| Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (K260688) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-05-04 |
| Phototherapy System (DUV-COMBO) (K254234) | Choyang Medics Co., Ltd. | 2026-05-01 |
| Verifine Safety Lancets (K261045) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| YellowStar (K261094) | Asclepion Laser Technologies GmbH | 2026-04-29 |
| Cardinal Health™ Poly Reinforced Surgical Gown (K253243) | Cardinal Health 200, LLC | 2026-04-28 |
| Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) (K260982) | Applied Medical Resources Corporation | 2026-04-24 |
| NeuroBlate System (K260976) | Monteris Medical | 2026-04-23 |
| LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (K260150) | NOOANCE | 2026-04-22 |
| VANISH PRO (K253765) | Ddc Technologies, Inc. | 2026-04-22 |
| ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (K253230) | Erbe Elektromedizin GmbH | 2026-04-22 |
| IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) (K260518) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2026-04-21 |
| Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (K253003) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| Q-Switched Nd: YAG Laser System (Glamor Q) (K260153) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (K260129) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 |
| Diode Laser Therapy Systems (V19) (K260307) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
| Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (K253107) | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 |
| Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (K253657) | Covidien (Part of Medtronic) | 2026-04-10 |
| Ascblue (8010) (K253777) | Ascblue Corporation | 2026-04-10 |
| ARION ARC System (K253917) | Plasma Surgical, Inc. | 2026-04-10 |
| Artelon Convenience Kits (K260317) | International Life Sciences | 2026-04-09 |
| Picosecond Nd:YAG Laser Systems (Model: HS-298) (K260017) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) (K260466) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (K260397) | Hironic Co., Ltd. | 2026-04-06 |
| LSSA (NP-200) (K252495) | Newpong Co., Ltd. | 2026-04-03 |
| Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (K252198) | Medical Brands Laboratories B.V. | 2026-04-02 |
| SPECCHIO (K260647) | El.En S.P.A. | 2026-04-02 |
| Prana System (K253405) | Prana Surgical | 2026-04-01 |
| Nd: YAG Laser Therapy Systems (K260375) | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| Safety lancet (XXXVII) (K260191) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| FLOW FLEXTEND Wand (72290039) (K254122) | ArthroCare Corporation | 2026-03-30 |
| CO2 Laser System (K260257) | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (K260255) | Aventix Medical, Inc. | 2026-03-27 |
| STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (K253572) | ETHICON, Inc. | 2026-03-27 |
| LYNX COBLATION Laryngeal Wand (72290254) (K253680) | ArthroCare Corporation | 2026-03-25 |
| NanoKnife Generator (H78720300351US0) (K253198) | Angiodynamics | 2026-03-24 |
| HyperSuture All Green Extension Line (K254275) | Threadstone, LLC | 2026-03-23 |
| LED Light Therapy Masks (LumiLips FAC07NA) (K260202) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 |
| HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (K251967) | O&M Halyard, Inc. | 2026-03-18 |
| BTL-785NEH (K253750) | BTL Industries, Inc. | 2026-03-17 |
| Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) (K252971) | C.R. Bard, Inc. | 2026-03-17 |
| LASER THERMAL THERAPY KIT (K260632) | Elesta S.P.A | 2026-03-17 |
| Ulike Reglow Light Therapy Device (UM10) (K260511) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 |
| LED Light Therapy Mask (Models: T2, RLD10) (K254079) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 |
| Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (K253391) | Medtronic Navigation, Inc. | 2026-03-13 |
| Apollo Quattro (APQ-10M) (K253261) | Weero Co., Ltd. | 2026-03-13 |
| Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (K260147) | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 |
| Genadyne ASTRA NPWT (K253429) | Genadyne Biotechnologies, Inc. | 2026-03-12 |
| MEDPOR Customized Implant Kit (K254233) | Stryker Leibinger GmbH & Co KG | 2026-03-12 |
| Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) (K254047) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-03-11 |
| Picasso Pro Diode Laser (002-00460) (K254197) | CAO Group, Inc. | 2026-03-11 |
| Gemini NOVA 810+980 Soft Tissue Laser (K260765) | Azena Medical, LLC | 2026-03-10 |
| NeoSculpt Plus (K252888) | S&M Medical Co., Ltd. | 2026-03-09 |
| Medicell Mycosis Laser (MCML24004) (K253960) | Medicell Healthcare Co.,LTD | 2026-03-09 |
| Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (K253951) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |
| Klär Lite (RCW-KL1000) (K253871) | Radcliffe Watts, LLC | 2026-03-04 |
| LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (K253878) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-03-04 |
| CO2 Laser Treatment Machine (CFR3M1) (K253920) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 |
| Surgical Face Mask (Ear mount) (K252534) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 |
| LED Therapy Light (COB1400, HP1800PRO) (K253874) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 |
| POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (K252487) | Gyrus Acmi, Inc. | 2026-03-02 |
| Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) (K253771) | Nanjing Devin Medical Technology Co., Ltd. | 2026-03-02 |
| Microwave Ablation Device (K252632) | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 |
| Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) (K253829) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 |
| Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (K253828) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 |
| Copioumed AAMI 3 Surgical Gown (K251860) | Copioumed International, Inc. | 2026-02-26 |
| CAPRI (K254271) | ORO Co., Ltd. | 2026-02-26 |
| Swift Ray 1 (K251678) | Swift Medical, Inc. | 2026-02-24 |
| Diode Laser Therapy Systems (WLA-02) (K252599) | Wingderm Electro-Optics , Ltd. | 2026-02-24 |
| SP Electrocautery Device (SP20) (K260287) | Single Pass, Inc. | 2026-02-24 |
| XSense Cryoablation System with CryoProbes (K260377) | IceCure Medical , Ltd. | 2026-02-24 |
| IPL Hair Removal Device (Models: T31A, T32A) (K253666) | Shenzhen Mlay Intelligent Technology Co., Ltd. | 2026-02-23 |
| Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (K253531) | Applied Medical Resources Corporation | 2026-02-23 |
| Safety Heel Lancet (K253605) | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (K253683) | Foreo, Inc. | 2026-02-20 |
| Meniscus Versaflex (K254188) | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| SkinStylus SteriLock MicroSystem (MP1209SL) (K253002) | Esthetic Medical, Inc. | 2026-02-19 |
| Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (K253398) | Efofex, Inc. | 2026-02-19 |
| BTL-754FF (K252561) | BTL Industries, Inc. | 2026-02-18 |
| CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928) | Medinice S.A. | 2026-02-13 |
| Contour Light (CL-100) (K243854) | Contour Research, LLC | 2026-02-13 |
| Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (K252490) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (K254007) | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 |
| CURIS II RF Generator (REF 360100-05) (K251813) | Sutter Medizintechnik GmbH | 2026-02-11 |
| MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852) | ETHICON, Inc. | 2026-02-06 |
| Dermatrix Duo (K251836) | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |
| Amferia Wound Dressing (DEN250006) | Amferia AB | 2026-02-06 |
| Henan Yadu Level 4 Surgical Gowns (Reinforced) (K252301) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| 808nm semiconductor laser hair removal machine (K252048) | Xi'An Taibo Electronic Technology Co., Ltd. | 2026-02-03 |
| Explant Express (K252438) | Applied Medical Technology, Inc. | 2026-02-03 |
| ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (K254290) | Shenzhen Peninsula Medical Group | 2026-01-30 |
| Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (K253833) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-01-30 |
| Boston PICO (Boston PICO) (K251981) | Boston Aesthetics, Inc. | 2026-01-30 |
| HIGHERDOSE Body Sculptor (Model: GS-03) (K252603) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 |
| InbellaIgnite RF System (K251435) | Inbella Medical, Inc. | 2026-01-27 |
| Reusable 3 Button Fingerswitch Wand (K254220) | Soniquence, LLC | 2026-01-27 |
| Holmium Laser Therapeutic Apparatus (HZ-40) (K253633) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-01-24 |
| Vydence Family of Lasers (K252753) | Vydence Medical Industria E Commercio Ltda | 2026-01-24 |
| LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (K253712) | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 |
| HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (K253761) | Devicor Medical Products, Inc. | 2026-01-23 |
| Boston Pico755 (K252369) | Boston Aesthetics, Inc. | 2026-01-21 |