FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| P250003S008 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | Oct 23, 2026 |
| K263407 | Tempo Plating System | Pace Surgical | Oct 23, 2026 |
| K263380 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | Oct 23, 2026 |
| K263348 | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT | Smith & Nephew, Inc. | Oct 23, 2026 |
| K262779 | ANTHEM™ Fracture System | Globus Medical, Inc. | Oct 23, 2026 |
| K262752 | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | Oct 23, 2026 |
| K262080 | OTOPLAN | Cascination AG | Oct 23, 2026 |
| K261982 | RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) | Smith & Nephew Medical, Ltd. | Oct 23, 2026 |
| K261792 | DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent | Medtronic | Oct 23, 2026 |
| K261679 | BlineSlide | Deep Breathe, Inc. | Oct 23, 2026 |
| K261670 | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads | Poly Medicure Limited | Oct 23, 2026 |
| K261293 | EASYMAX Voice Blood Glucose Monitoring System | EPS Bio Technology Corp. | Oct 23, 2026 |
| K260776 | VENTANA MMR IHC Panel | Roche Tissue Diagnostics, Inc. | Oct 23, 2026 |
| K260640 | Kinetic Software Library | Monebo Technologies, Inc. | Oct 23, 2026 |
| K260421 | LuxDesign | LuxCreo, Inc. | Oct 23, 2026 |
| K260302 | B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC | B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) | Oct 23, 2026 |
| K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) | Guangdong JINME Medical Technology Co., Ltd. | Oct 23, 2026 |
| K260251 | BreathCare PAP III (YH-390N) | Suzhou Yuyue Medical Technology Co., Ltd. | Oct 23, 2026 |
| K253875 | OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens | Visco Vision, Inc. | Oct 23, 2026 |
| K263421 | Veritas Shoulder System | restor3d, inc. | Oct 22, 2026 |
| K263333 | Xpert Xpress CoV-2/Flu plus | Cepheid® | Oct 22, 2026 |
| K262701 | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) | Beijing Sea Heart International Science and Technologyco.Ltd | Oct 22, 2026 |
| K262184 | GANNET® | BAAT Medical Products B.V. | Oct 22, 2026 |
| K262126 | Cerclage Wires;K-wires;Steinmann Pins | MK Medical GmbH | Oct 22, 2026 |
| K262084 | S.I.N. Instruments Kits | S.I.N. Implant System Ltda | Oct 22, 2026 |
| K261565 | FAQ™ (FAQ 411) | Foreo, Inc. | Oct 22, 2026 |
| K261295 | MultiNeO Dental Implant System | Alpha Bio Tec , Ltd. | Oct 22, 2026 |
| K260920 | Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA) | Berkeley Advanced Biomaterials | Oct 22, 2026 |
| K260686 | Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter | Zylox Medtech Co., Ltd. | Oct 22, 2026 |
| K260261 | Gravity Blood Sets with 200µm Filter | B.Braun Medical, Inc. | Oct 22, 2026 |
