| iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192) | Nextstep Arthopedix, LLC | 2026-06-05 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656) | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| Digital C-ARM with 3D (K253296) | Allengers Medical Systems Limited | 2026-06-05 |
| LUNA 3D (K253004) | Lap GmbH Laser Applikationen | 2026-06-04 |
| LumiGlam Laser System (SHE-LSP601-3) (K260690) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| Radius VSM and Accessories (K254209) | Masimo Corporation | 2026-06-04 |
| Precision S 4K Sinuscope (K253602) | Stryker Endoscopy | 2026-06-04 |
| Strauss Surgical Resection Instruments (K253020) | American Medical Endoscopy, Inc. | 2026-06-04 |
| Signature™ ONE System (K261510) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-06-04 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Dental Cone Beam Computed Tomography System (K260662) | Yofo Medical Technology Co., Ltd. | 2026-06-04 |
| Orion (K253553) | Resmed Corp | 2026-06-04 |
| Sonio Suspect (K261519) | Sonio | 2026-06-04 |
| TroKit Laparoscope Lens Wiper (K253994) | TroCare, LLC | 2026-06-04 |
| Instrument Exit Point on Touch Surgery™ Aide (K253984) | Covidien, LLC | 2026-06-04 |
| Spectra Platinum Mini (K260956) | Uzinmedicare Co., Ltd. | 2026-06-04 |
| Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575) | New York Embroidery Studio (NYES) | 2026-06-04 |
| Harmony Referral System with Harmony OCT Viewer (Octave) (K253893) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 |
| GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (K253102) | Gt Metabolic Solutions, Inc. | 2026-06-04 |
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) | DiaSorin, Inc. | 2026-06-04 |
| DEEPVESSEL Plaque (K260497) | Keya Medical Technology Co., Ltd. | 2026-06-04 |
| Upper arm electronic blood pressure monitor (XB-01) (K253124) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| HeartFocus (K260780) | Deski | 2026-06-03 |
| CustoMED Viewer (K260116) | CustoMED , Ltd. | 2026-06-03 |
| Roosin Collagen Dressing (K253974) | Roosin Medical Co., Ltd. | 2026-06-03 |
| BracePaste Prime Plus (K261840) | American Orthodontics | 2026-06-03 |
| MeRT System (K260402) | Wave Neuroscience | 2026-06-03 |
| Permatage Flowable, Settable Hemostatic Bone Paste (K261439) | Orthocon, Inc. | 2026-06-03 |
| VSP System (Titanium Palatal Splint) (K261826) | 3D Systems, Inc. | 2026-06-03 |
| BioWave BioWraps (K261522) | Biowave Corporation | 2026-06-03 |
| Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl (K260703) | S&S Glove Corporation | 2026-06-03 |
| CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (K260715) | The Beauty Tech Group, Ltd. | 2026-06-03 |
| KARL STORZ Endoscopic Accessories for Urology (K252800) | Karl Storz SE & CO. KG | 2026-06-03 |
| Straumann® ProClean™ Cassette (041.800 ; 041.801) (K260726) | Institut Straumann AG | 2026-06-03 |
| VITA Multi-Function Head Brush (TB-2343F, TB-2442F) (K260179) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026-06-03 |
| Electric Wheelchair (DF506) (K260373) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 |
| Nitrile Disposable Examination Gloves (K260806) | Vista Industries,, LLC | 2026-06-03 |
| SteriTite Container System with MediTray Products (K252854) | Case Medical, Inc. | 2026-06-03 |
| Scooter (YD-03) (K253600) | Yurob Rehabilitation Medical Co., Ltd. | 2026-06-03 |
| SIC Abutments including CAD/CAM Solutions (K252904) | Sic Invent AG | 2026-06-03 |
| Tissue Approximation System (K261484) | Tas Medical, Inc. | 2026-06-03 |
| iiSure Infusion Set (K261530) | Deka Research and Development | 2026-06-03 |
| Roosin Collagen Powder (K254034) | Roosin Medical Co., Ltd. | 2026-06-03 |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (K260571) | Life Spine, Inc. | 2026-06-02 |
| High Tone Power therapy (HiToP) (Model: HiToP PNP) (K252816) | Mohammadali Nezakati | 2026-06-02 |
| TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (K253195) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-02 |
| Inno-Port Disposable Bladed Trocar (K252532) | Taiwan Surgical Corporation | 2026-06-02 |
| DIAFIL (K261093) | DiaDent Group International | 2026-06-02 |
| Hemospray Endoscopic Hemostat (HEMO-[X]) (K253302) | Wilson-Cook Medical, Inc. | 2026-06-02 |
| FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) (K260270) | FindAir Sp. z o.o. | 2026-06-02 |
| Pectus Blu System (K261002) | Biomet Microfixation | 2026-06-02 |
| Device 300419 Strip (K260364) | Geistlich Pharma AG | 2026-06-02 |
| Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (K253507) | Orthalign, Inc. | 2026-06-02 |
| MILAN System (K253803) | Lumenis Be, Ltd. | 2026-06-02 |
| Tyto Insights for Wheeze Detection (with PCCP) (K252844) | Tyto Care , Ltd. | 2026-06-02 |
| Manual Wheelchair (LW01108) (K260642) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 |
| DB 4000 High Impact Denture Base (K260569) | Carbon, Inc. | 2026-06-02 |
| Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (K253918) | F Care Systems USA, LLC | 2026-06-02 |
| Female Culture Device; Male Culture Device; Transfer Device; Access Device (K252899) | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 |
| Cube 4D Navigation System, VirtuEye Pro (K261540) | Fiagon GmbH | 2026-06-02 |
| CorDx Tyfast COVID-19 Ag Rapid Test Rx (K253882) | CorDx, Inc. | 2026-06-01 |
| VisionAir Enhanced Stock Stent (K261541) | VisionAir Solutions | 2026-06-01 |
| VI°Port™ Liver Preservation System (K260456) | Traferox Technologies, Inc. | 2026-06-01 |
| CoLink® & CoLag® Non-Sterile Screws (K261154) | In2Bones USA, LLC | 2026-05-30 |
| Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) (K252821) | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 |
| Peak Flow Meter (PF-10(BR-PEF231)) (K252802) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| LASEmaR 1500 (K260489) | Eufoton S.R.L. | 2026-05-29 |
| Injection Needle (K260262) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 |
| Xpert PFP (K261038) | Newclip Technics | 2026-05-29 |
| Navigated LLIF Impactable Tracker (K261060) | Tyber Medical, LLC | 2026-05-29 |
| M12 Telemetry System (K252840) | Global Instrumentation, LLC | 2026-05-29 |
| HistoSonics® Planning Tool (K252947) | HistoSonics, Inc. | 2026-05-29 |
| CoSense ETCO Monitor (K253119) | Capnia, Inc. | 2026-05-29 |
| Oxygen Concentrator (OX-5A, OX-5C) (K252965) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 |
| OrthoGrid Hip AI® 4.0 (K260077) | OrthoGrid Systems, Inc. | 2026-05-29 |
| BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (K254076) | C.R. Bard, Inc. | 2026-05-29 |
| Cryo Sport 2.0 (AVA 501) (K252396) | Avanutri Equipamentos DE Saúde | 2026-05-29 |
| ZEUS Platform (FG0501US) (K252859) | iRhythm Technologies, Inc. | 2026-05-29 |
| GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (K261369) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 |
| Exceed® Biplanar Expandable Interbody System (K261159) | Spine Wave, Inc. | 2026-05-29 |
| LUNE PureHygiene (K260138) | Enamel Pure | 2026-05-29 |
| eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) (K254300) | Anker Innovations Limited | 2026-05-29 |
| Nexus DRF Digital X-ray Imaging System (K253103) | Varex Imaging Corporation | 2026-05-29 |
| Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus (K260507) | INTEROJO, Inc. | 2026-05-29 |
| ENTire IRE System (K261202) | Entire Medical , Ltd. | 2026-05-29 |
| Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (K252702) | Bioptimal International Pte. , Ltd. | 2026-05-28 |
| Arthrex Bioabsorbable PushLock Suture Anchors (K253931) | Arthrex, Inc. | 2026-05-28 |
| Ulike Clear Zero (YC10 BU) (K260895) | Guangxi Ulike Medical Technology Co., Ltd. | 2026-05-28 |
| Zimmer® Persona® Personalized Knee System (K251840) | Zimmer, Inc. | 2026-05-28 |
| STIMPOD NMS460 Nerve Stimulator (K252712) | Algiamed Technologies USA, Inc. | 2026-05-28 |
| Helio Kids; Apex P (K260295) | Motion Composites | 2026-05-28 |
| 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) | Stryker Endoscopy | 2026-05-28 |
| Disposable Endoscopic Distal Attachments (K260423) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 |
| BD BACTEC FXI Culture System (K260213) | BD Diagnostic Systems | 2026-05-28 |
| Trexon™ Monofilament Synthetic Absorbable Suture (K253530) | Medtronic | 2026-05-28 |
| BMD Titanium Spinal Fusion System (K253894) | Global Biomedica s.r.o. | 2026-05-28 |
| ANDI 2.2 (K261405) | Imeka Solutions, Inc. | 2026-05-28 |
| Bellalun 2D (VDMS-1000S) (K254092) | Vieworks Co., Ltd. | 2026-05-28 |
| Dukal Crepe Paper Sterilization Wrap (K252823) | Dukal, LLC | 2026-05-28 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |