| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (K242151) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-04-08 |
| Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) (K243722) | Selio Medical Limited | 2025-04-08 |
| NPseal (K250708) | Guard Medical, Inc. | 2025-04-08 |
| E-PEN (E-PEN) (K243143) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| BioBrace ® RC Delivery System (K250395) | Conmed Corporation | 2025-04-07 |
| LED Therapy Mask (MN1, M226) (K242385) | Shenzhen Borria Technology Co., Ltd. | 2025-04-07 |
| Ultraviolet Phototherapy Device (K250425) | APK Technology Co., Ltd. | 2025-04-07 |
| Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (K250656) | Wuhan Pioon Technology Co., Ltd. | 2025-04-04 |
| LED Light Therapy Mask (RT01) (K242068) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 2025-04-04 |
| AdvaTx (K250189) | Advalight Aps | 2025-04-01 |
| Medical Diode Laser Systems (THEIA808) (K250018) | Gigaalaser Company , Ltd. | 2025-04-01 |
| Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (K250663) | Taewoong Medical Co., Ltd. | 2025-03-31 |
| HyperSuture White/Green Extension Line (K242201) | Threadstone, LLC | 2025-03-27 |
| SnapshotGLO (KB100) (K242669) | Kent Imaging, Inc. | 2025-03-26 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (K250194) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-03-26 |
| LMNT O2 (K250125) | Xplr , Ltd. | 2025-03-24 |
| UltraCor™ Twirl™ Breast Tissue Marker (K243642) | Bard Peripheral Vascular, Inc. | 2025-03-24 |
| FiAPC plus probes (K243451) | Erbe Elektromedizin GmbH | 2025-03-21 |
| Medical Laser System Incanto / Evoline Platinum /Evoline (K243630) | Solar LS Cjsc | 2025-03-21 |
| Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (K241791) | Gigaalaser Company , Ltd. | 2025-03-19 |
| IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (K250131) | Mustech Electronics Co., Limited | 2025-03-19 |
| 1NEED Pro (K243472) | Campomats S.R.L. | 2025-03-19 |
| IPL Hair Removal Device (BE965A, BE965B, BE965C) (K250171) | Shenzhen Yang WO Electronic Co., Ltd. | 2025-03-19 |
| Sunny (K242241) | ShenB Co., Ltd. | 2025-03-19 |
| Aglaia LED Beauty Device (BP-D2309) (K250413) | Shenzhen Perfect Idea Technology Limited | 2025-03-18 |
| QuikClot Control+ Hemostatic Device (K243553) | Teleflex Medical | 2025-03-18 |
| neoLaser Laser Surgery Fibers (K250113) | G.N.S Neolaser , Ltd. | 2025-03-13 |
| 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (K244022) | Boston Aesthetics, Inc. | 2025-03-13 |
| CryoFreeze Wart and Skin Tag Remover (K243487) | Cryosurgery, Inc. | 2025-03-13 |
| Photon Therapy Apparatus (BL-10) (K243993) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-03-13 |
| PICOALEX (K243957) | Wontech Co., Ltd. | 2025-03-12 |
| Wound Treatment System (VHT-200) (K250188) | Vaporox, Inc. | 2025-03-10 |
| NOABLE LASER (K242207) | Daeju Meditech Engineering Co., Ltd. | 2025-03-07 |
| ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (K241799) | Atmos Medizintechnik GmbH & Co. KG | 2025-03-07 |
| XCELLARISPRO TWIST microneedling device (K241790) | Dermaroller GmbH | 2025-03-06 |
| EnergyLounger (TY-01) (K241947) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-03-03 |
| Q Switched Nd:YAG Laser machine (QNHF-01) (K242943) | Beijing Nubway S&T Co., Ltd. | 2025-03-03 |
| MagDI System (MAG-02, DS-01) (K243359) | Gt Metabolic Solutions, Inc. | 2025-02-28 |
| XOD Diathermia Radiofrequency Device (K242175) | Xod, Inc. | 2025-02-27 |
| Rotium (K250021) | Nanofiber Solutions, LLC | 2025-02-27 |
| Medline Level 4 Surgical Gown with Breathable Sleeves (K242844) | Medline Industries, LP | 2025-02-26 |
| Vasoview Hemopro 3 Power Supply (K243918) | Maquet Cardiovascular, LLC | 2025-02-26 |
| Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (K244031) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| DEKA LOTUS (K250281) | El.En S.P.A. | 2025-02-26 |
| Heel Incision Safety Lancet (SteriHeel 2) (K244036) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) (K243276) | Ethicon Endo-Surgery, LLC | 2025-02-25 |
| Ulthera® System (K243035) | Ulthera, Inc. | 2025-02-24 |
| LYMA Laser PRO (K243330) | Lyma Life , Ltd. | 2025-02-21 |
| Medical diode laser systems (CHARISMA, REGAL) (K234004) | Reveal Lasers , Ltd. | 2025-02-20 |
| Phasix ST Umbilical Hernia Patch (K243241) | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
| Single Use CO2 Laser Fiber (HAF005001) (K243588) | Quanta System Spa | 2025-02-19 |
| RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (K243576) | Smith & Nephew Medical, Ltd. | 2025-02-18 |
| Pastelle Pro (K241527) | Wontech Co., Ltd. | 2025-02-14 |
| WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (K241643) | Wontech Co., Ltd. | 2025-02-14 |
| CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (K242593) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-02-14 |
| 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 |
| Philips Lumea IPL (K243453) | Philips Consumer Lifestyle B.V. | 2025-02-10 |
| Symani Surgical System (K242368) | Medical Microinstruments, Inc. | 2025-02-07 |
| HELIOS 785 Pico (1754V2) (K243780) | Laseroptek Co., Ltd. | 2025-02-07 |
| 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (K242977) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 |
| Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (K243465) | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2025-02-06 |
| CROMA Electrosurgical Generator (PRD-EMR-050) (K242983) | Creo Medical, Ltd. | 2025-02-05 |
| LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (K243555) | Shenzhen Eyco Technology Co., Ltd. | 2025-02-05 |
| Venclose digiRF Generator (VCRFG1) (K250068) | Venclose, Inc. | 2025-02-04 |
| Geon (S2) Nasal Aspirator (K243138) | Geon Corporation | 2025-02-04 |
| Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (K243182) | Momentis Surgical , Ltd. | 2025-02-03 |
| BTL-754 (K241270) | BTL Industries, Inc. | 2025-01-30 |
| Co-Ablation System with Sterile Co-Ablation Probe (K243042) | Hygea Medical Technology Co., Ltd. | 2025-01-29 |
| Self-Forming Magnet (FLEX SFM) (K243213) | GI Windows, Inc. | 2025-01-29 |
| LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (K243423) | Shenzhen Rainbow Technology Co., Ltd. | 2025-01-28 |
| CO2 Laser Therapy Systems (SHE-LSP003-1) (K242941) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-01-27 |
| Symani Surgical System (820-03830) (K250014) | Medical Microinstruments, Inc. | 2025-01-27 |
| Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (K241107) | Indiba S. A. U. | 2025-01-24 |
| Reverso Pro System (K243139) | Indiba S. A. U. | 2025-01-22 |
| JETT Medical II (K240311) | Compex, Spol, S.R.O. | 2025-01-22 |
| Suture-TOOL System (K242835) | Suturion AB | 2025-01-22 |
| Advanced Cryo Wart Remover (K242288) | Medical Brands Laboratories B.V. | 2025-01-21 |
| Oligio X (K243929) | Wontech Co., Ltd. | 2025-01-21 |
| ProGrip™ Self-Gripping Polypropylene Mesh (K243315) | Sofradim Production | 2025-01-17 |
| The ETHICON™ Total Energy System (K243067) | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025-01-17 |
| GEM ZIPCLIP (K242541) | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025-01-15 |
| AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860) | AtriCure, Inc. | 2025-01-15 |
| AAMI Level 4 Protective; Gown (K242689) | Azac Group | 2025-01-13 |
| LetsGetChecked Impress (K242680) | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| Ulike Reglow Light Therapy Device (UM10) (K243492) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-01-10 |
| Erchonia Zerona® VZ8 (K243811) | Erchonia Corporation | 2025-01-10 |
| Inbella RF System (K243737) | Inbella Medical, Inc. | 2025-01-03 |
| DUET-V (Model: ESK-3261DV) (K233118) | Eunsung Global Corp | 2025-01-03 |
| Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) (K242789) | Dongguan Laiguang Electronic Technology Co., Ltd. | 2025-01-02 |
| Nasal Aspirator (NS 13) (K241852) | Avita Corporation | 2024-12-31 |
| Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K243445) | Bios S.R.L. | 2024-12-30 |
| PAL Aspiration System (K242804) | Microaire Surgical Instruments, LLC | 2024-12-30 |
| Diode Laser System model Dawn-S (K243037) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-12-26 |
| Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (K243141) | Jiangxi Medex Technology Co., Ltd. | 2024-12-26 |
| FISIOWARM 7.0 (K232966) | Golden Star Srl | 2024-12-26 |
| 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 |