| PICOANDY (Q-Switched Nd:YAG Laser) (K234104) | Wontech Co., Ltd. | 2024-03-15 |
| Define RF Microneedling System (K232301) | Aesthetic Management Partners | 2024-03-14 |
| Edison System (K233466) | HistoSonics, Inc. | 2024-03-13 |
| ICEfx Cryoablation System (FPRCH8000-02) (K234002) | Boston Scientific | 2024-03-13 |
| Smartxide Tetra Pro (K240497) | El.En S.P.A. | 2024-03-12 |
| EmoLED (v. 2-USA) (K240132) | Emoled, Srl | 2024-03-12 |
| WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K234046) | Boston Scientific Corporation | 2024-03-08 |
| Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) (K240264) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2024-03-08 |
| CellFX Percutaneous Electrode System (SYS3000) (K233705) | Pulse Biosciences, Inc. | 2024-03-08 |
| Elite iQ PRO (M122K1) (K240396) | Cynosure, LLC | 2024-03-08 |
| Disposable Bipolar Forceps (K232703) | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2024-03-06 |
| CurrentBody Skin RF (K232424) | El Global Trade, Ltd. | 2024-03-06 |
| Medline Open-back Level 3 Protective Gown (K233526) | Medline Industries, LP | 2024-03-05 |
| Medical Diode Laser Systems (K230047) | Gigaalaser Company , Ltd. | 2024-03-04 |
| NUNA LUX (NUNL528) (K233862) | Premier North America, Inc. | 2024-03-01 |
| PlazMagik (K230837) | Agnes Medical Co., Ltd. | 2024-02-29 |
| NPseal (Small, Medium, Large) (K240244) | Guard Medical, Inc. | 2024-02-29 |
| Dawn Diode Laser System (K232885) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-02-28 |
| OsteoCool™ 2.0 RF Ablation System (K233830) | Medtronic Sofamor Danek USA, Inc. | 2024-02-28 |
| Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (K233879) | Maquet Cardiovascular, LLC | 2024-02-27 |
| MIRA Surgical System (DEN230025) | Virtual Incision | 2024-02-23 |
| Exceed Unlimited (K233709) | Mt. Derm GmbH | 2024-02-23 |
| Oligio X (K240313) | Wontech Co., Ltd. | 2024-02-22 |
| NanoDrop Lancet (K223826) | Drawbridge Health, Inc. | 2024-02-22 |
| MultiPulse HoPLUS (K231876) | Asclepion Laser Technologies GmbH | 2024-02-22 |
| Quiver Aspiration Pump (K232831) | Anoxia Medical, Inc. | 2024-02-22 |
| Ulthera System (UC-1 Control Unit PRIME) (K233996) | Ulthera, Inc. | 2024-02-22 |
| Diode Laser Therapy System (K231896) | Beijing Adss Development Co., Ltd. | 2024-02-20 |
| Mjolnir Pro. (Multi–electrode plasma) (K233760) | Shenzhen Leaflife Technology Co., Ltd. | 2024-02-20 |
| Disposable Grounding Pad (K231985) | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-02-16 |
| Azure (K231514) | Daeshin Enterprise Co., Ltd. | 2024-02-14 |
| Transorb™ Self-Gripping Resorbable Mesh (K233661) | Sofradim Production | 2024-02-13 |
| SCOUT MD Surgical Guidance System (K231468) | Merit Medical System, Inc. | 2024-02-12 |
| AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G (K232072) | H.S Hospital Service S.P.A | 2024-02-09 |
| Alma Harmony (K233024) | Alma Lasers, Inc. | 2024-02-08 |
| Cryojet Plus (SHE-ACP001-1) (K233416) | Beijing Sano Laser S&T Development Co.,Ltd | 2024-02-06 |
| PREVENT Kit (K232379) | Clear Choice Therapeutics | 2024-02-05 |
| PiXel8-Reveal (K233143) | Rohrer Aesthetics | 2024-02-02 |
| Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) (K233756) | Rhein Laser Technologies Co., Ltd. | 2024-02-02 |
| Surgical Gown (40083) (K233183) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| Resonic Rapid Acoustic Pulse Device (K233804) | Zeltiq Aesthetics, Inc. | 2024-02-01 |
| Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140) | Hygea Medical Technology Co., Ltd. | 2024-01-31 |
| DermRays Revive (K231910) | Wuhan Lotuxs Technology Co., Ltd. | 2024-01-30 |
| VIVA combo RF System (VIVA combo RF System) (K234140) | Starmed Co., Ltd. | 2024-01-30 |
| Epilaser Pro (K233224) | Epilady 2000, LLC | 2024-01-27 |
| Facet Aurora Reusable Lancet Base (K232912) | Facet Technologies, LLC | 2024-01-25 |
| FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) (K233425) | Sutter Medizintechnik GmbH | 2024-01-25 |
| SchurSign Tissue Marker (K230836) | Surgmark GmbH | 2024-01-23 |
| IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) (K233887) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-01-22 |
| Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode (K231405) | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 2024-01-18 |
| FlashHeal 2 (FlashHeal 2.0) (K233077) | Inwound Aps | 2024-01-18 |
| Progrip™ Self-Gripping Polypropylene Mesh (K232373) | Sofradim Production | 2024-01-18 |
| Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) (K233796) | SteriLance Medical (Suzhou), Inc. | 2024-01-16 |
| Hilzo Esophageal Stents (K223266) | Thoracent, Inc. | 2024-01-16 |
| Non absorbable Surgical Silk Suture (K232355) | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 |
| LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) (K232615) | Devicor Medical Products, Inc. | 2024-01-12 |
| Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small (K233022) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-12 |
| DermaSensor (DEN230008) | Dermasensor, Inc. | 2024-01-12 |
| Hem-o-lok® Ligating Clips (K232970) | Teleflex Medical | 2024-01-12 |
| Cypris eXact Suturing System (K233355) | Cypris Medical | 2024-01-12 |
| LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) (K233114) | Shenzhen Idea Light Limited | 2024-01-12 |
| IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) (K233664) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-01-11 |
| HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) (K232894) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-08 |
| Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 (K233615) | Baisheng Medical Co., Ltd. | 2024-01-08 |
| Air Gap Fiber (K232106) | Wontech Co., Ltd. | 2024-01-08 |
| Solon (K221766) | Lmg Lasers Comercio, Importacao E Exportacao Ltda | 2024-01-05 |
| IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) (K233679) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-01-05 |
| HS Fiber Sutures (K231163) | Riverpoint Medical | 2024-01-05 |
| Lancing System (K232330) | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 |
| LED Eye mask (EY-20R, A20, EY-20N) (K233556) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-01-04 |
| MOSAIC 3D (Surgical Laser) (K233550) | Lutronic Aesthetic | 2024-01-02 |
| Omnimax S3, Omnimax S4 (K233304) | Sharplight Technologies, Ltd. | 2023-12-22 |
| VIO System (V-1000) (K232789) | Enspectra Health, Inc. | 2023-12-22 |
| SofWave System (K233104) | Sofwave Medical, Ltd. | 2023-12-22 |
| Kangbeier Child Surgical Mask (K221753) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| PICOSECOND Nd:YAG Laser System (K233018) | Ids, Ltd. | 2023-12-21 |
| Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (K232444) | Grand Work Plastic Products Co., Ltd. | 2023-12-20 |
| 10THERMA (K232992) | Tentech, Inc. | 2023-12-20 |
| SmoothSkin Pure Adapt (SSG3) (K233782) | Cyden Limited | 2023-12-20 |
| IPL Hair Removal Device (K232939) | Shenzhen Borria Technology Co., Ltd. | 2023-12-15 |
| xeo+ Family (K233237) | Cutera, Inc. | 2023-12-15 |
| FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (K233564) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 |
| Secret Pro (K233374) | Ilooda Co,., Ltd. | 2023-12-14 |
| SofWave System (K232455) | Sofwave Medical, Ltd. | 2023-12-14 |
| DT Controlled Phototherapy Equipment (K233811) | Daavlin Distributing Co. | 2023-12-13 |
| Radiant Renewal Skincare Wand (HD-15, HD-15A) (K232863) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-12-13 |
| SIRA™ RFA Electrosurgical Device (K232947) | Innoblative Designs, Inc. | 2023-12-12 |
| Hygenix (K232797) | Shenzhen Hygenix Industrial Co., Ltd. | 2023-12-11 |
| INTELLIO SHIFT System (K232290) | ArthroCare Corporation | 2023-12-11 |
| NeuroBlate System (K231061) | Monteris Medical, | 2023-12-08 |
| Led Mask Platinum Exclusive MD (K232795) | Stg24 Co., Ltd. | 2023-12-07 |
| Light Based Hair Removal Device (K232846) | Shenzhen Meik Beauty Industry Co., Ltd. | 2023-12-07 |
| Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (K230677) | Cork Medical | 2023-12-06 |
| SG Lanset I, SG Lancets, Soft Lancets (K230712) | Sewon Medical Co. | 2023-12-06 |
| BeaMed Laser Surgery Fibers (K232769) | Bt Beamedical Tachnoogies Ltd. (Beamed) | 2023-12-06 |
| Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 (K231005) | Supermax Healthcare Canada-Supermax Medical | 2023-12-05 |
| Disposable Endoscopic Bipolar (K231615) | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2023-12-05 |
| Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (K230734) | Precision Healing, LLC | 2023-12-05 |
| Intense Pulse Light Therapeutic Apparatus (K232932) | Shenzhen Greatro Electronic Technology Co., Ltd. | 2023-12-04 |
| Verruca-Freeze® H (K233347) | Cryosurgery, Inc. | 2023-12-04 |