| NaturaJel™ Oral Wound Care Kit (K260120) | HCS Innovation, LLC | 2026-08-05 |
| PuraStat-RM (K261504) | 3-D Matrix, Inc. | 2026-08-03 |
| neXus Ultrasonic Surgical Aspirator System (K261448) | Misonix, LLC | 2026-07-30 |
| Emanate Tray (K251908) | Emanate Biomedical | 2026-07-29 |
| Collagen Wound Powder (K260596) | Ventris Medical | 2026-07-02 |
| G-Series Grind Guard (K260790) | ASESSO HEALTH, Inc. | 2026-06-25 |
| Microdacyn Wound Irrigation Solution (K261023) | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| SilverCeuticals® Antimicrobial Wound Gel (K251929) | Silverceuticals, Inc. | 2026-06-24 |
| Endoform Dermal Template (K260669) | Aroa Biosurgery , Ltd. | 2026-06-24 |
| ECMT-100 WMD (K253521) | Ecm Therapeutics, Inc. | 2026-06-18 |
| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
| Curajel™ Oral Gel (K260126) | USpharma, Ltd. | 2026-06-15 |
| Ion-L (K261209) | SurGenTec, LLC | 2026-06-11 |
| Catalyze (K253204) | BioTissue Holdings, Inc. | 2026-06-05 |
| Roosin Collagen Dressing (K253974) | Roosin Medical Co., Ltd. | 2026-06-03 |
| Permatage Flowable, Settable Hemostatic Bone Paste (K261439) | Orthocon, Inc. | 2026-06-03 |
| Roosin Collagen Powder (K254034) | Roosin Medical Co., Ltd. | 2026-06-03 |
| MuCover (proposed name) Oral Wound Dressing (K253816) | MoleculeX Co., Ltd. | 2026-05-21 |
| MatriDerm (K261224) | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (K253676) | Providence Medical Technology, Inc. | 2026-05-14 |
| StatSeal Disc (K254073) | Merit Medical Systems, Inc. | 2026-05-13 |
| BloodSTOP iX Trauma Matrix (TM-iX-20) (K253017) | Lifescience Plus, Inc. | 2026-04-30 |
| Redermo Wound Matrix (K260020) | Beijing Kreate Medical Co., Ltd. | 2026-04-16 |
| ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (K252485) | 1987 Media Limited | 2026-04-10 |
| Apex Locator (FindPex) (K252224) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 |
| IWD-Gel™ (K254191) | InnovaCorium, Inc. | 2026-04-07 |
| CyClean Cord (K254239) | SS GLOBAL | 2026-03-27 |
| MiraChlor Antimicrobial Wound Solution (K252023) | Letus Corporation | 2026-03-25 |
| Derma-Gide (K260532) | Geistlich Pharma AG | 2026-03-19 |
| DiversiVy™ Facet Screw System (K253432) | Vy Spine, LLC | 2026-03-19 |
| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| UltraPrint-Dental Hard Splint UV (K253798) | Guangzhou Heygears IMC., Inc. | 2026-03-02 |
| One-Stop (K253797) | Mediclus Co., Ltd. | 2026-02-27 |
| Allday Moisturizing Rinse (K253778) | Elevate Oral Care | 2026-02-27 |
| Owl Night Guard (K253641) | Owl Dental Lab, Inc. | 2026-02-26 |
| Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (K251700) | Speciality Fibres and Materials Limited | 2026-02-26 |
| LacertaMatrix (K260218) | Lacerta Life Sciences | 2026-02-19 |
| Earflo (EF001) (K252751) | Earflo, Inc. | 2026-02-10 |
| CollOvine™ Wound Powder (K253140) | Ovigenex, LLC | 2026-02-10 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| Device 104 Particulate (K251323) | Geistlich Pharma AG | 2026-01-22 |
| Ion-C (K251714) | SurGenTec, LLC | 2026-01-16 |
| MY01 Continuous Compartmental Pressure Monitor (K251900) | MY01, Inc. | 2026-01-16 |
| Natrelle 133S Tissue Expanders (K254126) | AbbVie | 2026-01-16 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
| PuraStat (K253923) | 3-D Matrix Europe SAS | 2026-01-07 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K251757) | Innovacyn, Inc. | 2026-01-05 |
| Theracor (K253339) | Stimlabs, LLC | 2025-12-22 |
| LacertaMatrix (K252673) | Lacerta Life Science | 2025-12-22 |
| Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (K252167) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| MatriDerm pluS+ Bi-Layer (K250864) | Medskin Solutions Dr. Suwelack AG | 2025-12-19 |
| Dental Cone; Dental Sponge (K253758) | Medizin Produkte Neustadt GmbH (Mpn) | 2025-12-18 |
| MFUSE (MS001) (K250319) | Machina Medical, Inc. | 2025-12-15 |
| TRAUMAGEL® 2.0 Hemostatic Gel (K253609) | Cresilon, Inc. | 2025-12-12 |
| Remvia NightGuard (K250743) | Remvia | 2025-12-05 |
| FFX Facet Fixation System (K250679) | Sc Medica | 2025-12-04 |
| enCore Night Guard (K252004) | Encore Guards | 2025-11-25 |
| CORUS-LX Implant (K253190) | Providence Medical Technology, Inc. | 2025-11-20 |
| LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (K250642) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| Silatrix Oral Gel (K252425) | Sa3, LLC | 2025-10-23 |
| Remi Custom Night Guard (K251778) | Remi | 2025-10-17 |
| FFX Facet Fixation System (K252153) | Sc Medica | 2025-10-16 |
| SurgiAid Collagen Wound Dressing (HA) (K242100) | Maxigen Biotech, Inc. | 2025-10-16 |
| Hemastyl(™) Wound Dressing (K250115) | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| Collagen Wound Dressing (K252001) | Winner Medical Co., Ltd. | 2025-10-10 |
| Tegaderm Post-Op Transparent Antimicrobial Dressing (K251866) | Solventum US, LLC | 2025-10-10 |
| CUSA® Clarity Ultrasonic Surgical Aspirator System (K251162) | Integra LifeSciences Corporation | 2025-10-08 |
| CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (K252059) | Artivion, Inc. | 2025-10-02 |
| Retraxil (K243910) | Kulzer, LLC | 2025-09-24 |
| XTRA4 (K251320) | Al.Chi.Mi.A. S.R.L | 2025-09-11 |
| Dermalage (K243166) | Infection Elimination Solutions, LLC | 2025-08-27 |
| Helios Dermal Scaffold (K250397) | Helios Biomedical, Inc. | 2025-08-15 |
| Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) (K250898) | Stryker Sustainability Solutions | 2025-08-14 |
| NOBILCAM IMPAK Disc (K251252) | Shandong Huge Dental Material Corporation | 2025-08-01 |
| Granudacyn® Wound Irrigation Solution (K243415) | P.G.F. Industry Solutions GmbH | 2025-07-22 |
| Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (K251845) | Kerecis Limited | 2025-07-16 |
| CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (K251885) | Providence Medical Technology, Inc. | 2025-07-10 |
| Disposable Percutaneous Nephrostomy Dilatation Kit (K250448) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-07-03 |
| RC-SwiftPrep (K250279) | Belport Company, Inc., Gingi-Pak | 2025-07-02 |
| GeniPhys Collymer Self-Assembling Scaffold (K250329) | Geniphys, Inc. | 2025-06-25 |
| NovoSorb BTM (K251567) | Polynovo Biomaterials Pty, Ltd. | 2025-06-20 |
| CollOvine™ Wound Dressing (K242985) | Ovigenex, LLC | 2025-06-20 |
| SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (K242894) | Shanghai Saints Sages Surgical Co., Ltd. | 2025-06-18 |
| Bonvadis® (K251093) | Oneness Biotech Co., Ltd. | 2025-06-09 |
| DentalJect (K243654) | Vapocoolshot, Inc. | 2025-05-30 |
| Arthrex Spine Compression FT Screw (K250920) | Arthrex, Inc. | 2025-05-22 |
| The Karma® Fixation System (K242527) | Spinal Elements, Inc. | 2025-05-21 |
| CloSYS® Dry Mouth Sensitive Mouth Rinse (K250390) | Rowpar Pharmaceuticals, Inc. | 2025-05-19 |
| Dentemp Pro-Comfort Dental Guard (K250456) | Doc Brands, Inc. | 2025-05-19 |
| Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (K243457) | Seriously Clean, Ltd. | 2025-05-02 |
| MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) | Mentor Worldwide, LLC | 2025-04-24 |
| Spectricept Skin and Wound Cleanser (K243875) | Spectrum Antimicrobials, Inc. | 2025-04-21 |
| Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (K244030) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 |
| AERO MIS Facet Fusion System (K243865) | Aurora Spine | 2025-03-24 |
| Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (K243930) | Stryker Instruments | 2025-03-24 |
| Hard Splint & Thermo-Adaptive Splint (K241729) | Whip Mix Corporation | 2025-03-18 |
| SiOxC Cream (K242406) | Sioxmed, LLC | 2025-03-13 |