| NSite Scoliosis Assessment App (K230463) | Nsite, Inc. | 2023-11-15 |
| Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937) | Bionova Medical, Inc. | 2023-11-13 |
| Skin and Wound Cleanser (K231564) | Winner Medical Co., Ltd. | 2023-11-10 |
| Mouth Guard (ATG0603R) (K231865) | Reazeal Corp | 2023-11-06 |
| Antimicrobial Gelling Fiber Dressing with PHMB (K213473) | Advanced Medical Solutions, Ltd. | 2023-10-26 |
| Motiva Flora SmoothSilk Tissue Expander (K211676) | Motiva USA, LLC | 2023-10-13 |
| APIS (R), VERIS (TM) (K222143) | Sweetbio, Inc. | 2023-10-13 |
| Serena Sleep Night Guard (K230495) | Meris Investment Group | 2023-10-13 |
| Collagen Wound Dressing (K231152) | Winner Medical Co., Ltd. | 2023-10-12 |
| FREEPRINT® splintmaster (K232448) | Detax GmbH | 2023-10-12 |
| Montage- XT Settable, Resorbable Hemostatic Bone Putty (K232998) | Orthocon, Inc. | 2023-10-12 |
| SurgiAid® Collagen Wound Dressing (K223126) | Maxigen Biotech, Inc. | 2023-10-11 |
| G4Derm / G4Derm Plus Synthetic Wound Matrix (K222025) | Gel4med, Inc. | 2023-10-11 |
| Momentum Spine (K232023) | Momentum Health, Inc. | 2023-10-04 |
| Antibacterial bandage (K221570) | Allmed Medical Products Co., Ltd. | 2023-09-29 |
| MicroMatrix® Flex (K230980) | Acell, Inc. | 2023-09-22 |
| Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) (K230237) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | 2023-09-14 |
| Hemostatic Dressing (K213413) | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 |
| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418) | Orthocon, Inc. | 2023-08-30 |
| Maxiocel Chitosan Wound Dressing (K212766) | Advamedica, Inc. | 2023-08-24 |
| GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (K231205) | Gurunanda, LLC | 2023-08-22 |
| ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing (K223526) | Smith & Nephew Medical Limited | 2023-08-18 |
| PMT Expandable Cage (PMT EXP) (K230297) | Providence Medical Technology, Inc. | 2023-08-11 |
| Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386) | Orthocon, Inc. | 2023-07-11 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K230427) | Integra LifeSciences Corporation | 2023-07-11 |
| Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (K213652) | Cresilon, Inc. | 2023-06-28 |
| neXus Ultrasonic Surgical Aspirator System (K231117) | Misonix, LLC, A Bioventus Company | 2023-06-23 |
| Antibacterial Bandage (K221311) | Winner Medical Co., Ltd. | 2023-06-21 |
| NovoGen Wound Matrix (K220498) | Novabone Products, LLC | 2023-06-09 |
| Ear Pressure Relief Device(Model:ER813B) (K230502) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| AlloX2 Pro Tissue Expanders (K214124) | Sientra, Inc. | 2023-06-08 |
| coactiv+™ Antimicrobial Wound Gel (K223259) | Kane Biotech, Inc. | 2023-05-24 |
| Introducer Needle (K222705) | Youcare Technology Co.,Ltd. (Wuhan) | 2023-05-22 |
| Restrata® MiniMatrix (K223725) | Acera Surgical, Inc. | 2023-05-18 |
| Sientra, inc. Portfinder (K221127) | Sientra, Inc. | 2023-05-10 |
| Zeolite Hemostatic Cotton (K223495) | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 |
| FortiShield (Biosynthetic Wound Matrix) (K212579) | Organogenesis, Inc. | 2023-05-02 |
| dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S (K222604) | Dentona AG | 2023-04-21 |
| Compremium Compartment Compressibility Monitoring System (CPM#1) (K223509) | Compremium AG | 2023-04-14 |
| Axiostat Gauze (K222909) | Advamedica, Inc. | 2023-04-07 |
| Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) | Advanced Medical Solutions Limited | 2023-04-05 |
| BIASURGE Advanced Surgical Solution (K223377) | Rochal Technologies, LLC | 2023-03-30 |
| Meril-Bonewax (K200452) | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 |
| Sterile Silver Alginate Wound Dressing (K220673) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2023-03-16 |
| HARMONIC 700 Shears (K221790) | Ethicon Endo-Surgery, LLC | 2023-02-28 |
| Glidewell TuffSplint™ Appliance Resin (K223798) | Prismatik Dentalcraft, Inc. | 2023-02-17 |
| Sonopet 1Q 3 7cm 1Q Large (K223770) | Stryker Corporation | 2023-02-16 |
| S.E.A.L. Hemostatic Wound Spray (K210751) | Bc3 Technologies, Inc. | 2023-02-02 |
| PHMB Wound Dressing (K221532) | Winner Medical Co., Ltd. | 2023-01-30 |
| Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (K221754) | Winner Medical Co., Ltd. | 2023-01-17 |
| Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (K221755) | Winner Medical Co., Ltd. | 2023-01-13 |
| Spectricept Skin and Wound Cleanser (K213514) | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023-01-13 |
| Visant Medical Canalicular Plug (K222164) | Visant Medical, Inc. | 2022-12-23 |
| PerioStom Dental Dressing (K221428) | Forward Science, LLC | 2022-12-22 |
| Extra Silver Gelling Fiber Dressing (K221720) | Winner Medical Co., Ltd. | 2022-12-21 |
| ELECTROCYN soma (K220286) | V3Bio Sdn. Bhd | 2022-12-21 |
| LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (K221102) | Sra Developments, Ltd. | 2022-12-15 |
| PMT Facet Fixation System (PMT FFS) (K220951) | Providence Medical Technology, Inc. | 2022-12-09 |
| Miro3D Wound Matrix (K223257) | Reprise Biomedical | 2022-11-21 |
| SiOxD Wound Matrix (K222189) | Sioxmed, LLC | 2022-11-18 |
| FBCC Night Guard (K221369) | Fbcc, Inc. | 2022-11-18 |
| Dental LT Clear V2 Resin (K222061) | Formlabs Ohio, Inc. | 2022-11-10 |
| Silverlon Wound Contact, Burn Contact Dressings (K221218) | Argentum Medical, Inc. | 2022-10-26 |
| NextDent Ortho Flex (K221022) | Vertex-Dental B.V. | 2022-10-21 |
| MEBO Wound Dressing (K222657) | Mebo Life Science, Inc. | 2022-10-18 |
| Protect-It Custom Fit Dental Guard (K222424) | Doc Brands, Inc. | 2022-10-07 |
| FaSet Fixation System (K222515) | Dio Medical Corporation | 2022-10-05 |
| Cornisol (K221759) | Aurolab | 2022-10-05 |
| Ultrasonic Surgical System (K210567) | Miconvey Technologies Co., Ltd. | 2022-09-30 |
| InnovaBurn (K213716) | Triad Life Sciences, Inc. | 2022-09-29 |
| InnovaMatrix PD (K211902) | Triad Life Sciences, Inc. | 2022-09-28 |
| LUOFUCON Collagen Wound Dressing (K213598) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-09-20 |
| NovoSorb Matrix (K221686) | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K221835) | Integra LifeSciences Corporation | 2022-08-22 |
| Bonvadis Topical Cream (K212554) | Stemcyte, Inc. | 2022-08-19 |
| Miro3D Wound Matrix (K221520) | Reprise Biomedical, Inc. | 2022-08-18 |
| Foundation Dermal Regeneration Scaffold (DRS) Solo (K210949) | Bionova Medical, Inc. | 2022-08-11 |
| Vascette HP (hemostatic pad) (K220566) | Koag, LLC | 2022-07-29 |
| neXus Ultrasonic Surgical Aspirator System (K221235) | Misonix, Inc. | 2022-07-28 |
| Root Apex Locator (K212178) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 |
| Ultrasonic Scalpel System (K212614) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022-07-18 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K221763) | Integra LifeSciences Corporation | 2022-07-15 |
| PELNAC Meshed Bilayer Wound Matrix (K213498) | Gunze Limited | 2022-07-14 |
| PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317) | Organogenesis, Inc. | 2022-07-01 |
| FridaMom Anti-Nausea Bands (K220289) | Fridababy, LLC | 2022-06-29 |
| Kerecis Silicone (K213231) | Kerecis Limited | 2022-06-29 |
| SmileGuard (K220894) | Envisiontec GmbH | 2022-06-10 |
| SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988) | Oasis Medical, Inc. | 2022-06-03 |
| Fibrillar Collagen Wound Dressing (K213341) | Collagen Matrix, Inc. | 2022-05-31 |
| CRYO Arctic, CRYO Penguin (K203661) | Cryoscience North America, Inc. | 2022-05-25 |
| MY01 Continuous Compartmental Pressure Monitor (K220952) | MY01, Inc. | 2022-05-24 |
| Geistlich Wound Matrix PLUS (K213607) | Geistlich Pharma AG | 2022-04-28 |
| GyroStim (K220231) | Ultrathera Technologies, Inc. | 2022-04-27 |
| LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (K211123) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-04-22 |
| Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (K212952) | Psychemedics Corporation | 2022-04-18 |
| Thermeo System (K212017) | Pro3Dure Medical GmbH | 2022-04-08 |
| PuraStat-RM (K213552) | 3-D Matrix, Inc. | 2022-04-01 |
| LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing (K210718) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-03-23 |
| Needle Stimulator (Model: RJNS6-1) (K220153) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-03-18 |
| Stasis Gel (K211420) | Belport Company, Inc., Gingi-Pak | 2022-03-14 |