| BAHADIR STERILIZATION CONTAINERS (K233578) | Bahadir USA, LLC | 2024-03-22 |
| FITBONE® Transport and Lengthening System (K232169) | Orthofix Srl | 2024-03-22 |
| Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K231938) | O&M Halyard, Inc. | 2024-03-22 |
| uMR Omega (K240540) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-03-22 |
| Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector (K232067) | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 |
| syngo.CT Brain Hemorrhage (K232431) | Siemens Medical Solutions USA, Inc. | 2024-03-22 |
| Digital Ultrasonic Diagnostic Imaging System (Model: F6) (K231930) | Guangdong Youkey Medical Co., Ltd. | 2024-03-22 |
| SeptAlign (K233569) | Spirair, Inc. | 2024-03-22 |
| The Vest APX System (PVAPX1) (K233441) | Baxter Healthcare Corportation | 2024-03-22 |
| STRUXXURE® MCS Anterior Cervical Plate System (K240690) | Nexxt Spine | 2024-03-22 |
| IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories (K232568) | Ipg Medical Corporation | 2024-03-21 |
| APTUS Hand Scaphoid Plates (K234062) | Medartis AG | 2024-03-21 |
| ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980) | Depuy Ireland UC | 2024-03-21 |
| RedDrop ONE (One) (K234081) | Reddrop DX | 2024-03-21 |
| N2 (K240754) | Megagen Implant Co., Ltd. | 2024-03-21 |
| DynaNail Mini Tapered Hybrid (K240530) | MedShape, Inc. | 2024-03-21 |
| Tandem Mobi insulin pump with interoperable technology (K240309) | Tandem Diabetes Care, Inc. | 2024-03-21 |
| Normatec Elite (K240122) | NormaTec Industries, LP | 2024-03-21 |
| Medical Diode Laser (Model: L2) (K240179) | Wuhan Pioon Technology Co., Ltd. | 2024-03-21 |
| Ankle Truss System (ATS) (K230088) | 4Web Medical, Inc. | 2024-03-21 |
| DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (K233665) | DePuy Synthes | 2024-03-21 |
| AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test (K234006) | Allsource Screening Solutions | 2024-03-21 |
| Reach Needle (K240253) | Aerin Medical, Inc. | 2024-03-21 |
| Electrical Stimulator System (K232439) | Gymmax Technology Shenzen Co., Ltd. | 2024-03-21 |
| accufit (K233926) | Mettler Electronics Corporation | 2024-03-21 |
| AI-Rad Companion (Pulmonary) (K233753) | Siemens Healthcare GmbH | 2024-03-21 |
| Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (K240165) | Wenzhou Longwan Medical Device Factory | 2024-03-20 |
| Tranquil-L Interbody System (K233375) | Nexus Spine, LLC | 2024-03-20 |
| V-PVP (K232125) | Vitromed GmbH | 2024-03-20 |
| BruxZir® Radiant (K240574) | Prismatik Dentalcraft, Inc. | 2024-03-20 |
| SMARTXIDE PRO (K240537) | El.En S.P.A. | 2024-03-20 |
| Peak Universal Bond (K240743) | Ultradent Products, Inc. | 2024-03-20 |
| Straumann® BLC and TLC Implants - Line extension (K234049) | Institut Straumann AG | 2024-03-20 |
| EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090) | Surgvision GmbH | 2024-03-20 |
| Access Ferritin (K234052) | Beckman Coulter, Inc. | 2024-03-20 |
| BEED 2,5, BEED 3,8 (K233002) | Excelsior Resources, LLC | 2024-03-20 |
| NuVasive AttraX Scaffold (K240507) | Nuvasive, Inc. | 2024-03-20 |
| Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O (K234130) | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| PATHFAST®hs-cTnI-II (K231974) | Phc Corporation | 2024-03-20 |
| Automatic Registration (K234047) | Brainlab AG | 2024-03-20 |
| Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) (K233901) | Shenzhen Desida Technology Co., Ltd. | 2024-03-20 |
| InMode RF System (K233642) | InMode , Ltd. | 2024-03-20 |
| Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) (K232654) | Nephron Nitrile, LLC | 2024-03-20 |
| Medical Surgical Mask (K231719) | Azur Medical Company, Inc. | 2024-03-19 |
| Pre-Sintered Zirconia Coloring Liquid (K232682) | Chengdu Besmile Medical Technology Co., Ltd. | 2024-03-19 |
| ARX Viral Transport Media Collection and Transport System (K231843) | Arx Sciences, Inc. | 2024-03-19 |
| Blood Pressure Monitor (K233146) | Shenzhen Jamr Technology Co., Ltd. | 2024-03-19 |
| Amydi-med Disposable Non-invasive EEG electrodes (K240668) | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024-03-19 |
| MATRIX HA PEEK Cervical IBF System (K232619) | Sapphire Medical Group | 2024-03-19 |
| HWJECT Auto-disable syringe (K234024) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024-03-19 |
| Disposable Dual Action Tissue Closure Device (K233772) | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 |
| Real Intelligence™ CORI™ (K240139) | Blue Belt Technologies, Inc. | 2024-03-18 |
| nCommand Lite System (K233660) | Ionic Health | 2024-03-18 |
| X-Clever (ASHK100G) (K233599) | Lg Electronics.Inc | 2024-03-18 |
| uNion® MAX Cervical Plate System (K240515) | Ulrich Medical USA, Inc. | 2024-03-18 |
| CORIOGRAPH Knee Pre-Op Plan (K240113) | Smith & Nephew, Inc. | 2024-03-18 |
| Meriglu Topical Skin Adhesive (K230981) | M/s. Meril Endo Surgery Private Limited. | 2024-03-16 |
| RESPONDER® Polysaccharide Hemostat (K240454) | Starch Medical, Inc. | 2024-03-15 |
| Xprecia Prime Coagulation System (K230802) | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| Intensity Pulsed Light Therapy System (K233307) | Beijing Adss Development Co., Ltd. | 2024-03-15 |
| ivWatch® Model 400 (K233881) | Ivwatch, LLC | 2024-03-15 |
| MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (K240441) | Depuy Mitek | 2024-03-15 |
| CINA-ASPECTS (K233342) | Avicenna.Ai | 2024-03-15 |
| APRO 55 Catheter (K234115) | Alembic, LLC | 2024-03-15 |
| PICOANDY (Q-Switched Nd:YAG Laser) (K234104) | Wontech Co., Ltd. | 2024-03-15 |
| CIARTIC Move (VB10) (K233748) | Siemens Medical Solutions USA, Inc. | 2024-03-15 |
| Otoport Pro (K240430) | Otodynamics, Ltd. | 2024-03-15 |
| Vital™ Spinal Fixation System (K240539) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-03-15 |
| BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986) | Becton, Dickinson and Company | 2024-03-15 |
| TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (K231856) | Medexel Co.,Ltd | 2024-03-15 |
| Light Cure Composite (K240112) | Sincera Technology (Changchun) Co., Ltd. | 2024-03-15 |
| Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) (K233799) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2024-03-15 |
| Endorail (K232327) | Endostart S.R.L. | 2024-03-15 |
| Concha Sol Hearing Aids (CL-1001) (K233747) | Concha Labs | 2024-03-15 |
| Aventus Thrombectomy System (IM-2001/IM-0002) (K240117) | Inquis Medical | 2024-03-15 |
| FORMA Composite (Shade A3D) (K240694) | Ultradent Products, Inc. | 2024-03-15 |
| STARband 3D (K240466) | Orthomerica Products, Inc. | 2024-03-15 |
| Nouvo Safety Set (K232234) | Poly Medicure Limited | 2024-03-15 |
| 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K233814) | 3M Company | 2024-03-15 |
| NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (K232803) | Nxstage Medical, Inc. | 2024-03-14 |
| QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (K231850) | Globus Medical, Inc. | 2024-03-14 |
| Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (K233542) | Stryker Leibinger GmbH & Co KG | 2024-03-14 |
| Myriad SPECTRA Light Source (K232567) | Nico Corporation | 2024-03-14 |
| SpermAlign Sperm Separation Device (K232980) | Cytoswim, Ltd. | 2024-03-14 |
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610) | Intuitive Surgical, Inc. | 2024-03-14 |
| LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (K233853) | Philips Medical Systems Nederland B.V. | 2024-03-14 |
| CloudPoint FastDesign Chairside (K231529) | Prismatik Dentalcraft, Inc. | 2024-03-14 |
| hekaDrill (K233958) | Zethon, Ltd. | 2024-03-14 |
| Define RF Microneedling System (K232301) | Aesthetic Management Partners | 2024-03-14 |
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| Edison System (K233466) | HistoSonics, Inc. | 2024-03-13 |
| CAS-One IR (K232022) | Cascination AG | 2024-03-13 |
| CERAMENT G (K234008) | Bonesupport AB | 2024-03-13 |
| CINA-iPE (K233968) | Avicenna.Ai | 2024-03-13 |
| BioPoly Radial Head Implant (K233592) | BioPoly, LLC | 2024-03-13 |
| ACCORD Cable System (K233949) | Smith & Nephew, Inc. | 2024-03-13 |
| DEKA ACE Pump System (K233952) | Deka Research and Development | 2024-03-13 |
| ICEfx Cryoablation System (FPRCH8000-02) (K234002) | Boston Scientific | 2024-03-13 |
| Hygeia Express Powered Breast Pump (K233136) | Hygeia II Medical Group, Inc. | 2024-03-13 |
| MRCP+ version 2 (MRCP+ v2) (K233930) | Perspectum | 2024-03-13 |