| Banded Face Mask (K223003) | Hubei Medlink Healthcare Co., Ltd. | 2022-11-18 |
| MANTA Laser (K222701) | Squalus Med , Ltd. | 2022-11-18 |
| Facet Blood Lancets (K222539) | Facet Technologies, LLC | 2022-11-18 |
| Alexandrite and Nd:YAG Laser models CANLASE and TORLASE (K222673) | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-17 |
| Accure Laser (K222109) | Accure Acne, Inc. | 2022-11-17 |
| IPL Hair Removal Device (K222598) | Shenzhen Noble Smart Manufacturing Tech Co., Ltd. | 2022-11-17 |
| C.C. LIFE 21 (K213295) | 21 Equipment S.R.L. | 2022-11-17 |
| Supra Non-Stick Bipolar Forceps (K213042) | Guenter Bissinger Medizintechnik GmbH | 2022-11-17 |
| easy Claire (K223278) | Y & J Bio Co., Ltd. | 2022-11-17 |
| TFX-LT2000 Therapy Light (K211265) | Toefx, Inc. | 2022-11-17 |
| KNH Surgical Face Mask (K203528) | Knh Surgical Face Mask | 2022-11-16 |
| Disposable surgical face mask (K220302) | Shandong Aida Medical Products Co., Ltd. | 2022-11-16 |
| Surgical Gown (K212812) | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 |
| Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS (K222915) | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-15 |
| STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K221744) | ETHICON, Inc. | 2022-11-15 |
| Disposable Sterile Lancet (K222055) | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-15 |
| High Fluid-Resistant Surgical and Procedure Mask (K222749) | America’S Supply Chains | 2022-11-14 |
| Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (K222480) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 |
| Surgical Face Mask (K222529) | Xiantao Rayxin Medical Products Co., Ltd. | 2022-11-14 |
| Dermal Cooling System (K213294) | R2 Technologies, Inc. | 2022-11-10 |
| Humask Pro Vision, Humask Pro Vision 3000 (K222551) | Entreprise Premont, Inc. | 2022-11-10 |
| 10PL (K220794) | Tentech Co. , Ltd. | 2022-11-10 |
| Bodygard SFS Surgical Gown Level 4 (K221139) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 |
| Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) (K222800) | Sanhe Laserconn Tech Co., Ltd. | 2022-11-07 |
| Disposable Medical Face Mask (DF3-001) (K222697) | Wellmed Dental Medical Supply Co., Ltd. | 2022-11-04 |
| Led Mask Platinum Md (K222377) | Cellreturn Co., Ltd. | 2022-11-03 |
| Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler (K222168) | Owen Mumford, Ltd. | 2022-11-03 |
| truSculpt iD (K223110) | Cutera, Inc. | 2022-11-03 |
| OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie (K222084) | Asahi Polyslider Co., Ltd. | 2022-11-02 |
| Back 3 COLOR (K214090) | Swims America Corp | 2022-11-01 |
| POSE™ Health Care Surgical Mask (K223270) | America'S Supply Chains | 2022-11-01 |
| Disposable Safety Lancet (K221521) | SteriLance Medical (Suzhou), Inc. | 2022-10-28 |
| Disposable Surgical Gown Rk-3011C (K211060) | Xiantao Rhycom Non-Woven Products Co., Ltd. | 2022-10-28 |
| Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305) | Syntheon | 2022-10-28 |
| Arthrex BioSuture (K220880) | Arthrex, Inc. | 2022-10-27 |
| NEUROMARK System (K222032) | Neurent Medical | 2022-10-26 |
| Unistik® Pro (K222303) | Owen Mumford, Ltd. | 2022-10-25 |
| Disposable Surgical Face Mask (K212649) | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2022-10-25 |
| SafetiCET Safety Lancet (K221783) | Nsp Tech Pte, Ltd. | 2022-10-24 |
| Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (K222058) | Wrp Asia Pacific Sdn. Bhd. | 2022-10-22 |
| Hair Removal Device (Model: IPL-D26, IPL-D19) (K221643) | Shenzhen Desida Technology Co., Ltd. | 2022-10-21 |
| CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown (K210414) | Medtecs (Taiwan) Corp. | 2022-10-21 |
| Collagen P.I.N. (Percutaneous Induction Needling) (K222199) | Induction Therapies, LLC | 2022-10-21 |
| Electric nasal aspirator (K222547) | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022-10-20 |
| Disposable Surgical Gown (G4003) (K221977) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-10-20 |
| SOMAVAC 100 Sustained Vacuum System (K222856) | Somavac Medical Solutions, Inc. | 2022-10-19 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K222643) | Sirius Medical Systems B.V. | 2022-10-19 |
| TRUEdraw Lancing Device, Mini Lancing Device (K221072) | Trividia Health | 2022-10-18 |
| WavelinQ™ Generator (K222793) | C.R. Bard, Inc. | 2022-10-17 |
| Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175) | Arkray, Inc. | 2022-10-17 |
| LUDWIG Electrosurgical Device (K221574) | Aesthetics Biomedical | 2022-10-16 |
| Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) (K222284) | Applied Medical Resources Corporation | 2022-10-14 |
| PAL Infiltration System (K220318) | Microaire Surgical Instruments, LLC | 2022-10-14 |
| IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi (K222537) | Shenzhen Ishine Technology Company Limited | 2022-10-14 |
| The Oligio (K221989) | Wontech Co., Ltd. | 2022-10-13 |
| PicoWay Laser System (K220853) | Candela Corporation | 2022-10-13 |
| Fiber Laser Treatment System (K221770) | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 |
| Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (K221712) | Fotona D.O.O. | 2022-10-12 |
| The Alma Soprano Titanium (K222064) | Alma Lasers, Inc. | 2022-10-12 |
| Apyx One Console (K221830) | Apyx Medical Corporation | 2022-10-11 |
| IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 (K222432) | Hunan Guangye Biotechnology Co., Ltd. | 2022-10-11 |
| Surgical Mask (K222335) | Luoyang Sunmed Devices Co., Ltd. | 2022-10-11 |
| AAMI4 Isolation Gown (K214116) | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 |
| Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps (K213610) | Katalyst Surgical, LLC | 2022-10-07 |
| YADU Surgical Gowns (K220092) | Henan Yadu Industrial Co., Ltd. | 2022-10-07 |
| Cold Sore Device (Model: QPZ-01) (K222205) | Light Tree Ventures Europe B.V. | 2022-10-07 |
| VisionAir Patient-Specific Airway Stent (K213969) | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| PURE Laser (K222369) | Endymed Medical, Ltd. | 2022-10-07 |
| Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP (K220138) | Led Spa | 2022-10-05 |
| Aurolase Therapy, Laser Delivery Device (LDD) (K202953) | Nanospectra Biosciences, Inc. | 2022-10-03 |
| Disposable Safety Lancets (K221778) | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-10-03 |
| Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) (K222376) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-10-03 |
| Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (K221613) | Owen Mumford, Ltd. | 2022-10-03 |
| Safety Lancet (K222090) | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 |
| Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA (K221003) | Covidien | 2022-09-30 |
| Surgical Gown (Sterile); Surgical Gown (Non-sterile) (K221637) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 |
| IPL Hair Removal Device (K222316) | Shenzhen Goodwind Technology Development Co., Ltd. | 2022-09-28 |
| MTX-C1 (K212561) | Ilooda Co,., Ltd. | 2022-09-27 |
| RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (K221062) | Bionime Corporation | 2022-09-26 |
| Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) (K222266) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2022-09-26 |
| Palm NRG cellulite body device (model: Palm NRG body device) (K214015) | Heat IN A Click, LLC | 2022-09-26 |
| Resonic Rapid Acoustic Pulse Device (K222629) | Zeltiq Aesthetics, Inc. | 2022-09-25 |
| Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718) | Hartalega NGC Sdn. Bhd. | 2022-09-24 |
| Medical Surgical Mask (K222204) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2022-09-23 |
| Diosculpt (K222265) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 |
| reepot Nd; YAG laser system (K222555) | Ilooda Co,., Ltd. | 2022-09-23 |
| CellFX System (K213674) | Pulse Biosciences, Inc. | 2022-09-22 |
| TRANBERG Thermoguide Therapy System (K214125) | Clinical Laserthermia Systems, AB | 2022-09-22 |
| ProGrip Self-Gripping Polypropylene Mesh (K220540) | Covidien | 2022-09-22 |
| SurgiLance® Safety Lancet (K222224) | Medipurpose Pte. , Ltd. | 2022-09-22 |
| Dual Switch (K211605) | Laser Engineering, Inc. | 2022-09-22 |
| ArcSP Suprapubic Sling System (K222293) | Urocure, LLC | 2022-09-21 |
| MedtFine Blood Lancet (K221383) | Shanghai Carelife International Trading Co. , Ltd. | 2022-09-21 |
| PWD Negative Pressure Wound Therapy System (K212359) | Applied Tissue Technologies, LLC | 2022-09-21 |
| Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 (K221214) | Shenzhen Ionka Medical Technology Co., Ltd. | 2022-09-21 |
| Disposable Surgical Gown UM-148 (K221717) | Unimax Medical Products Co., Ltd. | 2022-09-20 |
| Surgical Face Mask (Non-sterile) (K221976) | Xiantao Junhui Plastic Products Co., Ltd. | 2022-09-20 |
| Lancet (K221839) | Hebei Xinle Sci&Tech Co., Ltd. | 2022-09-19 |
| 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown (K221819) | Winner Medical Co., Ltd. | 2022-09-19 |
| Exsalta (K221676) | Drw Medical | 2022-09-16 |