| AlphaTriPart - Monopolar MIC Instruments (K261179) | Gimmi GmbH | 2026-07-22 |
| Volnewmer™ (K253504) | Classys, Inc. | 2026-07-13 |
| 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 |
| LUTRONIC GENIUS (K253484) | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| Irrigation Tubing Bipolar Cord Set (K251492) | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (K260636) | Stryker Sustainability Solutions | 2026-06-18 |
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| NEUROMARK System (NMK00301) (K261833) | Neurent Medical , Ltd. | 2026-06-16 |
| LAP-iX2N (K253165) | Sejong Medical Co., Ltd. | 2026-06-09 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656) | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| MILAN System (K253803) | Lumenis Be, Ltd. | 2026-06-02 |
| Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (K253918) | F Care Systems USA, LLC | 2026-06-02 |
| ENTire IRE System (K261202) | Entire Medical , Ltd. | 2026-05-29 |
| VIVA combo RF System (K252833) | Starmed Co., Ltd. | 2026-05-26 |
| LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) (K253134) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| RhinAer+ Stylus (K260522) | Aerin Medical, Inc. | 2026-05-18 |
| Ascblue (8010) (K253777) | Ascblue Corporation | 2026-04-10 |
| ARION ARC System (K253917) | Plasma Surgical, Inc. | 2026-04-10 |
| 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 |
| Prana System (K253405) | Prana Surgical | 2026-04-01 |
| FLOW FLEXTEND Wand (72290039) (K254122) | ArthroCare Corporation | 2026-03-30 |
| AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (K260255) | Aventix Medical, Inc. | 2026-03-27 |
| LYNX COBLATION Laryngeal Wand (72290254) (K253680) | ArthroCare Corporation | 2026-03-25 |
| BTL-785NEH (K253750) | BTL Industries, Inc. | 2026-03-17 |
| POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (K252487) | Gyrus Acmi, Inc. | 2026-03-02 |
| SP Electrocautery Device (SP20) (K260287) | Single Pass, Inc. | 2026-02-24 |
| CURIS II RF Generator (REF 360100-05) (K251813) | Sutter Medizintechnik GmbH | 2026-02-11 |
| Dermatrix Duo (K251836) | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |
| ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (K254290) | Shenzhen Peninsula Medical Group | 2026-01-30 |
| InbellaIgnite RF System (K251435) | Inbella Medical, Inc. | 2026-01-27 |
| Reusable 3 Button Fingerswitch Wand (K254220) | Soniquence, LLC | 2026-01-27 |
| Ignite RF System (K251254) | InMode , Ltd. | 2026-01-15 |
| ENTire IRE System (K251996) | Entire Medical , Ltd. | 2026-01-14 |
| Boston iFace (Boston iFace) (K251988) | Boston Aesthetics, Inc. | 2026-01-12 |
| MOVIVA® Hybrid Ablation Probe (K253915) | Erbe Elektromedizin GmbH | 2025-12-18 |
| F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (K252704) | F Care Systems USA, LLC | 2025-11-24 |
| TS-RF Generator (STS10) (K251566) | Starmed Co., Ltd. | 2025-11-17 |
| Venus Nova (FP-2001) (K252845) | Venus Concept, Inc. | 2025-11-06 |
| Voyant® Open Fusion Device (EB240/Open Fusion) (K252740) | Applied Medical Resources Corp. | 2025-11-04 |
| Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (K252412) | Applied Medical Resources Corporation | 2025-10-31 |
| PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (K250275) | Baylis Medical Technologies, Inc. | 2025-10-28 |
| ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (K250126) | Livsmed, Inc. | 2025-10-21 |
| Coolfase (K250852) | Asterasys Co., Ltd. | 2025-10-16 |
| InbellaMulti System (K252367) | Inbella Medical, Inc. | 2025-10-15 |
| Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) (K252150) | Olympus Medical Systems Corporation | 2025-10-07 |
| Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) (K250688) | Acotec Scientific Co., Ltd. | 2025-10-07 |
| E Blator (K251899) | New Deantronics Taiwan , Ltd. | 2025-10-01 |
| NEW DOUBLO 2.0 (K251334) | Hironic Co., Ltd. | 2025-09-29 |
| Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (K252043) | Olympus Winter & Ibe GmbH | 2025-09-23 |
| Legend X Platform (K252576) | Pollogen, Ltd. | 2025-09-12 |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K250483) | Stryker Instruments | 2025-09-09 |
| AGNES Ultra (K250217) | Agnes Medical Co., Ltd. | 2025-09-03 |
| Erbe ESU Model VIO® 3n with Accessories (K251108) | Erbe Elektromedizin GmbH | 2025-08-29 |
| Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (K252316) | Venclose, Inc. | 2025-08-19 |
| Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (K243713) | Agnes Medical Co., Ltd. | 2025-08-19 |
| HOTWIRE™ System RF Generator and Footswitch (optional accessory) (K252083) | Atraverse Medical, Inc. | 2025-08-12 |
| XERF (K251327) | Lutronic Corporation | 2025-08-11 |
| Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) (K252211) | Cnc Technologies | 2025-08-11 |
| InbellaMAX System (K252215) | Inbella Medical , Ltd. | 2025-07-25 |
| DENSITY; DENZA; DENSITY Noir (K250065) | Jeisys Medical Incorporated | 2025-07-08 |
| HybridAPC probe (K243120) | Erbe Elektromedizin GmbH | 2025-06-20 |
| Electrosurgical Pads (K251235) | Baisheng Medical Co., Ltd. | 2025-06-19 |
| EndyMed PRO MAX (K242996) | Endymed Medical, Ltd. | 2025-06-10 |
| DELPHI System (K242907) | CnS Medical Co., Ltd. | 2025-06-06 |
| gi2000 Electrosurgical Generator (K250657) | Cintron Medical Corporation | 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 |
| NEUROMARK System (NMK00301) (K250048) | Neurent Medical , Ltd. | 2025-05-29 |
| BLESSING System (K243176) | Cellah Medical Co., Ltd. | 2025-05-16 |
| Youmagic FLM System (YM5-U1) (K240857) | We Medical Technology (Wuxi) Co., Ltd. | 2025-05-15 |
| Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (K250400) | Vigeon Technology Co., Ltd. | 2025-05-09 |
| RFMagik Lite (K242469) | Agnes Medical Co., Ltd. | 2025-04-25 |
| Electro Lube NXT (K242773) | Steris | 2025-04-15 |
| OptaBlate Radiofrequency (RF) Generator System (K250327) | Stryker Instruments | 2025-04-15 |
| FiAPC plus probes (K243451) | Erbe Elektromedizin GmbH | 2025-03-21 |
| Sunny (K242241) | ShenB Co., Ltd. | 2025-03-19 |
| Vasoview Hemopro 3 Power Supply (K243918) | Maquet Cardiovascular, LLC | 2025-02-26 |
| Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (K241832) | Boston Aesthetics, Inc. | 2025-02-13 |
| InbellaBody System (K250200) | Inbella Medical, Inc. | 2025-02-11 |
| CROMA Electrosurgical Generator (PRD-EMR-050) (K242983) | Creo Medical, Ltd. | 2025-02-05 |
| Venclose digiRF Generator (VCRFG1) (K250068) | Venclose, Inc. | 2025-02-04 |
| Reverso Pro System (K243139) | Indiba S. A. U. | 2025-01-22 |
| JETT Medical II (K240311) | Compex, Spol, S.R.O. | 2025-01-22 |
| Oligio X (K243929) | Wontech Co., Ltd. | 2025-01-21 |
| The ETHICON™ Total Energy System (K243067) | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025-01-17 |
| Inbella RF System (K243737) | Inbella Medical, Inc. | 2025-01-03 |
| DUET-V (Model: ESK-3261DV) (K233118) | Eunsung Global Corp | 2025-01-03 |
| RM STAR EX with RMS Needle (K243097) | Bomtech Electronics Co., Ltd. | 2024-12-26 |
| Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) (K240975) | Beijing Taktvoll Technology Co., Ltd. | 2024-12-23 |
| Finiff System (K242688) | Skingrab Co., Ltd. | 2024-12-20 |
| Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (K242370) | Medline Industries, LP | 2024-12-19 |
| Radiofrequency Generator System, Cura RF Electrode (K240758) | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-12-11 |
| POTENZA (K231216) | Jeisys Medical, Inc. | 2024-12-10 |
| Aerin Console (K242630) | Aerin Medical, Inc. | 2024-12-10 |
| Cellinew (K240897) | VIOL Co., Ltd. | 2024-11-26 |
| Secret MAX Multi-platform RF System (K241157) | Ilooda Co,., Ltd. | 2024-11-21 |
| ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (K241138) | Livsmed, Inc. | 2024-11-15 |
| Superflow Prime Treatment System (ASP-1M) (K242286) | Guangzhou Aimira Innovation Technology Co, Ltd. | 2024-11-08 |
| Plasonic (Plasonic) (K241099) | Hironic Co., Ltd. | 2024-11-08 |
| POTENZA (K231287) | Jeisys Medical, Inc. | 2024-11-05 |