| Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (K261028) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 |
| LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (K261601) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 |
| LED Light Therapy Masks (PE748, PE749, PE756) (K261496) | Duplex International Trading Limited | 2026-08-04 |
| LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) (K261851) | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 |
| PuraStat GI (K261503) | 3-D Matrix, Inc. | 2026-08-03 |
| LightStim for Wrinkles (1984); LightStim for Acne (2038) (K261482) | Led Intellectual Properties, LLC | 2026-07-31 |
| 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 |
| 5 Wavelength LED Facemask (TN2508) (K260598) | iSMART Developments, Ltd. | 2026-07-24 |
| SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K261221) | Olympus Surgical Technologies America | 2026-07-24 |
| Lancet (K262211) | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 |
| Anovo Surgical System (6Ne) (K260804) | Momentis Surgical , Ltd. | 2026-07-22 |
| AlphaTriPart - Monopolar MIC Instruments (K261179) | Gimmi GmbH | 2026-07-22 |
| Medical Thulium Fiber Laser Systems (UroFiber 150Q) (K261738) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 |
| OTTAVA™ Robotic Surgical System (DEN250068) | Auris Health, Inc., part of Johnson & Johnson MedTech | 2026-07-21 |
| Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (K254231) | Taiwan Surgical Corporation | 2026-07-20 |
| Diode laser hair removal machine (QDTM-04) (K261693) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 |
| Skin Air Cooling System (QALF-01) (K261674) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 |
| XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) (K261407) | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 |
| Volnewmer™ (K253504) | Classys, Inc. | 2026-07-13 |
| NYES Tuff Cuff L3 Disposable Gowns (K261949) | New York Embroidery Studio | 2026-07-10 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| Capenergy C Equipments RF C200 and C400 Drakarian (K253480) | Capenergy Medical S.L. | 2026-07-10 |
| HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (K260723) | Procept Biorobotics | 2026-07-09 |
| Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (K261988) | Teleflex Medical, LLC | 2026-07-09 |
| Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) (K260122) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 |
| Chromix (K261473) | Termosalud S.L. | 2026-07-01 |
| THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (K254056) | Olympus Medical Systems Corp. | 2026-07-01 |
| EasyWhip Family (K261021) | Winter Innovations, Inc. | 2026-07-01 |
| Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (K261068) | Serpex Medical | 2026-06-30 |
| LUTRONIC GENIUS (K253484) | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (K261052) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 |
| Irrigation Tubing Bipolar Cord Set (K251492) | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (K254232) | Edwards Lifesciences | 2026-06-26 |
| Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (K253394) | ETHICON, Inc. | 2026-06-25 |
| ConvaVAC™ Negative Pressure Wound Therapy System (K253263) | Convatec Limited, Gdc Building | 2026-06-24 |
| CURASYS 2 (EMDN0003) (K253199) | CG Bio Co., Ltd. | 2026-06-23 |
| AQUABEAM Robotic System (K253211) | Procept Biorobotics | 2026-06-23 |
| LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (K260946) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 |
| Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) (K261701) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 |
| Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (K260636) | Stryker Sustainability Solutions | 2026-06-18 |
| PICOSURE WORKSTATION (K261570) | Cynosure, LLC | 2026-06-17 |
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| NEUROMARK System (NMK00301) (K261833) | Neurent Medical , Ltd. | 2026-06-16 |
| LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (K254025) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 |
| Disposable Blood Lancet (Soft) (K261634) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 |
| Barbed PDO Suture (K252171) | Sutura Medical Technology, Inc. | 2026-06-12 |
| Intense Pulsed Light Therapy Device (K261204) | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 |
| Dexter L6 System (K260653) | Distalmotion SA | 2026-06-11 |
| TekBrace Solo Soft Tissue Reinforcement Device (K261621) | Theramicro | 2026-06-09 |
| LAP-iX2N (K253165) | Sejong Medical Co., Ltd. | 2026-06-09 |
| ERBECRYO 2 Cryosurgical Unit and Accessories (K261806) | Erbe Elektromedizin GmbH | 2026-06-09 |
| Lipocosm Harmonic System (K251944) | Lipocosm, LLC | 2026-06-08 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656) | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| LumiGlam Laser System (SHE-LSP601-3) (K260690) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575) | New York Embroidery Studio (NYES) | 2026-06-04 |
| GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (K253102) | Gt Metabolic Solutions, Inc. | 2026-06-04 |
| CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (K260715) | The Beauty Tech Group, Ltd. | 2026-06-03 |
| Tissue Approximation System (K261484) | Tas Medical, Inc. | 2026-06-03 |
| Hemospray Endoscopic Hemostat (HEMO-[X]) (K253302) | Wilson-Cook Medical, Inc. | 2026-06-02 |
| MILAN System (K253803) | Lumenis Be, Ltd. | 2026-06-02 |
| Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (K253918) | F Care Systems USA, LLC | 2026-06-02 |
| VisionAir Enhanced Stock Stent (K261541) | VisionAir Solutions | 2026-06-01 |
| LASEmaR 1500 (K260489) | Eufoton S.R.L. | 2026-05-29 |
| LUNE PureHygiene (K260138) | Enamel Pure | 2026-05-29 |
| ENTire IRE System (K261202) | Entire Medical , Ltd. | 2026-05-29 |
| Trexon™ Monofilament Synthetic Absorbable Suture (K253530) | Medtronic | 2026-05-28 |
| RENASYS EDGE (66803126) (K260646) | Smith & Nephew Medical, Ltd. | 2026-05-27 |
| Momcozy Nasal Aspirator (BN007) (K253629) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 |
| VIVA combo RF System (K252833) | Starmed Co., Ltd. | 2026-05-26 |
| ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917) | Genesee Biomedical, Inc. | 2026-05-22 |
| Sterile Latex Powder Free Surgical Gloves (K253060) | Protect Gloves Company Limited | 2026-05-22 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (K261325) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-21 |
| Nisus NPWT Canister 500-mL (CPC-500) (K261291) | Cork Medical | 2026-05-21 |
| Boston 2910 (Boston 2910) (K253245) | Boston Aesthetics, Inc. | 2026-05-21 |
| Ulthera® System (K260618) | Ulthera, Inc. | 2026-05-21 |
| DeepView AI® System (DEN250028) | Spectralmd, Inc. | 2026-05-21 |
| ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956) | Sofradim Production | 2026-05-21 |
| IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) (K260594) | Shenzhen Xiazhifeng Electronic Co., Ltd. | 2026-05-20 |
| LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) (K253134) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) (K253309) | Shenzhen Soga Technology Co., Ltd. | 2026-05-19 |
| STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (K252047) | ETHICON, Inc. | 2026-05-18 |
| RhinAer+ Stylus (K260522) | Aerin Medical, Inc. | 2026-05-18 |
| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) (K260134) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 |
| Suction Pump (SU-90) (K260892) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 |
| Automatic Micro Needle System (CODE-X) (K252591) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| myLEDmask 2 (MJ-144) (K260415) | Light Tree Ventures Europe B.V. | 2026-05-12 |
| BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (K260473) | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 |
| PICO SHINING (PICO-K; PICOFY) (K261214) | Speclipse, Inc. | 2026-05-11 |
| ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) (K260196) | Ethicon Endo-Surgery, LLC | 2026-05-11 |
| Protable Phlegm Suction Unit (JMA D01) (K250964) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026-05-11 |
| AYON Body Contouring System™ (AYON SYSTEM) (K253396) | Apyx Medical Corporation | 2026-05-08 |
| Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (K253826) | Galvanize Therapeutics, Inc. | 2026-05-07 |
| CO2 Laser Machine (Monica-I,Monica-II) (K260974) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |
| Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) (K260742) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-05 |
| Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (K253251) | Leaseir Technologies, Slu | 2026-05-04 |
| Wound Geni NPWT System (K254019) | Bechtel Medical, Inc. | 2026-05-04 |
| Q-Switched Nd: YAG Laser Systems (K260256) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |