriveUS) (K243692) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 |
| 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 (K252244) | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (K250313) | Harps Europe Manufacturing GmbH | 2025-08-19 |
| 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 (K243604) | O&M Halyard, Inc. | 2025-08-18 |
| MycoMEIA Aspergillus Assay (K243496) | Pearl Diagnostics, Inc. | 2025-08-01 |
| 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 (K251319) | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| LymphaTech Mobile 3D Measuring Tool (K251255) | Lymphatech, Inc. | 2025-07-22 |
| ELEC ENGINE (Model: ISE-170L) (K231562) | Micro-Nx Co., Ltd. | 2025-07-18 |
| K5 Cart, K5 Mount, K5 Swing (K251491) | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 |
| TurbAlign (K243655) | Spirair, Inc. | 2025-07-11 |
| Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (K250193) | Basic Medical Technology, Inc. | 2025-07-09 |
| Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (K250342) | Encompass Industries Sdn. Bhd. | 2025-07-08 |
| Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) (K250496) | Zibo Shengkun Chemical Industry Co., Ltd. | 2025-07-07 |
| Integral Dental Unit (K243130) | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 |
| Digital Prism Correction Feature (DPCF) (K250143) | Apple, Inc. | 2025-06-23 |
| Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (K243172) | O&M Halyard, Inc. | 2025-06-18 |
| Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K243133) | Kl-Kepong Rubber Products Sdn. Bhd. | 2025-06-17 |
| Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (K243694) | Mah Sing Healthcare Sdn. Bhd. | 2025-06-06 |
| GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (K243796) | Glove One, LLC | 2025-06-03 |
| Disposable Prophy Angle (K240950) | Pacific Care Limited | 2025-05-28 |
| Integral Dental Units (K242611) | Mipont Medical Equipment Co., Ltd. | 2025-05-27 |
| 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 (K250630) | Basic Medical Technology, Inc. | 2025-05-22 |
| Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (K250069) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 |
| Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (K242514) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 |
| Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (K250944) | Gmp Medicare Sdn. Bhd. | 2025-04-23 |
| Dental Implant Unit (K242646) | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025-04-11 |
| AllTest Viral Transport Medium (K242576) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| UASure II Blood Uric Acid Monitoring System (K242209) | Apex BioTechnology Corp. | 2025-04-04 |
| Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (K250578) | Careglove Global Sdn. Bhd. | 2025-04-01 |
| ChecQ (AC100) (K241065) | Dentis Co., Ltd. | 2025-03-21 |
| SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (K250502) | Safesource Direct, LLC | 2025-03-19 |
| Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242533) | Better Care Plastic Technology Co., Ltd. | 2025-03-18 |
| Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (K241374) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 |
| Synea Fusion Handpieces (Intensiv & Profin) (K242179) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 |
| Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (K243959) | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 |