| IPL Treatment Device (MDSQMC-01) (K243123) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| Pastelle (K250165) | Wontech Co., Ltd. | 2025-07-03 |
| Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (K251054) | Teleflex Medical | 2025-07-03 |
| SurgiLight 1470 Diode Laser System (Model:Halo) (K251049) | Micro-Energy Medical Technology Co., Ltd. | 2025-07-02 |
| CS-Pro MED (K250779) | Curative Sound Therapeutics | 2025-07-02 |
| AuroLase® System (K243701) | Nanospectra Biosciences, Inc. | 2025-07-02 |
| Fiber Laser Treatment Systems (HS-232,HS-233) (K251031) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 |
| droplet® personal lancets (K250016) | Htl-Strefa S.A | 2025-07-01 |
| Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (K251000) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2025-06-30 |
| Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187) | Cork Medical | 2025-06-27 |
| Diode laser device (RF3120-BI) (K251329) | Risu Medical Technology Co., Ltd. | 2025-06-27 |
| Optimas MAX System (K251632) | InMode , Ltd. | 2025-06-26 |
| safety lancet (K251694) | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (K250966) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-25 |
| LED Facial Mask (K243978) | Shenzhen Sunsred Technology Co.,Ltd | 2025-06-20 |
| HybridAPC probe (K243120) | Erbe Elektromedizin GmbH | 2025-06-20 |
| LED LIGHT MASK (A093) (K250880) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | 2025-06-20 |
| Restrata Soft Tissue Reinforcement (STR) (K251224) | Acera Surgical, Inc. | 2025-06-20 |
| Electrosurgical Pads (K251235) | Baisheng Medical Co., Ltd. | 2025-06-19 |
| Procedure mask/Surgical mask/Face mask (K250082) | Winner Medical Co., Ltd. | 2025-06-18 |
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (K243036) | Bestway Plastic and Metal Products , Ltd. | 2025-06-15 |
| MV Flow Aspiration Pump (MVFLOWPMP01) (K243638) | Microvention | 2025-06-13 |
| Q-Switched Nd:YAG Laser (SHE-LSP101-1) (K250936) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-06-12 |
| Deka Bluebeam (K243683) | El.En S.P.A. | 2025-06-12 |
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Fractional CO2 Laser Machine (K250782) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-06-12 |
| Self-Forming Magnet (Flexagon) (K243482) | GI Windows, Inc. | 2025-06-11 |
| EndyMed PRO MAX (K242996) | Endymed Medical, Ltd. | 2025-06-10 |
| Dental Barrier and Sleeves (K250735) | Fomed Industries, Inc. | 2025-06-10 |
| CO2 Laser Machine (Lume) (K250465) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-06-09 |
| LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (K250830) | Shenzhen Sungrow Led Technology Co., Ltd. | 2025-06-09 |
| Magnetic Surgical System (K250746) | Levita Magnetics International Corp | 2025-06-07 |
| Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (K240983) | Quanta System Spa | 2025-06-06 |
| Light Therapy System (M500, L6) (K251042) | Guangzhou Ahead Intelligent Technology Co., Ltd. | 2025-06-06 |
| Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) (K251450) | Shenzhen Desida Technology Co., Ltd. | 2025-06-06 |
| TYBR Collagen Gel (K250109) | Tybr Health | 2025-06-06 |
| Anovo Surgical System (6Ne) (K250591) | Momentis Surgical , Ltd. | 2025-06-06 |
| DELPHI System (K242907) | CnS Medical Co., Ltd. | 2025-06-06 |
| Nd: YAG Laser Therapy System (QN-1) (K250722) | Hebei JT Medical Co., Ltd. | 2025-06-06 |
| Tendon Protect (50242) (K243843) | Kerecis Limited | 2025-06-04 |
| gi2000 Electrosurgical Generator (K250657) | Cintron Medical Corporation | 2025-06-03 |
| Endoform Reconstructive Template - PLGA (K250598) | Aroa Biosurgery , Ltd. | 2025-06-03 |
| Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (K251238) | Maquet Cardiovascular, LLC | 2025-05-30 |
| MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) (K250195) | Matelaser, Inc. | 2025-05-30 |
| Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (K243010) | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 |
| TekBrace Solo Soft Tissue Reinforcement Device (K251063) | Theramicro | 2025-05-30 |
| KALA Red Light Face Mask (KALA-01) (K250581) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-30 |
| ViVi® Toga Premium (K243522) | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307) | Medtronic Navigation | 2025-05-29 |
| Dental Barrier and Sleeves (K250606) | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025-05-29 |
| SuturePatch Tissue Reinforcement (K243480) | Arthrex, Inc. | 2025-05-29 |
| NEUROMARK System (NMK00301) (K250048) | Neurent Medical , Ltd. | 2025-05-29 |
| Zionic Pro Max (Radiofrequency) (K243716) | Termosalud S.L. | 2025-05-28 |
| Dexter L6 System (K250435) | Distalmotion SA | 2025-05-27 |
| IPL400 (K250384) | El Global Trade, Ltd. | 2025-05-23 |
| Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (K250938) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-05-23 |
| Solawave 2-in-1 Skincare Mini (Model: 61043) (K250532) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-22 |
| Skin Clinic Freeze Point for Warts and Skin Tags (K251493) | Cryoconcepts LP | 2025-05-22 |
| The Alma Hybrid Laser System (K251230) | Alma Lasers, Inc. | 2025-05-21 |
| 3DMatrix DynaFlex (DynaFlex) (K243302) | Printbio, Inc. | 2025-05-21 |
| Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (K244033) | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 |
| BLESSING System (K243176) | Cellah Medical Co., Ltd. | 2025-05-16 |
| NPseal (K251156) | Guard Medical, Inc. | 2025-05-15 |
| Youmagic FLM System (YM5-U1) (K240857) | We Medical Technology (Wuxi) Co., Ltd. | 2025-05-15 |
| MICROLET®NEXT 2 Lancing Device (K250813) | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 |
| Medical Picosecond ND: YAG Laser System (PZ-6) (K250041) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-14 |
| ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) (K250835) | Ethicon Endo-Surgery, LLC | 2025-05-14 |
| Veincare (K251288) | Wontech Co., Ltd. | 2025-05-14 |
| Ulthera System (UC-1 Control Unit PRIME Model 2.1) (K250418) | Ulthera, Inc. | 2025-05-13 |
| AYON Body Contouring System (AYON SYSTEM) (K244050) | Apyx Medical Corporation | 2025-05-12 |
| Medical Diode Laser Hair Removal System (MNLT-D1) (K250431) | Shandong Moonlight Electronics Tech Co., Ltd. | 2025-05-12 |
| Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (K250400) | Vigeon Technology Co., Ltd. | 2025-05-09 |
| Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (K243764) | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 |
| Cary (K251111) | Excitus AS | 2025-05-07 |
| IPL Hair Removal Device (KCA511/KCA516/KCA522) (K250253) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-05-06 |
| Alma Veil (K251094) | Wontech Co., Ltd. | 2025-05-06 |
| IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) (K243017) | Foshan Newface Electronic Technology Co., Ltd. | 2025-05-06 |
| Dream Medi Sterile Surgical Gown (SurgicalGownUL) (K242937) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251056) | Momentis Surgical , Ltd. | 2025-05-02 |
| Wrinkle Treatment Device (JM1, JM2B) (K244020) | Shenzhen Qianyu Technology Co., Ltd. | 2025-05-01 |
| Suture-TOOL System (K250977) | Suturion AB | 2025-04-28 |
| Diode laser hair removal machine (QDTM-02) (K242951) | Beijing Nubway S&T Co., Ltd. | 2025-04-28 |
| AIRO Suction Unit (AIRO-01) (K251101) | Cro, LLC | 2025-04-26 |
| RFMagik Lite (K242469) | Agnes Medical Co., Ltd. | 2025-04-25 |
| PAL 7020 Console (K244026) | Microaire Surgical Instruments, LLC | 2025-04-25 |
| Diode laser system (Night Universe; Predator) (K250206) | Ivylaser (Beijing) Technology Co.,Ltd | 2025-04-24 |
| CO2 Laser System (CO2 Laser SST-L23) (K250183) | Zhuozhou Summer Star Technologies Co., Ltd. | 2025-04-24 |
| Electric Nasal Aspirator (BC026, BC025, BC023) (K250697) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 |
| Parietene™ Macroporous Mesh (PPM5050 ) (K250869) | Sofradim Production | 2025-04-23 |
| handLITE (TN19S) (K250224) | iSMART Developments, Ltd. | 2025-04-18 |
| FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 |
| HEBE (NP0000763) (K241733) | Novasonix Technology S.L. | 2025-04-16 |
| Stellar M22 (K250809) | Lumenis Be, Ltd. | 2025-04-16 |
| Préime DermaFacial Collagen+ (K243055) | EMA Aesthetics , Ltd. | 2025-04-15 |
| Electro Lube NXT (K242773) | Steris | 2025-04-15 |
| Skin Clinic Nitro Clear Wart Remover (K242932) | Cryoconcepts LP | 2025-04-15 |
| OptaBlate Radiofrequency (RF) Generator System (K250327) | Stryker Instruments | 2025-04-15 |
| AVAVA™ Skin Treatment System (K250402) | AVAVA, Inc. | 2025-04-14 |
| Alma Harmony (K243044) | Alma Lasers, Inc. | 2025-04-11 |