| Guardenia (GAR-1) (K232701) | Advanced Surgical Concepts | 2023-09-29 |
| UltraFlo-R Push Button Blood Collection Set (K220458) | Innovative Medical Technologies, Inc. | 2023-09-29 |
| Boppli Infant Blood Pressure Monitor (K223873) | Pyrames, Inc. | 2023-09-29 |
| BeShape One™ Device (K231628) | Beshape Technologies , Ltd. | 2023-09-29 |
| ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (K221359) | Instrumentation Laboratory CO | 2023-09-29 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K232650) | S.M.A.I.O | 2023-09-29 |
| CeraPutty (K232299) | Meta Biomed Co., Ltd. | 2023-09-29 |
| Amulet™ Steerable Delivery Sheath (K232690) | ABBOTT MEDICAL | 2023-09-29 |
| Procise IFX (DEN210056) | Procisedx, Inc. | 2023-09-29 |
| Stat Profile Prime Plus Analyzer System (K221900) | Nova Biomedical Corporation | 2023-09-29 |
| Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (K232605) | Lesspine Innovations | 2023-09-28 |
| VeriSafe Safety sterile syringes (K231792) | Promisemed Hangzhou Meditech Co., Ltd. | 2023-09-28 |
| DNA/RNA Shield SafeCollect Saliva Collection kit (K231013) | Zymo Research | 2023-09-28 |
| BeautiLink SA (K233161) | Shofu Dental Corporation | 2023-09-28 |
| ALIGN Radial Head System (K231188) | Skeletal Dynamics, Inc. | 2023-09-28 |
| Brainomix 360 Triage LVO (K231837) | Brainomix Limited | 2023-09-28 |
| Hakon, Hakon Smart (K231901) | Medical San Indústria DE Equipamentos Médicos Ltda. | 2023-09-28 |
| Low Ejection Fraction AI-ECG Algorithm (K232699) | Anumana, Inc. | 2023-09-28 |
| IPL hair removal device (K232274) | Lumenessa Corp | 2023-09-28 |
| PIVO™ Pro Needle-free Blood Collection Device (K230865) | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-28 |
| EZSensor XHD (K232255) | Qpix Solutions, Inc. | 2023-09-27 |
| Disposable Injection Needle AF series (K230925) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 |
| VariLift®-C Interbody Fusion System (K231076) | Wenzel Spine, Inc. | 2023-09-27 |
| EVOLUTION® Hinge Knee System (K230563) | Microport Orthopedics, Inc. | 2023-09-27 |
| Talon Transseptal Sheath (K231108) | Inari Medical, Inc. | 2023-09-27 |
| VySpan™ PCT System (K232167) | Vy Spine, LLC | 2023-09-27 |
| Volta AF-Xplorer (K232616) | Volta Medical | 2023-09-27 |
| Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638) | Cepheid | 2023-09-27 |
| Micro Ace™ Advanced Micro Access System (K232609) | Merit Medical Systems, Inc. | 2023-09-27 |
| CEDIA Heroin Metabolite (6-AM) Assay (K231007) | Microgenics Corporation | 2023-09-27 |
| EndoGI S-Path Biliary Stent System (K232596) | Endogi Medical, Ltd. | 2023-09-27 |
| Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (K231363) | Hantech Medical Device Co., Ltd. | 2023-09-27 |
| Thinline Sheath Introducer (K232260) | Inneuroco, Inc. | 2023-09-27 |
| Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (K214117) | Abbott Diagnostics Technologies AS | 2023-09-27 |
| FreedomFlow Orbital Circumferential Atherectomy System (K231538) | Cardio Flow Inc., | 2023-09-27 |
| Cove Strip, OsteoCove Strip (K232668) | SeaSpine Orthopedics Corporation | 2023-09-27 |
| Invictus® Spinal Fixation System (K232275) | Alphatec Spine, Inc. | 2023-09-27 |
| Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems (K223496) | Prismatik Dentalcraft, Inc. | 2023-09-26 |
| MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (K230398) | Medcad | 2023-09-26 |
| OFIX MIS App (K230252) | Orthofix US, LLC | 2023-09-26 |
| EasyStat 300 (K220396) | Medica Corporation | 2023-09-26 |
| AVVIGO'+ Multi-Modality Guidance System (K230884) | Boston Scientific Corporation | 2023-09-26 |
| ES Series V2 (K232336) | E-Scopics | 2023-09-26 |
| ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System (K232617) | Siemens Medical Solutions USA, Inc. | 2023-09-26 |
| VasQ (DEN220026) | Laminate Medical Technologies , Ltd. | 2023-09-26 |
| Arthrex Univers Apex OptiFit Humeral Stem (K230513) | Arthrex, Inc. | 2023-09-26 |
| DEKA PHYSIQ 360 (K231971) | El.En S.P.A. | 2023-09-26 |
| Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233) | Align Technology, Inc. | 2023-09-26 |
| Access Thyroglobulin Antibody II (K213517) | Beckman Coulter, Inc. | 2023-09-26 |
| IdentiTi ALIF Interbody Systems (K232097) | Alphatec Spine, Inc. | 2023-09-25 |
| BD Texium™ Needle-Free Syringe (K231888) | Care Fusion | 2023-09-25 |
| Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (K223933) | Exactech, Inc. | 2023-09-25 |
| EndoCore (K230778) | Praxis Medical, LLC | 2023-09-25 |
| EFAI RTSUITE CT HCAP-Segmentation System (K231928) | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 |
| Cervical Spine Truss System (CSTS) (K231739) | 4Web Medical, Inc. | 2023-09-25 |
| TiLink-P SI Joint Fusion System (K230857) | SurGenTec, LLC | 2023-09-25 |
| Smileyscope System (Therapy Mode) (K230825) | Smileyscope Holding, Inc. | 2023-09-25 |
| Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K231891) | Coloplast | 2023-09-25 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| Self-Fitting hearing aids (K221052) | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 |
| PEACH 2, PEACH 2 Duo, PEACH 2 go (K231977) | Foreo, Inc. | 2023-09-25 |
| ADVIA Centaur® NT-proBNPII (PBNPII) (K220265) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 |
| Osstem Implant System (K222778) | Osstem Implant Co., Ltd. | 2023-09-23 |
| B.Light Clear Evo and B.Light Restore Evo (K223919) | Bemer Int AG | 2023-09-23 |
| Annalise Enterprise CTB Triage Trauma (K231767) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| qXR-CTR (K231149) | Qure.Ai Technologies | 2023-09-22 |
| ALFIS Vitamin D, ALFIS-3 Analyzer (K221817) | Immunostics Inc., | 2023-09-22 |
| Access CEA (K223921) | Beckman Coulter, Inc. | 2023-09-22 |
| Para-Fix External Fixation System (K230067) | New Paradigm Biomedical | 2023-09-22 |
| T-SHAPE 2 (K231092) | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 |
| FemaSeed Intratubal Insemination (K231730) | Femasys, Inc. | 2023-09-22 |
| DX. Bond V Dental Bonding Adhesive (K232978) | Sino-Dentex Co., Ltd. | 2023-09-22 |
| MicroMatrix® Flex (K230980) | Acell, Inc. | 2023-09-22 |
| Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) (K232193) | Yurob Rehabilitation Medical Co., Ltd. | 2023-09-22 |
| CATHTONG™ II PICC Catheter (K232571) | L&Z Us, Inc. | 2023-09-22 |
| Jazz (K223659) | Ai Medical AG | 2023-09-22 |
| Annalise Enterprise CTB Triage Trauma (K231384) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| VISULAS yag (K230350) | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (K220179) | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 |
| iLet® Dosing Decision Software (K232224) | Beta Bionics, Inc. | 2023-09-22 |
| Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 |
| IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 (K232183) | Shenzhen Koli Technology Co.,Ltd | 2023-09-22 |
| Nexiva™ Closed IV Catheter System with NearPort™ IV Access (K231239) | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-22 |
| CATHTONG™ II PICC Catheter (K232594) | L&Z Us, Inc. | 2023-09-22 |
| TriALTIS Spine System (K231479) | Medos International SARL | 2023-09-22 |
| UroLift 2 ATC Advanced Tissue Control System (K232558) | Neotract, Inc. | 2023-09-22 |
| Pelvic Floor Muscle Stimulator (K230767) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-09-21 |
| QEVO System (K232159) | Carl Zeiss Meditec, AG | 2023-09-21 |
| EGIS Biliary Single Bare Stent (K223354) | S&G Biotech, Inc. | 2023-09-21 |
| Smart double sides wearable breast pump, Electric bilateral breast pump (K230102) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2023-09-21 |
| Powder-Free Nitrile Examination Gloves (K223214) | Global Protection Corp. | 2023-09-21 |
| Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401) | Poly Medicure Limited | 2023-09-21 |
| Overjet Periapical Radiolucency Assist (K231678) | Overjet, Inc. | 2023-09-21 |
| Servator P Plus SALF Solution (K230193) | S.A.L.F. Spa | 2023-09-21 |
| BTL-899F (K230467) | BTL Industries, Inc. | 2023-09-21 |
| CAREMIBRAIN (K232569) | General Equipment For Medical Imaging, S.A. | 2023-09-21 |
| Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (K231248) | Edwards Lifesciencess, LLC | 2023-09-21 |
| Integrity-SI® Fusion System (K230226) | OsteoCentric Technologies | 2023-09-21 |
| Insufflator (OPTO-IFL1000) (K231342) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 |
| Cholestech LDX ™ System (K223179) | Alere San Diego, Inc. | 2023-09-20 |