| Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) (K232812) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-14 |
| Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K241407) | Bios S.R.L. | 2024-06-14 |
| InMode System with the Morpheus8 90 Applicator (K240017) | InMode , Ltd. | 2024-06-13 |
| BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E (K241358) | Sun Pharmaceutical Industries, Inc. | 2024-06-13 |
| Picosecond Nd:YAG Laser System; PICO LEGEND (K233007) | Ami, Inc. | 2024-06-12 |
| Histofreezer V (K240106) | Cryoconcepts LP | 2024-06-10 |
| Medical Diode Laser (S1Pro) (K240644) | Wuhan Pioon Technology Co., Ltd. | 2024-06-10 |
| HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) (K232806) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 |
| Grande Medical Masks, Model SF-600 (K232968) | Golden Grande Corp. | 2024-06-06 |
| ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- (K240657) | Livsmed, Inc. | 2024-06-06 |
| HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) (K232820) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-04 |
| Monteris Medical NeuroBlate System (K240877) | Monteris Medical, | 2024-06-04 |
| Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) (K240222) | Aesthetic Technology, Ltd. | 2024-06-04 |
| Maestro System (REF100) (K240598) | Moon Surgical | 2024-06-03 |
| Electro Lube NXT (K241055) | Steris | 2024-05-31 |
| IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) (K240969) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2024-05-31 |
| SofWave System (K240687) | Sofwave Medical, Ltd. | 2024-05-30 |
| Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter (K232505) | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-05-30 |
| Temperature Sensor Probe (ABL-18TP20) (K240784) | Varian Medical Systems, Inc. | 2024-05-29 |
| InnoVoyce VYLO (K240159) | Innovoyce | 2024-05-29 |
| Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) (K240874) | Theralaser Medtech (China) Co., Ltd. | 2024-05-28 |
| Regenalase Laser System (K233344) | Ipg Medical | 2024-05-28 |
| Renasys Edge (K231939) | Smith & Nephew Medical, Ltd. | 2024-05-24 |
| 3DMatrix Surgical Mesh (K232602) | Printbio, Inc. | 2024-05-23 |
| CWM-930S, FIXER DV9 (K233120) | Chungwoo Co., Ltd. | 2024-05-23 |
| 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) (K241134) | Kci USA, Inc. | 2024-05-23 |
| INUMI™ Flex Needle (K233884) | Galvanize Therapeutics, Inc. | 2024-05-22 |
| Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) (K241106) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2024-05-22 |
| Gladiator (K233099) | Rohrer Aesthetics, LLC | 2024-05-22 |
| OviTex PRS (K241126) | TELA Bio, Inc. | 2024-05-22 |
| Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (K240806) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 |
| Diode Laser Hair Removal System (SH-VD910) (K240520) | Beijing Sea Heart International Science and Technologyco.Ltd | 2024-05-20 |
| Multi-function Platform Systems (BL-M10) (K240474) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-20 |
| Intense Pulsed Light System (ST-690) (K240482) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| Kahook Dual Blade Glide (KDB Glide) (K220891) | New World Medical, Inc. | 2024-05-17 |
| DEKA LOTUS (K233473) | El.En S.P.A. | 2024-05-16 |
| Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (K232849) | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 |
| DEKA TORO (K240752) | El.En S.P.A. | 2024-05-16 |
| Picosecond Nd:YAG Laser Systems (BL-C10) (K240386) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-16 |
| 1060nm laser body slimming machine (K240658) | Hebei JT Medical Co., Ltd. | 2024-05-13 |
| HyperSuture Extension Line (K234079) | Threadstone, LLC | 2024-05-10 |
| Dental Barrier and Sleeves (K233918) | Yongqing Huaguan Dental Instruments Factory | 2024-05-09 |
| Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) (K241008) | Relign Corporation, Subsidiary of Zimmer Biomet | 2024-05-08 |
| Legend X Applicator VO (K240999) | Pollogen, Ltd. | 2024-05-08 |
| FLOW 90? Wand (K240964) | ArthroCare Corporation | 2024-05-08 |
| UltraClear Laser System (N/A) (K233803) | Acclaro Corporation | 2024-05-08 |
| Geneo X Elite (K233766) | Pollogen, Ltd. | 2024-05-07 |
| Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (K240297) | Us Medical Innovations, LLC | 2024-05-03 |
| Cypris eXact Suture Placement Device (K240185) | Cypris Medical | 2024-05-03 |
| VaporMAX LDD; MOJo LDD; MegaJOULE LDD (K233157) | Innovaquartz, LLC | 2024-05-03 |
| ORskin Blue (K232858) | Megabay S.A. | 2024-05-01 |
| Picosecond Nd:YAG Laser System (K240118) | Smedtrum Medical Technology Co., Ltd. | 2024-04-30 |
| Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939) | Boston Scientific | 2024-04-29 |
| Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (K232511) | Surgical Instrument Service and Savings, Inc. | 2024-04-29 |
| Volnewmer™ (K240248) | Classys, Inc. | 2024-04-29 |
| 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (K232246) | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 |
| Kronos Electrocautery Device (K232805) | Single Pass, Inc. | 2024-04-25 |
| IPL Home Use Hair Removal Device (SJ15) (K240093) | Shenzhen Shuge Medical Beauty Devices Co., Ltd. | 2024-04-24 |
| MeDioStar (K240816) | Asclepion Laser Technologies GmbH | 2024-04-23 |
| mJOULE RF System and Accessories (K222958) | Sciton, Inc | 2024-04-23 |
| BTL-499 (K233849) | BTL Industries, Inc. | 2024-04-23 |
| ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) (K234147) | Microline Surgical, Inc. | 2024-04-23 |
| swiftPro™ System (K240518) | Emblation Limited | 2024-04-23 |
| FAQ™ 201, FAQ™ 202 (K240378) | Foreo, Inc. | 2024-04-19 |
| Prospera Spectruum Negative Pressure Wound Therapy System (K230233) | Deroyal Industries, Inc. | 2024-04-18 |
| Disposable Medical Face Mask (M643BE) (K240258) | Makrite Industries, Inc. | 2024-04-18 |
| Carilex VT¿200-i NX (K231646) | Carilex Medical, Inc. | 2024-04-17 |
| ReBorn (1050nm) (K233962) | Lightfective , Ltd. | 2024-04-16 |
| Co2 Laser System, Models: PureLase And VanLase (K232133) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2024-04-16 |
| TitanPico Laser Workstation (PICO-450) (K233757) | Rhein Laser Technologies Co., Ltd. | 2024-04-11 |
| 8Q10 Surclear Smoke Plume Evacuation System (K233789) | Surnic Corporation | 2024-04-10 |
| Face Patches (MT-12MA, MT-12MC) (K240089) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-04-10 |
| NIRVANA (K234057) | El.En S.P.A. | 2024-04-10 |
| GalaFLEX LITE Scaffold (K233999) | Tepha, Inc. | 2024-04-09 |
| Symani Surgical System (DEN230032) | Mmi North America, Inc. | 2024-04-05 |
| Wrinkle Treatment Device (JM2) (K240360) | Shenzhen Qianyu Technology Co., Ltd. | 2024-04-05 |
| Ice Cooling 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, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) (K240652) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-04-04 |
| Peleton Universal Single Use Power System and Attachments (K240071) | Peleton Surgical | 2024-04-04 |
| Agile Esophageal Stent System (K233837) | Boston Scientific Corporation | 2024-04-04 |
| IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) (K240282) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-04-03 |
| R&G Surgical Mask (K232112) | R&G Seguridad E Higiene Industrial S.A.C. | 2024-04-02 |
| Disposable Surgical Gown (K233068) | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| SmoothSkin Pure Unplugged (SSB3) (K240587) | Cyden Limited | 2024-03-29 |
| Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K232079) | Wrp Asia Pacific Sdn. Bhd. | 2024-03-28 |
| BTL-785S (K233604) | BTL Industries, Inc. | 2024-03-28 |
| Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) (K233838) | Medtronic, Inc. | 2024-03-28 |
| Medline ART Skin Harvesting System (DEN210049) | Medline Industries, Inc. | 2024-03-27 |
| Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) (K240389) | Hyundae Meditech Co., Ltd. | 2024-03-27 |
| LUNE™ PureHygiene (K234085) | Enamel Pure | 2024-03-25 |
| Esophageal TTS Stent (K240522) | Taewoong Medical | 2024-03-22 |
| IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories (K232568) | Ipg Medical Corporation | 2024-03-21 |
| RedDrop ONE (One) (K234081) | Reddrop DX | 2024-03-21 |
| Medical Diode Laser (Model: L2) (K240179) | Wuhan Pioon Technology Co., Ltd. | 2024-03-21 |
| SMARTXIDE PRO (K240537) | El.En S.P.A. | 2024-03-20 |
| BEED 2,5, BEED 3,8 (K233002) | Excelsior Resources, LLC | 2024-03-20 |
| Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) (K233901) | Shenzhen Desida Technology Co., Ltd. | 2024-03-20 |
| InMode RF System (K233642) | InMode , Ltd. | 2024-03-20 |
| Medical Surgical Mask (K231719) | Azur Medical Company, Inc. | 2024-03-19 |
| Meriglu Topical Skin Adhesive (K230981) | M/s. Meril Endo Surgery Private Limited. | 2024-03-16 |
| Intensity Pulsed Light Therapy System (K233307) | Beijing Adss Development Co., Ltd. | 2024-03-15 |