| Intense pulsed light therapy device (K232708) | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |
| LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (K230621) | Surgical Principals, Inc. | 2023-12-01 |
| ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (K233301) | Lumenis Be, Ltd. | 2023-12-01 |
| Q-Switched Nd:Yag laser (K232716) | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 |
| Diode laser therapy device (K232709) | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 |
| HYBRIDknife® flex (K232033) | Erbe Elektromedizin GmbH | 2023-11-29 |
| Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (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 (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) (K233493) | Relign Corporation | 2023-11-28 |
| Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) (K232117) | Wuhan Lotuxs Technology Co., Ltd. | 2023-11-28 |
| Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (K232222) | Medency S.R.L. | 2023-11-27 |
| CryoThin™ Surgical System and Accessories (K231661) | Medinux (Tianjin) Technologies Co., Ltd. | 2023-11-27 |
| HyperSuture (K230311) | Threadstone, LLC | 2023-11-24 |
| IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) (K232635) | Boston Scientific | 2023-11-22 |
| Medifun Lancing Device, Model No. LD-E1 (K231797) | Medifun Corporation | 2023-11-22 |
| FITme Customized Silicone Implant (K232593) | Keosan Trading Co. | 2023-11-22 |
| Biophotas Celluma CONTOUR (K232977) | Biophotas, Inc. | 2023-11-21 |
| Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force (K233351) | Hg Innovations, Ltd. | 2023-11-20 |
| Hair Removal Device, Model(s): R2815-G Pro, R2815-G (K232575) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2023-11-20 |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); (K233346) | Hg Innovations, Ltd. | 2023-11-20 |
| NEUWAVE™ Microwave Ablation System and Accessories (K231738) | Neuwave Medical, Inc. | 2023-11-16 |
| CoolSeal Trinity (K231012) | Bolder Surgical, LLC | 2023-11-15 |
| IPL Cooling Hair Removal Device (K232845) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2023-11-14 |
| BLU TOTALE (Model: ENEOB852) (K232656) | Premier North America, Inc. | 2023-11-14 |
| Accu-Chek Safe-T-Pro Plus Lancing Device (K232488) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Accu-Chek Safe-T-Pro Uno Lancing Device (K232509) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (K232241) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| Microwave Ablation System (BD-GT) (K232240) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| TissueStat (K231277) | Durastat, LLC | 2023-11-09 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K223682) | Sirius Medical Systems B.V. | 2023-11-09 |
| Biodegradable Medical surgical mask (K231155) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-11-07 |
| SCIZER (SC1-M410) (K230100) | Classys, Inc. | 2023-11-03 |
| Easycess Aspiration Pump (K233428) | Guangzhou Easycess Medical Co.,Ltd | 2023-11-03 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (K233407) | AtriCure, Inc. | 2023-11-02 |
| Nd:Yag Laser Therapy Systems (K232532) | Beijing Unt Technology Co., Ltd. | 2023-11-02 |
| Bard 3DMax Mesh (K233402) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (K231298) | Alesi Surgical, Ltd. | 2023-10-31 |
| Ultravision2™ System (K231238) | Alesi Surgical, Ltd. | 2023-10-31 |
| NuEra Tight RF Model OptiStream (K230755) | Bios S.R.L. | 2023-10-30 |
| Plaxpot Multi Plasma (K220493) | Gcs Co. Limited | 2023-10-27 |
| PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT (K230490) | Dongguan Hunter Electronic Technology Co., Ltd. | 2023-10-27 |
| DEKA AGAIN PRO family (K233090) | El.En S.P.A. | 2023-10-27 |
| MOLLI 2 (K231579) | Molli Surgical, Inc. | 2023-10-26 |
| BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645) | Avery Dennison Medical , Ltd. | 2023-10-25 |
| POWERSEAL Sealer and Divider (K231327) | Gyrus Acmi, Inc. | 2023-10-25 |
| PiXel8-RF (K233147) | Rohrer Aesthetics | 2023-10-25 |
| VVR Generator system (K222997) | Starmed Co., Ltd. | 2023-10-25 |
| PlaDuo System (K232223) | ShenB Co., Ltd. | 2023-10-24 |
| MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System (K233185) | C2dx, Inc. | 2023-10-24 |
| CleanSeal Advanced Bipolar Vessel Sealer Maryland (K231732) | Conmed Corporation | 2023-10-23 |
| GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (K231902) | Ansell Healthcare | 2023-10-20 |
| Echo (K232236) | Quanta System Spa | 2023-10-20 |
| Radio Frequency System (K231749) | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-10-19 |
| T-Line® Hernia Mesh (K232924) | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (K222214) | Thi Total Healthcare Innovation GmbH | 2023-10-17 |
| Legend X Platform (K232903) | Pollogen, Ltd. | 2023-10-17 |
| The Evolve System with the Transform Applicator (K231495) | InMode , Ltd. | 2023-10-13 |
| Monopolar Electrode Surgical Instrument (K230650) | Vhmed (Nantong) Co. , Ltd. | 2023-10-12 |
| Skypro, Surgical Gown 6021 (K230707) | Skypro Medical Supplies Company | 2023-10-12 |
| Cross Vascular RF Generator and Footswitch (optional accessory) (K232809) | Cross Vascular, Inc. | 2023-10-12 |
| IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) (K232499) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | 2023-10-11 |
| Disposable electrosurgical pencil (MD1000) (K232460) | Shenzhen Mecun Medical Supply Co., Ltd. | 2023-10-11 |
| Cautery Protective Actuation System (CPAS) (K232407) | Safer Surgeries Medical Devices, LLC | 2023-10-06 |
| Edison System (DEN220087) | HistoSonics, Inc. | 2023-10-06 |
| Standard Staple-Line Reinforcement (SSLR23) (K231603) | Standard Bariatrics, Inc. | 2023-10-06 |
| IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 (K232056) | Dongguan Lide Electric Appliance Co., Ltd. | 2023-10-06 |
| Electrode Handpieces (VCT, RFTV, BMDT series) (K232763) | RF Medical Co., Ltd. | 2023-10-04 |
| Copioumed Chemotherapy Isolation Gown (K230135) | Copioumed International, Inc. | 2023-10-04 |
| Surgical face mask (K232359) | Kingstar Medical (Xianning) Co., Ltd. | 2023-10-02 |
| PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (K231973) | Ineo Tech Sdn Bhd | 2023-09-29 |
| BeShape One™ Device (K231628) | Beshape Technologies , Ltd. | 2023-09-29 |
| Hakon, Hakon Smart (K231901) | Medical San Indústria DE Equipamentos Médicos Ltda. | 2023-09-28 |
| IPL hair removal device (K232274) | Lumenessa Corp | 2023-09-28 |
| DEKA PHYSIQ 360 (K231971) | El.En S.P.A. | 2023-09-26 |
| Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K231891) | Coloplast | 2023-09-25 |
| PEACH 2, PEACH 2 Duo, PEACH 2 go (K231977) | Foreo, Inc. | 2023-09-25 |
| B.Light Clear Evo and B.Light Restore Evo (K223919) | Bemer Int AG | 2023-09-23 |
| T-SHAPE 2 (K231092) | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 |
| Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 |
| IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 (K232183) | Shenzhen Koli Technology Co.,Ltd | 2023-09-22 |
| BTL-899F (K230467) | BTL Industries, Inc. | 2023-09-21 |
| LED Spectrum therapy instrument (K231894) | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-09-20 |
| angiOCCLUDE Ligating Clips (K230966) | A2 Medical Systems, LLC | 2023-09-19 |
| PENTO Nd:YAG and Alexandrite laser system (K231791) | Ilooda Co,., Ltd. | 2023-09-15 |
| Non absorbable Surgical Polypropylene Suture (K230746) | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| Anovo Pedestal (K232146) | Momentis Surgical , Ltd. | 2023-09-14 |
| IPL Hair Removal, Model: W-1095, W-1098 (K232124) | Shenzhen Wochuan Electronic Co., Ltd. | 2023-09-14 |
| Venus Versa PRO System (K232192) | Venus Concept, Inc. | 2023-09-11 |
| Planar LED mate (K230362) | Shenzhen Leaflife Technology Co., Ltd. | 2023-09-11 |
| AliTight (K231146) | Alic Iotech, LLC | 2023-09-08 |
| STAT Medical Device Lancing System (K230310) | Stat Medical Devices | 2023-09-08 |
| KARL STORZ Urological Laser Accessories (K230535) | Karl Storz SE & CO. KG | 2023-09-08 |
| IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 (K231800) | Shenzhen Qianyu Technology Co., Ltd. | 2023-09-07 |
| Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes (K221743) | Jiangsu Bonss Medical Technology Co., Ltd. | 2023-09-07 |
| IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 (K231717) | Foshan Jindi Electric Appliance Co., Ltd. | 2023-09-06 |
| OW100S (K231710) | Softwave/Trt, LLC | 2023-09-01 |
| Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K230578) | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 |
| Spinery™ RF Ablation System (K223303) | Axon Spine Medical System | 2023-08-30 |
| LAA Exclusion System (K232295) | Syntheon, LLC | 2023-08-30 |
| AquaBeam Robotic System (K231024) | Procept Biorobotics, Corporation | 2023-08-30 |
| Silk'n Titan Allways (K230013) | Silk'N Beauty , Ltd. | 2023-08-30 |
| LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313) | Ethicon Endo Surgery, LLC | 2023-08-29 |