| Zamenix™ P (K253505) | Roen Surgical, Inc. | 2026-08-07 |
| Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702) | Intuitive Surgical, Inc. | 2026-08-07 |
| Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) (K251544) | Lakong Medical Devices Co., Ltd. | 2026-08-07 |
| BUM Oil (K261905) | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 |
| mdprostate (K252571) | Mediaire GmbH | 2026-08-07 |
| Mistral-Air® Warming System (K261437) | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 |
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Metrix COVID Test; Metrix COVID Test Pro (K253453) | Aptitude Medical Systems, Inc. | 2026-08-07 |
| Xpert Hemorrhagic Fever (K261362) | Cepheid | 2026-08-07 |
| Aperio GT 450 DX; Aperio GT 180 DX (K253554) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
| Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (K261028) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 |
| Aperio iQC DX Software (K253561) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
| Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) (K260933) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 |
| LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (K261601) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 |
| PacTemp Automix NE (K261937) | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 |
| Arthrex Bioabsorbable PushLock Suture Anchors (K262357) | Arthrex, Inc. | 2026-08-07 |
| Venue Go (K261668) | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 |
| Freedom Total Knee System (E-Poly Tibial Liners) (K261563) | Maxx Orthopedics, Inc. | 2026-08-07 |
| EW10-EC02 Endoscopy Support Program (K260567) | Fujifilm Corporation | 2026-08-07 |
| Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (K253999) | Nobel Biocare AB | 2026-08-06 |
| Overjet Multi-Image Caries and Charting Assist (K261059) | Overjet, Inc. | 2026-08-06 |
| Megalodon Dynamic Compression System (K261121) | Paragon 28, Inc. | 2026-08-06 |
| Aristotle Mini Guidewire (K260223) | Scientia Vascular, Inc. | 2026-08-06 |
| Telemetry Monitor (iT30, iT50) (K251508) | Edan Instruments, Inc. | 2026-08-06 |
| Manual Wheelchair (H008, PCK7) (K261571) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 |
| Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) (K253469) | Mozarc Medical Us, LLC | 2026-08-06 |
| Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898) | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 |
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
| CAD - Lower GI (EC07-01) (K252853) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 |
| Huahong Sharps Container (HHR-I, HHR-II) (K260845) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 |
| Transurethral Catheter Safety Valve (TUCSV) (80050) (K260919) | Class Medical , Ltd. | 2026-08-05 |
| Ruthinium Disc (K261456) | Dental Manufacturing S.p.A. | 2026-08-05 |
| pVasc Net Mechanical Thrombectomy Device (K254211) | Vesalio, Inc. | 2026-08-05 |
| Leksell® Vantage Stereotactic System (K261932) | Elekta Solutions AB | 2026-08-05 |
| NaturaJel™ Oral Wound Care Kit (K260120) | HCS Innovation, LLC | 2026-08-05 |
| Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (K260737) | Convatec | 2026-08-05 |
| Rusch Latex Gold Foley Catheter (K262056) | Teleflex Medical Sdn. Bhd. | 2026-08-05 |
| GFS - Sterile Screws and Top Hat (K253858) | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| Concentriq AP-Dx (K261380) | Proscia, Inc. | 2026-08-05 |
| OMNI Ultra Surgical System (1-110) (K253760) | Sight Sciences, Inc. | 2026-08-04 |
| LED Light Therapy Masks (PE748, PE749, PE756) (K261496) | Duplex International Trading Limited | 2026-08-04 |
| LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) (K261851) | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 |
| Marrow Marxman (K260572) | Medimetrix, LLC | 2026-08-04 |
| Vertex™ Thrombectomy System (K261523) | Jupiter Endovascular | 2026-08-04 |
| TRIVANCE™ Hip Stem (K254043) | Globus Medical, Inc. | 2026-08-04 |
| RealGUIDE (K253902) | 3DIEMME SRL | 2026-08-04 |
| Alturion Series Diagnostic Ultrasound System (K262311) | Philips Ultrasound, LLC | 2026-08-04 |
| VueJect® Ultrasound Enhancing Agent Delivery System (K262115) | ACIST Medical Systems, Inc. | 2026-08-03 |
| Halcyon, Ethos Radiotherapy System (5.0) (K261856) | Varian Medical Systems, Inc. | 2026-08-03 |
| Grappler Suture Anchor System (K262047) | Paragon 28, Inc. | 2026-08-03 |
| Eve (K260381) | Wandercraft SAS | 2026-08-03 |
| PuraStat GI (K261503) | 3-D Matrix, Inc. | 2026-08-03 |
| PuraStat-RM (K261504) | 3-D Matrix, Inc. | 2026-08-03 |
| SABER-XA System (K261408) | Elevation Spine | 2026-08-03 |
| XLITE (K260236) | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 |
| I-Genius (100019400) (K261331) | Esaote, S.p.A. | 2026-07-31 |
| 0909FCE, 0909FCE-HS (K253800) | Rayence Co., Ltd. | 2026-07-31 |
| SnØreNegatØr (K261912) | DnB Innovations, LLC | 2026-07-31 |
| Vertiwedge® Intraosseous System (K261810) | Foundation Surgical Group | 2026-07-31 |
| Affinity (K253835) | Hermes Medical Solutions AB | 2026-07-31 |
| ZSAlign Cervical Interbody System (K261451) | ZSFab, Inc. | 2026-07-31 |
| WatchPAT SW (K254042) | Itamar Medical , Ltd. | 2026-07-31 |
| Interwedge® Standalone Lateral (K261809) | Foundation Surgical Group | 2026-07-31 |
| Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) (K261494) | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K261183) | Olympus Medical Systems Corporation | 2026-07-31 |
| MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (K260852) | Siemens Healthineers AG | 2026-07-31 |
| Shield System (Siemens 30x40) (K260607) | Radiaction , Ltd. | 2026-07-31 |
| UniPearls® Embolic Microspheres (K252812) | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| da Vinci Surgical System, Model IS5000 (K261824) | Intuitive Surgical, Inc. | 2026-07-31 |
| Angled Screwdriver MED (M-SD090) (K253655) | W&H Dentalwerk Bürmoos GmbH | 2026-07-31 |
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251) | Globus Medical, Inc. | 2026-07-31 |
| LightStim for Wrinkles (1984); LightStim for Acne (2038) (K261482) | Led Intellectual Properties, LLC | 2026-07-31 |
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| xvision Spine system (K261854) | Augmedics, Ltd. | 2026-07-31 |
| NanoCeram Resin (K262681) | 3BFAB TEKNOLOJI A.S. | 2026-07-31 |
| Hearing Aid Feature (K261187) | Samsung Electronics Co., Ltd. | 2026-07-31 |
| Flexitouch® Plus Advanced Pneumatic Compression System (K253555) | Tactile Medical | 2026-07-31 |
| Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (K262253) | Orthalign, Inc. | 2026-07-31 |
| Motivista (CT-155) (K254038) | Click Therapeutics, Inc. | 2026-07-30 |
| PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (K261389) | Salter Labs | 2026-07-30 |
| dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T (K262330) | Philips Medical Systems Nederland B.V. | 2026-07-30 |
| SMARTVERTIGO™ Vestibular Assessment System (K260566) | VertigoDx, Inc. | 2026-07-30 |
| TnR Cranial Implant (K251959) | T&R BIOFAB CO., Ltd. | 2026-07-30 |
| neXus Ultrasonic Surgical Aspirator System (K261448) | Misonix, LLC | 2026-07-30 |
| Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (K261410) | Suite 201, National Innovation Centre | 2026-07-30 |
| AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (K262369) | Stryker Endoscopy | 2026-07-30 |
| Obsidian® Press Over Zirconia (K262239) | Prismatik Dentalcraft, Inc. | 2026-07-30 |
| cmAngio® V2.0 (K260980) | Curemetrix, Inc. | 2026-07-30 |
| Sync AV II Temporary Pacing Catheter (K252042) | Swift Sync, Inc. | 2026-07-30 |
| SmartGuide Disposable Guides and Grids (K260161) | UC-CARE , Ltd. | 2026-07-30 |
| LOGIQ Focus (K261835) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 |
| SeptAlign (SPLN001) (K260620) | Spirair, Inc. | 2026-07-30 |
| Handheld Ultrasound Scanner (K261288) | IMGFAX CO., LTD. | 2026-07-30 |
| Arthrex Radial Head Replacement System (K260624) | Arthrex, Inc. | 2026-07-30 |
| CPS Locator 3D Plus Delivery Catheter (K261766) | CenterPoint Systems, LLC | 2026-07-29 |
| Cleerly Plaque (K261210) | Cleerly, Inc. | 2026-07-29 |
| Profoject™ Dual-Safety Pen Needles (K261829) | CMT Health PTE., Ltd. | 2026-07-29 |
| Suture Button Repair System (K261770) | Skeletal Dynamics, Inc. | 2026-07-29 |
| SSPC NXT Delivery Catheter (K262240) | CenterPoint Systems, LLC | 2026-07-29 |