| Visby Medical Men's Sexual Health Test (K251501) | Visby Medical, Inc. | 2025-10-01 |
| Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, (K252804) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 |
| PRO-DOSE System (K250083) | Nu-Rise, SA | 2025-10-01 |
| Picosecond laser device (BMPS4) (K252447) | Hebei Newangie Technology Co., Ltd. | 2025-10-01 |
| Vena MicroAngioscope™ System (K251767) | Vena Medical Holdings Corp | 2025-10-01 |
| Newclip Patient-matched instrumentation non sterile PSI (K250767) | Newclip Technics | 2025-10-01 |
| Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) (K251799) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | 2025-09-30 |
| Astrasono A3Pro Bladder Scanner (A3Pro) (K250331) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| Francisella tularensis Real-time PCR assay (K252072) | Centers for Disease Control and Prevention | 2025-09-30 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| Dexter L6 System (K251197) | Distalmotion SA | 2025-09-30 |
| IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (K251669) | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 |
| miDiagnostics HSV-1&2 CSF Test (K250050) | Midiagnostics NV | 2025-09-30 |
| Biopsy Forceps (K252722) | Fehling Instruments GmbH | 2025-09-30 |
| TigerConnect Alarm Management (K243270) | Tigerconnect | 2025-09-30 |
| Arthrex SpeedFLEX™ Implant (K251690) | Arthrex, Inc. | 2025-09-30 |
| Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (K252085) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-09-30 |
| G-BLOCK (K253236) | Graphenano Dental S.L. | 2025-09-29 |
| UltraGuideCTR® image guided soft tissue release system (K252594) | Sonex Health | 2025-09-29 |
| SureTome™ SW Sphincterotome with DomeTip (K251104) | Wilson-Cook Medical | 2025-09-29 |
| allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (K252051) | Tulavi Therapeutics, Inc. | 2025-09-29 |
| SpineAR SNAP (SyncAR Spine) (K252054) | Surgical Theater, Inc. | 2025-09-29 |
| SMART PCFD (K250023) | Disior, Ltd. | 2025-09-29 |
| Portable oxygen concentrator (JAY-1000P) (K243833) | Longfian Scitech Co., Ltd. | 2025-09-29 |
| Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (K250123) | Hager& Meisinger GmbH | 2025-09-29 |
| Paltop Dental Implant System (K243983) | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 |
| Primero Safe Access System (K252441) | South53, LLC | 2025-09-29 |
| NEW DOUBLO 2.0 (K251334) | Hironic Co., Ltd. | 2025-09-29 |
| iLet ACE Pump (K252770) | Beta Bionics, Inc. | 2025-09-29 |
| Ligence Heart (K252105) | Ligence Uab | 2025-09-26 |
| Tuned Self-Fitting Mobile App (K251208) | Tuned , Ltd. | 2025-09-26 |
| VitalStream ART Connect; VitalStream-Hemo (K251275) | Caretaker Medical | 2025-09-26 |
| Thulium Laser System (Deluxlase) (K251919) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-09-26 |
| Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K250093) | Linshom Medical, Inc. | 2025-09-26 |
| Radial Jaw 4 Pulmonary Biopsy Forceps (K252921) | Boston Scientific Corporation | 2025-09-26 |
| FUJIFILM Stiffening Wire Device (SW-2000) (K251204) | FUJIFILM Healthcare Americas Corporation | 2025-09-26 |
| Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (K251645) | Canon Medical Systems Corporation | 2025-09-26 |
| Planmed XFI (K250318) | Planmed OY | 2025-09-26 |
| Inset Reverse Total Shoulder System (K252221) | Shoulder Innovations, Inc. | 2025-09-26 |
| AUXILIARY WATER TUBE MAJ-855 (K251986) | Olympus Medical Systems Corporation | 2025-09-26 |
| Optima Coil System (Optima Packing Coil System) (K252700) | Balt USA, LLC | 2025-09-26 |
| LoFric Origo (K250659) | Wellspect AB | 2025-09-26 |
| Magnetic Surgical System (K252435) | Levita Magnetics International Corp | 2025-09-26 |
| S.I.N. Dental Implant System (K251262) | S.I.N. Implant System Ltda | 2025-09-26 |
| EnSite™ X EP System (K252013) | ABBOTT MEDICAL | 2025-09-25 |
| Stem Extension Line (U2 Total Knee System—PSA Type) (K252725) | United Orthopedic Corporation | 2025-09-25 |
| Steripath® Flow™ Blood Collection System (K251812) | Magnolia Medical Technologies | 2025-09-25 |
| Brain WMH (K251527) | Quantib B.V. | 2025-09-25 |
| RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (K251971) | Stryker Instruments | 2025-09-25 |
| Essilor® Stellest® (DEN250016) | Essilor Of America, Inc. | 2025-09-25 |
| Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced (K243785) | Covidien, LLC | 2025-09-25 |
| Single-Use Biopsy Valve (MAJ-1555) (K251997) | Olympus Medical Systems Corporation | 2025-09-25 |
| Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (K244009) | Yung Sheng Optical Co., Ltd. | 2025-09-25 |
| Pulse Oximeter (K250837) | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 |
| Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (K252063) | Wuhan Dimed Laser Technology Co., Ltd. | 2025-09-25 |
| JDEvolution Plus L and JDEvolution Plus LE (K251148) | Jdentalcare Srl | 2025-09-25 |
| Panther Fusion GI Bacterial Assay (K251868) | Hologic | 2025-09-25 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062) | Thermo Fisher Scientific | 2025-09-25 |
| EMBOTRAP III Revascularization Device (K251789) | Neuravi Limited | 2025-09-25 |
| Auxano® Wedge Fixation System (K251791) | Auxano Medical, LLC | 2025-09-25 |
| Endeavor™ Stand-Alone Cervical IBF System (K250076) | Innovasis | 2025-09-25 |
| Hi bebe super (BT-150B) (K251512) | Bistos Co., Ltd. | 2025-09-25 |
| uMR 680 (K252371) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 |
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Root canal repair materials (nRoot BP) (K251465) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703) | Boston Scientific Corporation | 2025-09-24 |
| ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (K244029) | Endorobotics Co., Ltd. | 2025-09-24 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (K250071) | Alma Lasers, Inc. | 2025-09-24 |
| t:slim X2 insulin pump with interoperable technology (K250792) | Tandem Diabetes Care, Inc. | 2025-09-24 |
| Celerity™ 20 HP Biological Indicator (K252680) | STERIS Corporation | 2025-09-24 |
| Pounce(TM) Sheath (K252227) | Surmodics,Inc. | 2025-09-24 |
| Resitu Slider 09 (RESL09) (K252183) | Resitu Medical AB | 2025-09-24 |
| ProVee Video Processing Unit (PV-003) (K251734) | Proverum Limited | 2025-09-24 |
| Digital X-Ray DentiMax Pro Imaging System (K251206) | Dentimax, Inc. | 2025-09-24 |
| MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K252689) | Imaxeon Pty, Ltd. | 2025-09-24 |
| uWS-Angio Pro (K250045) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 |
| Retraxil (K243910) | Kulzer, LLC | 2025-09-24 |
| PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (K252644) | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (K252043) | Olympus Winter & Ibe GmbH | 2025-09-23 |
| Rapid Aortic Measurements (K251987) | Ischemaview, Inc. | 2025-09-23 |
| Zenflow Spring Scope (K251140) | Zenflow, Inc. | 2025-09-23 |
| Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080) | Biolinq Incorporated | 2025-09-23 |
| Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 |
| Ion Endoluminal System (IF1000) (K252045) | Intuitive Surgical, Inc. | 2025-09-23 |
| Luminance Red Cold Sore Device (TN1927G) (K251973) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| SwiftSight-Brain (K251483) | Airs Medical, Inc. | 2025-09-23 |
| Himaging Bronchscope System (K251894) | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 |
| SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System (K251743) | Surgical Principals, Inc. | 2025-09-22 |
| Santreva™-ATK Endovascular Revasculariztion Catheter (K252315) | AngioSafe, Inc. | 2025-09-22 |
| IC-Flow™ Imaging System 2.0 (K243645) | Diagnostic Green GmbH | 2025-09-22 |
| Babio® Virus Transport Kit (Non-inactivating) (K250205) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 |
| ENDOFLATOR + (K250388) | Karl Storz SE & CO. KG | 2025-09-22 |
| KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (DEN240067) | Cytocell Limited | 2025-09-19 |
| Coated hip implants (K250450) | Medacta International S.A. | 2025-09-19 |
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (K251867) | Olympus Medical Systems Corp. | 2025-09-19 |
| Bunkerhill ECG-EF (K250649) | BunkerHill Health | 2025-09-19 |