| Genadyne DUO NPWT (K233614) | Genadyne Biotechnologies, Inc. | 2024-12-23 |
| SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; (K243121) | Jiangxi Medex Technology Co., Ltd. | 2024-12-22 |
| LGO-Surgical Laser Fibers (K243147) | Light Guide Optics International , Ltd. | 2024-12-21 |
| IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) (K243085) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-12-21 |
| SmartClip Secure Soft Tissue Marker (K233639) | Elucent Medical, Inc. | 2024-12-20 |
| Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (K241670) | Beijing Adss Development Co., Ltd. | 2024-12-20 |
| Finiff System (K242688) | Skingrab Co., Ltd. | 2024-12-20 |
| HandPICO Fractional Laser Handpiece Tip (K242534) | Vydence Medical | 2024-12-20 |
| LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) (K243040) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2024-12-20 |
| OviTex PRS (Long-Term Resorbable) (K243595) | TELA Bio, Inc. | 2024-12-19 |
| UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (K242908) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 |
| Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (K242700) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-12-19 |
| Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (K242370) | Medline Industries, LP | 2024-12-19 |
| Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (K242987) | Allengers Global Healthcare Private Limited | 2024-12-17 |
| Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (K241998) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-12-13 |
| Medicon Epiplating System (K241253) | Cmf Medicon Surgical, Inc. | 2024-12-12 |
| FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) | ZuriMED Technologies AG | 2024-12-11 |
| 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 |
| NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (K242687) | AngioDynamics, Inc. | 2024-12-06 |
| Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) (K242710) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2024-12-06 |
| Verruca-Freeze H (K243454) | Cryosurgery, Inc. | 2024-12-03 |
| Sofsilk™ Coated Braided Silk Suture (K241486) | Covidien | 2024-12-03 |
| Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (K243418) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 |
| AirSculpt Body Contouring System (AIRS-1-SYS) (K241835) | Cellmyx | 2024-11-27 |
| LED Light Therapy Machine (G1, G3, G4, G6) (K242638) | Shenzhen Walton Technology Co., Ltd. | 2024-11-27 |
| BioBrace® (K242187) | Conmed Corporation | 2024-11-27 |
| SmoothSkin Pure Switch (SSC1) (K243362) | Cyden Limited | 2024-11-27 |
| CryoGlow (FW3XXXX) (K242796) | Sharkninja Operating, LLC | 2024-11-27 |
| Nexpowder (K240994) | Nextbiomedical Co., Ltd. | 2024-11-27 |
| REGENETEN™ Bioinductive Implant (K242631) | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 |
| Cellinew (K240897) | VIOL Co., Ltd. | 2024-11-26 |
| MIRARI® Cold Plasma System ( GV-M2-01) (K242553) | General Vibronics, Inc. | 2024-11-21 |
| Secret MAX Multi-platform RF System (K241157) | Ilooda Co,., Ltd. | 2024-11-21 |
| INDIBA COMPACT devices (K243164) | Indiba S. A. U. | 2024-11-20 |
| Medical Thulium Fiber Laser Systems (UroFiber 60Q) (K242293) | Rhein Laser Technologies Co., Ltd. | 2024-11-19 |
| Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (K242028) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 |
| Diode laser Treatment System (K18) (K241498) | Hebei Keylaser Sci-Tech Co.,Ltd | 2024-11-18 |
| ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (K241138) | Livsmed, Inc. | 2024-11-15 |
| Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (K243306) | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 |
| AdVance™ XP Male Sling System (720163-03) (K242960) | Boston Scientific Corporation | 2024-11-15 |
| DEFINE System (AG612444A) (K242598) | InMode , Ltd. | 2024-11-14 |
| Veincare (K241930) | Wontech Co., Ltd. | 2024-11-14 |
| Intense Pulsed Light Treatment System (LK-PT) (K242440) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| Aurelia Surgical Mask ASTM Level-3 (2130) (K242502) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 |
| Superflow Prime Treatment System (ASP-1M) (K242286) | Guangzhou Aimira Innovation Technology Co, Ltd. | 2024-11-08 |
| décoLITE LED Device (K242382) | iSMART Developments, Ltd. | 2024-11-08 |
| Plasonic (Plasonic) (K241099) | Hironic Co., Ltd. | 2024-11-08 |
| Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (K242595) | Shenzhen Greatro Electronic Technology Co., Ltd. | 2024-11-07 |
| Trilogy Tissue Marker (K240429) | Inrad, Inc. | 2024-11-07 |
| Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) (K242039) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-11-06 |
| Compound W Skin Tag Remover (K242803) | Medtech Products, Inc. | 2024-11-06 |
| POTENZA (K231287) | Jeisys Medical, Inc. | 2024-11-05 |
| gentleheel® Adult Incision Device (K242664) | Gri-Alleset, Inc. | 2024-11-05 |
| ORTIV (ORTIV-BL, ORTIV-WH) (K241646) | Mvitro Co., Ltd. | 2024-11-01 |
| Legend X Desktop System (K243217) | Pollogen, Ltd. | 2024-11-01 |
| Safety Lancet (K242627) | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| Edison System (K241902) | HistoSonics, Inc. | 2024-10-30 |
| TRACHEOBRONXANE™ DUMON® (K243126) | Novatech SA | 2024-10-29 |
| Sterile Lancets for Single Use (K242622) | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 |
| Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K241718) | Shenzhen Aozemei Technology Co., Ltd. | 2024-10-28 |
| ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (K241630) | Ethicon Endo-Surgery, LLC | 2024-10-28 |
| Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (K243030) | Ulike Co., Ltd. | 2024-10-25 |
| Dexter L6 System (DEN230084) | Distalmotion SA | 2024-10-25 |
| Freeze Point & Private Label Versions (K242625) | Cryoconcepts LP | 2024-10-25 |
| MagDI System (MAG-01, DS-01) (K242086) | Gt Metabolic Solutions, Inc. | 2024-10-24 |
| Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (K240543) | Medency S.R.L. | 2024-10-24 |
| Fractional CO2 Laser Therapy System (EXFU CO2) (K242183) | Weifang Mingliang Electronics Co., Ltd. | 2024-10-23 |
| PuraStat (K242250) | 3-D Matrix Europe SAS | 2024-10-22 |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K242266) | Stryker Instruments | 2024-10-21 |
| Anovo Surgical System (Model 6Ne) (K242157) | Momentis Surgical , Ltd. | 2024-10-21 |
| Surgical Face Mask (Tie on/ Ear loops) (K240916) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| FREDDO (K242132) | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | 2024-10-18 |
| SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (K222944) | Safepath Medical, Inc. | 2024-10-18 |
| Dental Barrier and Sleeves (K242435) | Wellmed Dental Medical Supply Co., Ltd. | 2024-10-18 |
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (K242197) | Shenzhen Huaruibo Electric Appliances Co., Ltd. | 2024-10-17 |
| Stryker Steri-Shield 8 Surgical Hoods and Togas (K241272) | Stryker Instruments | 2024-10-16 |
| LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (K241857) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-10-11 |
| Versius Surgical System (DEN230078) | Cmr Surgical Limited | 2024-10-11 |
| Accure Laser System (K242035) | Accure Acne, Inc. | 2024-10-11 |
| Monotime and Optime R (K233265) | Peters Surgical | 2024-10-11 |
| Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092) | Quanta System Spa | 2024-10-10 |
| Lasya-Trinity (K241951) | BLUECORE COMPANY Co., Ltd. | 2024-10-10 |
| eMVFit (MVF-10M) (K240991) | Weero Co., Ltd. | 2024-10-09 |
| SER Pen Carain MicroSystem (MP1209SP) (K241355) | Su-Ko Technologies, LLC | 2024-10-09 |
| MEDIYAG (K231948) | Medicreations, LLC | 2024-10-09 |
| Electroporation System (N3000) (K240376) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 |
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) (K242679) | Fengh Medical Co., Ltd. | 2024-10-04 |
| RejuvaKnee™ Collagen Meniscus Implant (K242302) | Collagen Matrix, Inc. | 2024-10-02 |
| Anovo Surgical System (model 6N) (K241907) | Momentis Surgical , Ltd. | 2024-10-02 |
| AQUABEAM Robotic System (AB2000) (K241952) | Procept Biorobotics | 2024-09-30 |
| ACTIVO (K242206) | Daeju Meditech Engineering Co., Ltd. | 2024-09-27 |
| HIGHERDOSE Red and Infrared Light Mask (MK66-L) (K241933) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-09-27 |
| Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (K242571) | Hyundae Meditech Co., Ltd. | 2024-09-27 |
| Microwave Ablation Generator (KY-2000A, KY-2100A) (K241827) | Canyon Medical, Inc. | 2024-09-26 |
| MOLLI 2 System (K234149) | Molli Surgical, Inc. | 2024-09-26 |
| Vybe RF II (K241535) | ShenB Co., Ltd. | 2024-09-25 |