| JAZZ Spinal System (K252437) | Implanet | 2025-08-28 |
| Definium Tempo Select (K250788) | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| JARVIS Glenoid Reverse Shoulder Prosthesis (K252411) | FH Industrie | 2025-08-28 |
| Medical Gas Analyzer (AG200) (K250148) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965) | Alphatec Spine, Inc. | 2025-08-28 |
| truFlex (K251594) | Syrma Johari Medtech Limited | 2025-08-28 |
| CT:VQ (K251484) | 4Dmedical Limited | 2025-08-28 |
| SmartPilot YpsoMate NS-A2.25 (K243901) | Ypsomed AG | 2025-08-28 |
| Vital Signs (K243687) | Oxehealth Limited | 2025-08-27 |
| Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) (K250625) | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 |
| Phoenix Sinus Tarsi Stent System (K251382) | Astra Orthomed, Inc. | 2025-08-27 |
| QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) | Fysicon BV | 2025-08-27 |
| KnoxFog Anti-fogging Device (K251068) | Uv One Hygienics, Inc. | 2025-08-27 |
| Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (K251752) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 |
| CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 |
| Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (K251637) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 |
| ELID (Endoscopic Less Invasive Decompression) System (K243774) | Lesspine Innovations | 2025-08-27 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716) | Basic Medical Technology, Inc. | 2025-08-27 |
| Additively Manufactured Aligner Resin (K251415) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-08-27 |
| Fetal & Maternal Monitor (F15A, F15A Air) (K241882) | Edan Instruments, Inc. | 2025-08-27 |
| VistaSoft 4.0 and VisionX 4.0 (K250947) | Durr Dental SE | 2025-08-27 |
| QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080) | QIAGEN GmbH | 2025-08-27 |
| Dermalage (K243166) | Infection Elimination Solutions, LLC | 2025-08-27 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K252419) | Atraverse Medical, Inc. | 2025-08-27 |
| Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (K250049) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 |
| Rapid DeltaFuse (K252526) | Ischemaview, Inc. | 2025-08-26 |
| Ultra-Fast Vitri; Ultra-Fast Warm (K251305) | Kitazato Corporation | 2025-08-26 |
| Brainomix 360 Triage Stroke (K251983) | Brainomix Limited | 2025-08-26 |
| Heager Medical Laser Family (Sabrina/Adolf) (K250261) | Heager GmbH | 2025-08-26 |
| X-Wire Guidewire (K244061) | Imperative Care, Inc. | 2025-08-26 |
| PRO Pen Microneedling System (6883) (K243800) | Dermalogica, LLC | 2025-08-25 |
| NeuroEars-Anna™ (K243709) | Neuroears, Inc. | 2025-08-25 |
| Neurovascular Insight V1.0 (K243680) | Olea Medical S.A.S. | 2025-08-25 |
| Motor and Apex Module (MaAM) (K251811) | Dentsply Sirona, Inc. | 2025-08-25 |
| NobelZygoma TiUltra Implant system (K243834) | Nobel Biocare AB | 2025-08-25 |
| Sparrow Ascent (K251246) | Spark Biomedical, Inc. | 2025-08-25 |
| Quantra QStat Cartridge (K251404) | Hemosonics, LLC | 2025-08-25 |
| DenMat Multilayered Zirconia Disc (K251593) | Denmat Holding, LLC | 2025-08-25 |
| CRYOcheck Chromogenic Factor VIII (K251440) | Precision Biologic, Inc. | 2025-08-25 |
| Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634) | Maxx Orthopedics, Inc. | 2025-08-25 |
| GBrain MRI (K252362) | Galileo Cds, Inc. | 2025-08-22 |
| CPS Locator 3D Delivery Catheter (K250147) | Centerpoint Systems | 2025-08-22 |
| Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec (K243660) | Cardinalhealth | 2025-08-22 |
| CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (K251828) | Cerenovus, Inc. | 2025-08-22 |
| MammoScreen BD (K243685) | Therapixel | 2025-08-22 |
| CoraForce Microcatheter, CoraFlex Microcatheter (K251277) | Reflow Medical, Inc. | 2025-08-22 |
| PROMO (K251443) | DRGEM Corporation | 2025-08-22 |
| Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) (K251192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-22 |
| One-Fil Putty Injectable (K251884) | Mediclus Co., Ltd. | 2025-08-22 |
| Stem Extension Line (USTAR II System) (K252303) | United Orthopedic Corporation | 2025-08-22 |
| CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (K251604) | Access Bio, Inc. | 2025-08-22 |
| CARTO™ 3 EP Navigation System V8.1 (K252302) | Biosense Webster, Inc. | 2025-08-22 |
| EnDrive (EnDriveUS) (K243692) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 |
| Origin™ (K243965) | Nerv Technology Inc. (D.B.A.) Fluidai Medical | 2025-08-21 |
| InSee (K241152) | Tidal Medical Technologies, LLC | 2025-08-21 |
| ClearTip FNA and FNB Types (K250994) | Finemedix Co., Ltd. | 2025-08-21 |
| LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588) | Shenzhen Fittop Health Technology Co., Ltd. | 2025-08-21 |
| Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) (K250784) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-08-21 |
| Vista OS, Vista AI Scan, RTHawk (K251029) | Vista AI, Inc. | 2025-08-21 |
| MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (K251647) | Dentsply Sirona, Inc. | 2025-08-21 |
| Portable Oxygen Concentrator (JM-P50A) (K251130) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 |
| Treace Medical Concepts (TMC) Implant Fixation System (K251135) | Treace Medical Concepts | 2025-08-21 |
| The Acumed Wrist Fixation System - 2.4mm Screws (K252356) | Acumed, LLC | 2025-08-21 |
| VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579) | bioMerieux, Inc. | 2025-08-21 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid (K252244) | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| Fine Osteotomy™ (K250923) | Bodycad Laboratories, Inc. | 2025-08-21 |
| T1D1 (K252104) | Comerge AG | 2025-08-20 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K251481) | Siemens Medical Solutions USA, Inc. | 2025-08-20 |
| Methinks CTA Stroke (K251590) | Methinks Software, S.L | 2025-08-20 |
| T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400) | Stryker GmbH | 2025-08-20 |
| Salix Coronary Plaque (V1.0.0) (K251837) | Artrya Limited | 2025-08-20 |
| EndoFix™Tissue Fixation System (K251229) | Softac Medical Technologies | 2025-08-20 |
| IPD Dental Implant Abutments (K251471) | Implant Protesis Dental 2004, S.L. | 2025-08-20 |
| LOCATOR® Angled Abutment (K250721) | Zest Anchors, LLC | 2025-08-20 |
| Remanufactured EndoWrist Cobra Grasper (420190) (K250417) | Rebotix | 2025-08-20 |
| MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (K251580) | Liofilchem s.r.l. | 2025-08-20 |
| Wearable Breast Pump (Model W6) (K250383) | Shenzhen TPH Technology Co., Ltd. | 2025-08-20 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804) | Beckman Coulter, Inc. | 2025-08-20 |
| Delphi-MD System (DEN250002) | Quantalx Neuroscience, Ltd. | 2025-08-20 |
| Distal Xtremities System (K252061) | TriMed, Inc. | 2025-08-20 |
| WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (K251563) | Wondfo USA Co, Ltd. | 2025-08-20 |
| Remanufactured EndoWrist Tenaculum Forceps (420207) (K250539) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Long Tip Forceps (420048) (K250387) | Rebotix | 2025-08-19 |
| Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (K250313) | Harps Europe Manufacturing GmbH | 2025-08-19 |
| Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (K252316) | Venclose, Inc. | 2025-08-19 |
| OSSIOfiber® Interference Screw (K252022) | OSSIO , Ltd. | 2025-08-19 |
| Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (K243713) | Agnes Medical Co., Ltd. | 2025-08-19 |
| Remanufactured EndoWrist Cadiere Forceps (420049) (K250399) | Rebotix | 2025-08-19 |
| Neodent Implant System - Zirconia Implant System (K250271) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 |
| ANTHEM® Fracture System (K251161) | Globus Medical, Inc. | 2025-08-18 |
| Apollo TMS Therapy System (K243539) | Mag & More GmbH | 2025-08-18 |
| PnueAira (PNCU-01) (K251086) | Biotab, LLC | 2025-08-18 |
| Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (K243604) | O&M Halyard, Inc. | 2025-08-18 |
| Evolution Spine Navigation Instruments (K250167) | Evolution Spine | 2025-08-18 |
| OsteoCentric® UnifiMI® TCS Plating System (K251913) | OsteoCentric Technologies | 2025-08-16 |
| CHLOE BLAST (K243851) | Fairtility , Ltd. | 2025-08-15 |
| AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259) | Assure Tech., LLC | 2025-08-15 |
| Zio® monitor (DFG0001) (K243650) | iRhythm Technologies, Inc. | 2025-08-15 |
| Helios Dermal Scaffold (K250397) | Helios Biomedical, Inc. | 2025-08-15 |
| JMS CAVEO A.V. Fistula Needle Set (K251877) | JMS North America Corporation | 2025-08-15 |