| MY01 Continuous Compartmental Pressure Monitor (K242997) | MY01, Inc. | 2025-03-13 |
| Apex Locator (K242383) | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 |
| Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001) | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 |
| NovoSorb® MTX (K242149) | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 |
| Remi Custom Night Guard (K243516) | Grindguard, Inc. | 2025-02-10 |
| Electronic Apex Locator (Alpha Apex I) (K242765) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 |
| PuraStat (K242634) | 3-D Matrix Europe SAS | 2025-01-15 |
| MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271) | Mentor Worldwide, LLC | 2025-01-13 |
| Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836) | Mentor Worldwide, LLC | 2025-01-12 |
| DermiSphere Dermal Template (K241904) | Fesariustherapeutics, Inc. | 2025-01-06 |
| Elemental Granulate (K241283) | Zinkh NV | 2025-01-03 |
| Bovine Dermis Collagen Dermal Matrix (K243071) | Collagen Matrix, Inc. | 2024-12-19 |
| BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (K242146) | Smith & Nephew Medical Limited | 2024-12-17 |
| LUOFUCON® Silver Collagen Dressing (K240809) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 |
| Atrauman® Ag (K242758) | Hartmann USA, Inc. | 2024-12-09 |
| Ion 3D (K243265) | SurGenTec, LLC | 2024-12-04 |
| Tenex 2nd Generation System (K241700) | Trice Medical, Inc. | 2024-11-18 |
| LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (K242856) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 |
| Microdacyn Hydrogel (K240510) | Sonoma Pharmaceuticals, Inc. | 2024-11-08 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (K243181) | Bionova Medical, Inc. | 2024-10-31 |
| Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (K222740) | Speciality Fibres and Materials, Ltd. | 2024-10-21 |
| Corplex P/ Theracor P/ Allacor P (K242828) | Stimlabs, LLC | 2024-10-18 |
| ABCcolla® Collagen ADM Scaffold (K233378) | Acro Biomedical Co., Ltd. | 2024-10-18 |
| Microlyte Ag/Lidocaine (K211943) | Imbed Biosciences | 2024-10-17 |
| LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (K240485) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 |
| zLOCK Lumbar Facet Fixation System (K242650) | Zygofix , Ltd. | 2024-09-20 |
| Derma-R Cream (Derma-R Cream) (K240722) | Raya Pharmaceuticals, LLC | 2024-09-20 |
| Microdacyn Wound Care Solution (K233399) | Sonoma Pharmaceuticals, Inc. | 2024-09-13 |
| MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552) | Mentor Worldwide, LLC | 2024-09-06 |
| Sealer Solvent (K241354) | Inter-Med, Inc. | 2024-08-27 |
| LIJIA Night Guard (K241369) | Lijia, LLC | 2024-08-22 |
| Kerecis Parvus (50207) (K241080) | Kerecis Limited | 2024-08-21 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (K240298) | Bionova Medical, Inc. | 2024-08-21 |
| TRAUMAGEL® (K240713) | Cresilon, Inc. | 2024-08-14 |
| GR Resin System MSI (K231775) | Pro3Dure Medical | 2024-08-08 |
| Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (K241311) | Bernhard Förster GmbH | 2024-08-02 |
| MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918) | Mentor Worldwide, LLC | 2024-08-02 |
| Silverlon® Wound Contact, Burn Contact Dressing (K241225) | Argentum Medical, LLC | 2024-07-31 |
| InnovaMatrix®FD (K241866) | Convatec Triad Life Sciences, LLC | 2024-07-26 |
| coactiv+™ Antimicrobial Wound Gel (K241809) | Kane Biotech, Inc. | 2024-07-19 |
| Field Shield Wound Dressing (K212521) | Kericure, Inc. | 2024-07-18 |
| Cytal® Wound Matrix; Cytal® Burn Matrix (K241724) | Acell, Inc. | 2024-07-11 |
| MicroMatrix® UBM Particulate (K241706) | Acell, Inc. | 2024-07-11 |
| CUSA® Clarity Ultrasonic Surgical Aspirator System (K240493) | Integra LifeSciences Corporation | 2024-07-11 |
| SiOxD® Wound Matrix (K241660) | Sioxmed, LLC | 2024-07-05 |
| Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) (K241606) | Stryker Sustainability Solutions | 2024-07-03 |
| Hello,eyes® BIO Plug (K241229) | Bio Optics Co., Ltd. | 2024-06-28 |
| PMT Posterior Cervical Stabilization System (PCSS) (K241035) | Providence Medical Technology, Inc. | 2024-06-25 |
| Ultrasonic Surgical System (K233036) | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024-06-18 |
| Irrisept Antimicrobial Wound Lavage (K240552) | Irrimax Corporation | 2024-06-18 |
| Ion 3D (K241416) | SurGenTec, LLC | 2024-06-17 |
| Slow Wave DS8 (SWDS802) (K240463) | Slow Wave, Inc. | 2024-06-04 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K232080) | Innovacyn, Inc. | 2024-05-31 |
| Anti-bacterial bandage (K232333) | Jinhua Jingdi Medical Supplies Co., Ltd. | 2024-05-31 |
| Anti Grinding Guard (K240810) | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 2024-05-24 |
| ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC (K233111) | Foshan United Medical Technologies, Ltd. | 2024-05-24 |
| Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (K240097) | Ushare Medical, Inc. | 2024-05-22 |
| Bonvadis® (K232655) | Stemcyte, Inc. | 2024-05-22 |
| SC Medica FFX (K232468) | Sc Medica | 2024-05-09 |
| LUOFUCON® Collagen Particles (Collagen Wound Dressing) (K232796) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-04-25 |
| Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (K240508) | Laclede, Inc. | 2024-04-19 |
| ReyaGel (RG03 - MTP gel 3mL) (K232204) | Fettech | 2024-04-19 |
| Hemoblock_S (Prescription); Hemoblock_S (OTC) (K232216) | Incore Co., Ltd. | 2024-04-19 |
| Miro3D Fibers Wound Matrix (K240753) | Reprise Biomedical, Inc. | 2024-04-19 |
| zLOCK Lumbar Facet Fixation System (K240085) | Zygofix , Ltd. | 2024-04-18 |
| Goyo Mouthpiece S (K232238) | Dimedikorea | 2024-04-17 |
| LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (K223360) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-03-27 |
| PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (K233151) | Medline Industries, LP | 2024-03-26 |
| RODIN 3D Resin SPLINT, Hard/Flex (K231793) | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) (K231953) | Coloplast Corp. | 2024-03-22 |
| RESPONDER® Polysaccharide Hemostat (K240454) | Starch Medical, Inc. | 2024-03-15 |
| Caphosol® Artifical Saliva (32 doses sachet box) (K234015) | Eusa Pharma (Uk) Limited | 2024-03-11 |
| MiroDry Wound Matrix (K240277) | Reprise Biomedical, Inc. | 2024-03-01 |
| Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (K233471) | Stryker Sustainability Solutions | 2024-02-20 |
| ONLINE TDM Methotrexate (K233454) | Roche Diagnostics Operations | 2024-02-20 |
| Dental LT Comfort Resin (K232087) | Formlabs Ohio, Inc. | 2024-02-16 |
| SONIK MONARK 100 (K234036) | Neuro Spinal Innovation, Inc. | 2024-02-15 |
| Apex Locator (K231990) | Cefla S.C. | 2024-02-13 |
| PainFreeze II (K232674) | Nuance Medical, LLC | 2024-02-12 |
| Ion 3D (K240086) | SurGenTec, LLC | 2024-02-08 |
| Corplex P / Theracor P / Allacor P (K231325) | Stimlabs, LLC | 2024-02-02 |
| Myoaligner Appliance (K230548) | Myohealth Technologies, LLC | 2024-02-02 |
| NailLift (K230841) | Jps Corporation | 2024-01-22 |
| LuxCreo Dental Night Guard Resin (K230592) | LuxCreo, Inc. | 2024-01-18 |
| Copper Foam Dressing (Prescription and OTC) (K231088) | Roosin Medical Co., Ltd. | 2024-01-11 |
| LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing (K221110) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-01-04 |
| Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (K232717) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 |
| LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (K223359) | Huizhou Foryou Medical Devices Co., Ltd. | 2023-12-21 |
| ARK Methotrexate II Assay (K232017) | Ark Diagnostics, Inc. | 2023-12-20 |
| PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) | Providence Medical Technology, Inc. | 2023-12-19 |
| SiOxD Wound Matrix (K232847) | Sioxmed, LLC | 2023-12-18 |
| FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (K232877) | K&J Consulting Corporation | 2023-12-13 |
| MiroTract Wound Matrix (K231614) | Reprise Biomedical, Inc. | 2023-12-13 |
| RESPONDER Polysaccharide Hemostat (K220525) | Starch Medical, Inc. | 2023-12-04 |
| Antibacterial Gel Wound Dressing (K231057) | Winner Medical Co., Ltd. | 2023-12-01 |
| Comatryx OTC (K232758) | Strukmyer Medical, LLC | 2023-12-01 |
| Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece (K222845) | Frey Oral Technologies, LLC | 2023-11-28 |
| HealiAid Dental Collagen Wound Dressing (K230529) | Maxigen Biotech, Inc. | 2023-11-22 |
| Celox Rapid X-Ray Gauze (K230589) | Medtrade Products , Ltd. | 2023-11-17 |
| Polyver Silver Alginate Dressing (Prescription and OTC) (K230190) | Roosin Medical Co., Ltd. | 2023-11-17 |