| SofWave System (K231537) | Sofwave Medical, Ltd. | 2023-08-28 |
| Lavieen (K223727) | Wontech Co., Ltd. | 2023-08-25 |
| Non absorbable Surgical Polyester Suture (K231183) | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) (K231872) | Kirwan Surgical Products, LLC | 2023-08-25 |
| Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) (K230610) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |
| Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (K230079) | Ansell Healthcare Products, LLC | 2023-08-23 |
| Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (K231510) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 |
| Holmium Medical Laser (K231718) | Allengers Global Healthcare Private Limited | 2023-08-18 |
| Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs (K222993) | Sentienx Sdn Bhd | 2023-08-18 |
| Avéli (K232153) | Revelle Aesthetics, Inc. | 2023-08-18 |
| Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (K231777) | Olympus Winter & Ibe GmbH | 2023-08-18 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
| Phototherapy System (OL-PDT950) (K230342) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-08-16 |
| Powdered Free Sterile Natural Rubber Latex Surgical Gloves (K230832) | The Egyptian Company For Medical & Electronic Industries | 2023-08-16 |
| Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) (K230577) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 |
| Density (K230663) | Jeisys Medical, Inc. | 2023-08-14 |
| V-Laser (K231054) | Wontech Co., Ltd. | 2023-08-14 |
| PolyWear® Personal Protective Level 3 Gown (K230384) | PolyConversions, Inc. | 2023-08-11 |
| NuEra Tight RF Family (K223856) | Bios S.R.L. | 2023-08-11 |
| Dr. pen Microneedling System (K230420) | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| ZenPro 40 (K230268) | BLUECORE COMPANY Co., Ltd. | 2023-08-10 |
| SuperBall Meniscal Repair System (K223500) | Arcuro Medical , Ltd. | 2023-08-10 |
| Intense Pulsed Light System (K231394) | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
| Polyisoprene Surgical Gloves (K230304) | Puyang Linshi Medical Supplies Co., Ltd. | 2023-08-09 |
| Protective Gown AAMI Level 4 (K222128) | Kenpax International Limited | 2023-08-08 |
| Visual-ICE Cryoablation System (K230551) | Boston Scientific Corporation | 2023-08-08 |
| Surgeon Controlled Arm (K223673) | Levita Magnetics International Corp | 2023-08-04 |
| Surgical Face Masks, Model: EFMDS-L50Pn BLU (K230380) | Iris USA | 2023-08-03 |
| Medical Diode Laser, Model S1Pro (K231548) | Wuhan Pioon Technology Co., Ltd. | 2023-08-03 |
| MENIX®; MENIX® DUO (K223122) | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 |
| Eblator Device (K231126) | E Surgical, LLC | 2023-08-02 |
| Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. (K231613) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2023-07-31 |
| Surgical Sutures with or without Needle (K221767) | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 |
| SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC (K222862) | Lotuxs Medtech (Suzhou) Co., Ltd. | 2023-07-30 |
| SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073) | Esthetic Medical, Inc. | 2023-07-28 |
| 3 Layer Surgical Mask (134252531) (K231618) | Original Mattress Factory, Inc. | 2023-07-28 |
| FLUOBEAM® LX Red (K230898) | Fluoptics Sas | 2023-07-28 |
| Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets (K230838) | Cardinal Health200, LLC | 2023-07-27 |
| LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (K231555) | iSMART Developments, Ltd. | 2023-07-27 |
| Erchonia Violet ZERONA® Z6 OTC (K231474) | Erchonia Corporation | 2023-07-21 |
| VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits (K231945) | AngioDynamics, Inc. | 2023-07-20 |
| The InMode System with the Morpheus8 Applicators (K231790) | InMode , Ltd. | 2023-07-20 |
| BACK 3 (K230037) | Swims America Corp | 2023-07-19 |
| LaserME (K230077) | Neauvia North America | 2023-07-17 |
| Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) (K230395) | Durio Ppe Sdn Bhd | 2023-07-17 |
| Ultraflex™ Tracheobronchial Stent System (K230269) | Boston Scientific Corporation | 2023-07-14 |
| HydroMARK Plus Breast Biopsy Site Marker (K221961) | Devicor Medical Products, Inc. | 2023-07-13 |
| Invia® Integrated Dressing (K223388) | Medela AG | 2023-07-07 |
| MyEllevate (K230510) | Cynosure, LLC | 2023-07-06 |
| VYBE RF Electrosurgical System (K230968) | ShenB Co., Ltd. | 2023-07-06 |
| SpinMedix Absorbable Fibrous Membrane (K222220) | Celestray Biotech Company, LLC., | 2023-07-06 |
| Tissue Approximation System (TAS) (K220980) | Tas Medical, Inc. | 2023-07-05 |
| Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) (K230569) | Cardinalhealth | 2023-07-03 |
| IVYLASER Handhold Hair Removal Machine (K230025) | Ivylaser (Beijing) Technology Co.,Ltd | 2023-07-03 |
| LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (K230720) | Light Tree Ventures Europe B.V. | 2023-07-03 |
| AblatePal Radiofrequency Ablation System (K223135) | Compal Electronics, Inc. | 2023-06-30 |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K231549) | Boston Scientific Corporation | 2023-06-29 |
| AceConnex Pre-Sutured Fascia (K213046) | Allosource | 2023-06-27 |
| Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) (K231124) | Owen Mumford, Ltd. | 2023-06-27 |
| ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) (K230914) | ArthroCare Corporation | 2023-06-26 |
| AB1 Electrosurgical Instrument, Creo Electrosurgical System (K223138) | Creo Medical, Ltd. | 2023-06-26 |
| IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S (K231215) | Zhongshan Qizhe Technology Co., Ltd. | 2023-06-26 |
| Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (K230036) | Rti Surgical, Inc. | 2023-06-23 |
| Diode Laser Body Sculpture Systems (K231131) | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 |
| TargetCool™ (K230599) | Recensmedical, Inc. | 2023-06-22 |
| Miria Skin Treatment System (K223871) | AVAVA, Inc. | 2023-06-22 |
| da Vinci E-200 Electrosurgical Generator (K231212) | Intuitive Surgical | 2023-06-21 |
| Tixel® 2 System (K223033) | Novoxel , Ltd. | 2023-06-21 |
| Surgical Gown (K222999) | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 |
| IPL Hair Removal Device Models: MLY-T069 (K230473) | Miley Technology (Hebei) Co., Ltd. | 2023-06-15 |
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| Tisuthes e-PTFE Surgical Patch (K201153) | Shanghai Suokang Medical Implants Co., Ltd. | 2023-06-13 |
| SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) (K230759) | Bosungmeditech Co., Ltd. | 2023-06-13 |
| SecurePortIV Advanced Catheter Securement Adhesive (K223669) | Adhezion Biomedical, LLC | 2023-06-12 |
| Genadyne Hybrid Foam Dressings (K221888) | Genadyne Biotechnologies, Inc. | 2023-06-12 |
| Renuvion® Micro Handpiece (K230586) | Apyx Medical Corporation | 2023-06-09 |
| TheraFace Mask (K230293) | Therabody, Inc. | 2023-06-09 |
| Zionic Aesthetic (K230659) | Termosalud | 2023-06-08 |
| Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe (K222001) | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 |
| AviClear Laser System (K230660) | Cutera, Inc. | 2023-06-06 |
| Diode laser therapy device (K212733) | Beijing Star New Tech Co., Ltd. | 2023-06-06 |
| Diode laser therapy device (K212734) | Triangel Rsd Limited | 2023-06-06 |
| ArtiSential Laparoscopic Instruments-Electrodes (K230498) | Livsmed, Inc. | 2023-06-05 |
| SCAR 3 (K231309) | El.En Electroinc Engineering Spa | 2023-06-02 |
| ACTIVBRAID™ (K223822) | Embody, Inc. | 2023-06-02 |
| Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (K230990) | Candela Corporation | 2023-06-01 |
| Surgical Face Mask (L 175*95mm) (K230617) | Henan Chaoya Medical Equipment Co., Ltd. | 2023-06-01 |
| Pitch PaSoft Tissue Reinforcement Device (K230671) | Xiros, Ltd. | 2023-05-31 |
| BTL-785X (K222556) | BTL Industries, Inc. | 2023-05-31 |
| Hydrozid Precise (K221897) | Bibawo Medical A/S | 2023-05-30 |
| Victan (K230593) | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2023-05-30 |
| FlexBand; FlexPatch; FlexBand Plus (K230316) | International Life Sciences | 2023-05-26 |
| Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 (K230739) | Shenzhen Ionka Medical Technology Co., Ltd. | 2023-05-26 |
| Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (K213289) | Ansell Healthcare Products, LLC | 2023-05-26 |
| Diode Laser System (K230580) | Smedtrum Medical Technology Co., Ltd. | 2023-05-26 |
| ThermoTK (K213256) | Zimmer Medizinsysteme GmbH | 2023-05-25 |
| Laser Thermal Therapy Kit (K230460) | Elesta S.P.A | 2023-05-22 |
| HELIOS 785 Pico (K230373) | Laseroptek Co., Ltd. | 2023-05-22 |
| Disposable Medical Mask (K222545) | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-05-19 |
| Single Use Bipolar Forceps (K230432) | Hg Innovations, Ltd. | 2023-05-18 |