Review Panel
Unknown FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,688
- Product Codes (page)
- 23
- Latest Decision
- 2026-09-29
Clearances · page 1 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| DEN260007 | SmartRead(TM) Medical Device Identifier (4100) | BridgeSource Medical Corporation | SJJ | 2026-09-29 | |
| K260031 | THERMEO® I MSI | Pro3Dure Medical GmbH | MQC | 2026-09-29 | |
| K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026-09-27 | ||
| K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | MRW | 2026-09-24 | |
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | FRO | 2026-09-22 | |
| K262559 | Mouth Guard | ChangSha ChuangDuoLe E-Commerce Co., Ltd. | OBR | 2026-09-16 | |
| K260115 | DRIM-Nail System | 41Medical AG | 2026-09-11 | ||
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | FRO | 2026-09-11 | |
| K260652 | ColActive Plus | Covalon Technologies, Ltd. | KGN | 2026-09-09 | |
| K261684 | FreezeSpray TA | Cryosurgery, Inc. | MLY | 2026-09-05 | |
| DEN250044 | Queen of Hearts (ACS AI ECG Model) | Powerful Medical, Inc. | SHS | 2026-09-03 | |
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | Orthocon, Inc. | MTJ | 2026-09-03 | |
| K261311 | HYALOMATRIX | Anika Therapeutics, Inc. | QSZ | 2026-09-02 | |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | MLY | 2026-08-27 | |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | KGN | 2026-08-27 | |
| K254256 | LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. | QSZ | 2026-08-18 | |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | FRO | 2026-08-14 | |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | FRO | 2026-08-11 | |
| K260120 | NaturaJel Oral Wound Care Kit | HCS Innovation, LLC | OLR | 2026-08-05 | |
| K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026-08-05 | ||
| K261504 | PuraStat-RM | 3-D Matrix, Inc. | PHN | 2026-08-03 | |
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | LFL | 2026-07-30 | |
| K251908 | Emanate Tray | Emanate Biomedical | OLR | 2026-07-29 | |
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026-07-21 | ||
| K260596 | Collagen Wound Powder | Ventris Medical | KGN | 2026-07-02 | |
| K253306 | BioTracker 2.0 | Biotracker, LLC | 2026-06-26 | ||
| K260790 | G-Series Grind Guard | ASESSO HEALTH, Inc. | OBR | 2026-06-25 | |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | FRO | 2026-06-24 | |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | FRO | 2026-06-24 | |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | KGN | 2026-06-24 | |
| K253404 | CLEAR Aspiration System | Insera Therapeutics, Inc. | 2026-06-24 | ||
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | KGN | 2026-06-18 | |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | FRO | 2026-06-17 | |
| K260126 | Curajel Oral Gel | USpharma, Ltd. | OLR | 2026-06-15 | |
| K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026-06-15 | ||
| K261209 | Ion-L | SurGenTec, LLC | MRW | 2026-06-11 | |
| K253204 | Catalyze | BioTissue Holdings, Inc. | KGN | 2026-06-05 | |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | MTJ | 2026-06-03 | |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | KGN | 2026-06-03 | |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | KGN | 2026-06-03 | |
| K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | OLR | 2026-05-21 | |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) | Providence Medical Technology, Inc. | MRW | 2026-05-14 | |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | KGN | 2026-05-14 | |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | FRO | 2026-05-13 | |
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | QSY | 2026-04-30 | |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. | 2026-04-24 | ||
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | QSZ | 2026-04-16 | |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 1987 Media Limited | OBR | 2026-04-10 | |
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | LQY | 2026-04-08 | |
| K254191 | IWD-Gel | InnovaCorium, Inc. | FRO | 2026-04-07 | |
| K254239 | CyClean Cord | SS GLOBAL | MVL | 2026-03-27 | |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | FRO | 2026-03-25 | |
| K260532 | Derma-Gide | Geistlich Pharma AG | KGN | 2026-03-19 | |
| K253432 | DiversiVy Facet Screw System | Vy Spine, LLC | MRW | 2026-03-19 | |
| K251999 | Promogran Prisma Collagen Matrix with ORC and Silver | Solventum Germany GmbH | FRO | 2026-03-13 | |
| K252923 | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | 2026-03-13 | ||
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | FRO | 2026-03-11 | |
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | MQC | 2026-03-02 | |
| K253797 | One-Stop | Mediclus Co., Ltd. | MVL | 2026-02-27 | |
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | LFD | 2026-02-27 | |
| K253641 | Owl Night Guard | Owl Dental Lab, Inc. | OBR | 2026-02-26 | |
| K251700 | 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 | Speciality Fibres and Materials Limited | QSY | 2026-02-26 | |
| K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026-02-20 | ||
| K260218 | LacertaMatrix | Lacerta Life Sciences | KGN | 2026-02-19 | |
| K253140 | CollOvine Wound Powder | Ovigenex, LLC | KGN | 2026-02-10 | |
| K252751 | Earflo (EF001) | Earflo, Inc. | MJV | 2026-02-10 | |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | FRO | 2026-02-02 | |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | FRO | 2026-01-23 | |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | KGN | 2026-01-22 | |
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | LCJ | 2026-01-16 | |
| K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | 2026-01-16 | |
| K251714 | Ion-C | SurGenTec, LLC | MRW | 2026-01-16 | |
| K250890 | SBC1 Cream | Sioxmed, LLC | FRO | 2026-01-12 | |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | FRO | 2026-01-08 | |
| K253923 | PuraStat | 3-D Matrix Europe SAS | PHN | 2026-01-07 | |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | FRO | 2026-01-05 | |
| K252673 | LacertaMatrix | Lacerta Life Science | KGN | 2025-12-22 | |
| K253339 | Theracor | Stimlabs, LLC | KGN | 2025-12-22 | |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | FRO | 2025-12-19 | |
| K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | KGN | 2025-12-19 | |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | OLR | 2025-12-18 | |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | QSY | 2025-12-15 | |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | QSY | 2025-12-12 | |
| K250743 | Remvia NightGuard | Remvia | MQC | 2025-12-05 | |
| K250679 | FFX Facet Fixation System | Sc Medica | MRW | 2025-12-04 | |
| K252004 | enCore Night Guard | Encore Guards | OBR | 2025-11-25 | |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | MRW | 2025-11-20 | |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | FRO | 2025-11-19 | |
| K252425 | Silatrix Oral Gel | Sa3, LLC | OLR | 2025-10-23 | |
| K251778 | Remi Custom Night Guard | Remi | OBR | 2025-10-17 | |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | KGN | 2025-10-16 | |
| K252153 | FFX Facet Fixation System | Sc Medica | MRW | 2025-10-16 | |
| K250115 | Hemastyl() Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | FRO | 2025-10-14 | |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | KGN | 2025-10-10 | |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | FRO | 2025-10-10 | |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | 2025-10-08 | |
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | OHA | 2025-10-02 | |
| K243910 | Retraxil | Kulzer, LLC | MVL | 2025-09-24 | |
| K251320 | XTRA4 | Al.Chi.Mi.A. S.R.L | LYX | 2025-09-11 | |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | FRO | 2025-08-27 |
4,688 clearances in the Unknown panel. Data: openFDA.