| Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay (K252336) | Diazyme Laboratories, Inc. | 2026-04-24 |
| INDIGO® Aspiration System – INDIGO Link (K260599) | Penumbra, Inc. | 2026-04-24 |
| EdgeFlow Gel Pad (K252337) | Edgecare, Inc. | 2026-04-24 |
| I.T.S. PRS Phoenix II (K260054) | I.T.S. GmbH | 2026-04-24 |
| FloPatch FP120 (K252810) | Flosonics Medical | 2026-04-24 |
| Dilation Balloon Catheter (K253832) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| AUTOBAHN™ Nailing System (K261043) | Globus Medical, Inc. | 2026-04-24 |
| EPORE® XO cup system (K252451) | Implantcast GmbH | 2026-04-24 |
| Knee+ (K253805) | Pixee Medical S.A.S. | 2026-04-24 |
| Elecsys Calcitonin (K252431) | Roche Diagnostics GmbH | 2026-04-24 |
| Visualized Access and Delivery Catheter; PB Digital Controller (K252492) | Micro-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| Control-IQ+ technology (K260429) | Tandem Diabetes Care, Inc. | 2026-04-24 |
| SMARTeZ™ Elastomeric Infusion Pump (RS series) (K250234) | Epic Medical Pte. , Ltd. | 2026-04-24 |
| Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute (K261008) | Stryker Spine | 2026-04-24 |
| POYA 3.5mm Medial Proximal Tibia System (K260228) | Bonebridge AG | 2026-04-24 |
| Compression Therapy Device (LGT-2202DVT) (K250242) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 |
| °M Warmer System with °M Station (K260988) | Mequ A/S | 2026-04-24 |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) (K260982) | Applied Medical Resources Corporation | 2026-04-24 |
| Amplatzer TorqVue Delivery System (K260993) | Abbott | 2026-04-24 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| LungPoint Virtual Bronchoscopic Navigation (VBN) Software (K260009) | Broncus Medical, Inc. | 2026-04-24 |
| CCI PACS VIEWER (PACS-US-001) (K254237) | CliniComp, Intl. | 2026-04-23 |
| Lunit INSIGHT MMG (v1.1.10) (K260320) | Lunit, Inc. | 2026-04-23 |
| 0.55T 12Ch Breast Coil (K260947) | Neocoil, LLC | 2026-04-23 |
| Introducer Sheath Set (K254248) | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) (K252341) | Olympus Medical Systems Corp. | 2026-04-23 |
| OptiMap Catheter - 60mm (OPTI-CATH2-60) (K261012) | Cortex, Inc. | 2026-04-23 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Tula Tympanostomy Tube Delivery Device (K252436) | Tusker Medical, Inc. | 2026-04-23 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| DS Core CBCT Anatomy (K260785) | Dentsply Sirona | 2026-04-23 |
| ProBeam 360 Proton Therapy System v3.0 (K252815) | Varian Medical Systems, Inc. | 2026-04-23 |
| OxyGo Portable Oxygen Concentrator (1400-7000) (K252407) | Mv Life, LLC | 2026-04-23 |
| Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (K260152) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (K252389) | Smwmed, Inc. | 2026-04-23 |
| NeuroBlate System (K260976) | Monteris Medical | 2026-04-23 |
| Liberant™ RX Aspiration Catheter (K253589) | Medtronic Interventional Vascular, Inc. | 2026-04-23 |
| myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) (K253256) | Otto Bock Healthcare Products GmbH | 2026-04-22 |
| LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (K260150) | NOOANCE | 2026-04-22 |
| uOmnispace.MR (K253077) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 |
| Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) (K260239) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 |
| VANISH PRO (K253765) | Ddc Technologies, Inc. | 2026-04-22 |
| Mobility Scooter (X-12, X-14, X-17) (K260237) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 |
| corra™ cervical plating system (K260570) | Carlsmed, Inc. | 2026-04-22 |
| Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) (K252306) | Steritec Products | 2026-04-22 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (K253163) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (K253230) | Erbe Elektromedizin GmbH | 2026-04-22 |
| Korotkoff sound blood pressure monitor (K253982) | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| BosCATH Support Catheter (K254046) | Sonorous NV, Inc. | 2026-04-21 |
| EvoEndo Single-Use Endoscopy System (K260573) | EvoEndo, Inc. | 2026-04-21 |
| Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921) | Tigon Medical | 2026-04-21 |
| IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) (K260518) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2026-04-21 |
| RhythmStar System (SL) (K250793) | RhythMedix, LLC | 2026-04-21 |
| CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216) | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447) | bioMérieux SA | 2026-04-21 |
| Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (K253003) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| Luminoah FLOW™ Enteral Nutrition System (K253558) | Luminoah | 2026-04-20 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| xStep (xStep) (K253638) | Spinex, Inc. | 2026-04-20 |
| Q-Switched Nd: YAG Laser System (Glamor Q) (K260153) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| Folliscan (K252332) | Mim Fertility | 2026-04-20 |
| SAGI Cervical Cage System (K253213) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| Lunar Astra (K252718) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 |
| SmartSurgN Visualization System (K242163) | SmartsurgN, Inc. | 2026-04-20 |
| Power Wheelchair (N5919 series) (K253806) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 |
| DYNEX® External Fixation Systems (K260900) | Vilex, LLC | 2026-04-17 |
| Dura-Arch (K261261) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| TITAN Nail; APTUS K-Wire System (K260934) | Medartis AG | 2026-04-17 |
| Wovyn Depth Electrode (K253970) | Sensomedical Labs, Ltd. | 2026-04-17 |
| Neonav ECG Tip Location System (K260929) | Navi Medical Technologies | 2026-04-17 |
| Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279) | Chirana T.Injecta,A.S. | 2026-04-17 |
| PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) (K252334) | Pontemedag | 2026-04-17 |
| EdgeFlow UW20 (K252237) | Edgecare, Inc. | 2026-04-17 |
| XplantR Explant Tool (DEN250033) | Hjarta Care, LLC | 2026-04-17 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Novasight Hybrid System (K252945) | Conavi Medical, Inc. | 2026-04-17 |
| Edwards eSheath+ introducer set (K254279) | Edwards Lifesciences | 2026-04-17 |
| MTS Gepotidacin 0.016-256 µg/mL (K260696) | Liofilchem s.r.l. | 2026-04-17 |
| ORIO-3D Cage System (K253260) | SpineCraft | 2026-04-16 |
| Freedom DS™ Decompression System (K253523) | Spinal Simplicity | 2026-04-16 |
| Hot Pink Pad Warming System (K260903) | Xodus Medical, Inc. | 2026-04-16 |
| Zenith Micro Guidewire (K252317) | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| ClearTip TBNA Type (K251478) | Finemedix Co., Ltd. | 2026-04-16 |
| Julva Velvé Water-Based Personal Lubricant (K254101) | Golden Isles Medical, Inc. | 2026-04-16 |
| DESS Dental Smart Solutions (K253804) | Terrats Medical SL | 2026-04-16 |
| Next Generation 088 Catheter (K254223) | Balt USA, LLC | 2026-04-16 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, (K253892) | Strauss Surgical USA | 2026-04-16 |
| Enso for Migraine (K254216) | Hinge Health, Inc. | 2026-04-16 |
| Insufflator (OPTO-IFL1000) (K252318) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 |
| Redermo Wound Matrix (K260020) | Beijing Kreate Medical Co., Ltd. | 2026-04-16 |
| High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube (K253048) | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 |
| Verisafe Safety Sterile Needles (SSN) (K254273) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| ARx® SAI Implant System (K254274) | Life Spine, Inc. | 2026-04-16 |
| Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) (K253537) | Bright Uro, Inc. | 2026-04-16 |
| Foundation Surgical Navigated Lateral Disc Prep Instruments (K260011) | Foundation Surgical Group, Inc. | 2026-04-16 |
| uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (K253170) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-16 |
| Endoflux™ Biliary & Pancreatic Stent Sets (K251658) | Medi-Globe GmbH | 2026-04-16 |
| Uni-C Cervical Cage System (K252774) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |