| iHealth COVID-19 Antigen Rapid Test (K233842) | Ihealth Labs, Inc. | 2024-05-31 |
| Deep TMS System (K222196) | Brainsway , Ltd. | 2024-05-31 |
| S.I.N. Dental Implant System (K232821) | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-05-31 |
| Fixtemp® C&B 4:1 (K241226) | Dreve Denatmid GmbH | 2024-05-31 |
| °M Warmer System (K232107) | Mequ A/S | 2024-05-31 |
| Blood Pressure Monitor (TMB-2296-BT) (K240254) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-05-31 |
| Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248) | Spectrum Medical S.R.L. | 2024-05-31 |
| BroncTru™ Transbronchial Access Tool (K232601) | Broncus Medical, Inc. | 2024-05-31 |
| Mimics Enlight CMF (K223427) | Materialise NV | 2024-05-31 |
| LFR-260 (K233295) | Evolution Optiks Limited | 2024-05-31 |
| Anti-bacterial bandage (K232333) | Jinhua Jingdi Medical Supplies Co., Ltd. | 2024-05-31 |
| QIAstat-Dx Gastrointestinal Panel 2 (K220062) | QIAGEN GmbH | 2024-05-31 |
| Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (K232943) | Smiths Medical Asd, Inc. | 2024-05-31 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (K241194) | Biofire Diagnostics, LLC | 2024-05-30 |
| Revolution External Plating System (K233025) | New Standard Device Dba Metalogix | 2024-05-30 |
| Sunsphere (K232934) | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 |
| SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (K241289) | Maine Molecular Quality Controls, Inc. | 2024-05-30 |
| SofWave System (K240687) | Sofwave Medical, Ltd. | 2024-05-30 |
| The Circadia C200 System (K234003) | Circadia Technologies, Ltd. | 2024-05-30 |
| Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter (K232505) | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-05-30 |
| Freedom Wrist Arthroplasty System (K233674) | Ascension Orthopedics, Inc. | 2024-05-30 |
| aetherSlide (K233126) | Aetherai Co., Ltd. | 2024-05-30 |
| Spectrum Spine Cervical Cage System (K240838) | Spectrum Spine, Inc. | 2024-05-30 |
| NET Recovery Corp/NET Device (K233166) | Net Recovery | 2024-05-29 |
| EasyScreen Gastrointestinal Parasite Detection Kit (K232672) | Genetic Signatures Limited | 2024-05-29 |
| SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) (K241207) | Devoro Medical, Inc. | 2024-05-29 |
| PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K241190) | Poonglim Pharmatech, Inc. | 2024-05-29 |
| Lingo Glucose System (K233655) | Abbott | 2024-05-29 |
| AltiVate Reverse® Glenoid (K233481) | Encore Medical L.P. | 2024-05-29 |
| EK Digital Abutments (K233389) | Hiossen, Inc. | 2024-05-29 |
| Temperature Sensor Probe (ABL-18TP20) (K240784) | Varian Medical Systems, Inc. | 2024-05-29 |
| LINK(TM) External Fixator (K240049) | Metric Medical Devices, Inc. | 2024-05-29 |
| Arthrex TightRope II (K241235) | Arthrex, Inc. | 2024-05-29 |
| SmartAdjust(TM) technology (K232741) | Insulet Corporation | 2024-05-29 |
| InnoVoyce VYLO (K240159) | Innovoyce | 2024-05-29 |
| PILLAR SA Ti Spacer System (82-XXX) (K240749) | Orthofix, Inc. | 2024-05-28 |
| EVOLVE Nitric Oxide Delivery System (K240410) | Malinckrodt Manufacturing, LLC | 2024-05-28 |
| SpiroSphere, SpiroSphereECG, CardioSphere (K223629) | Eresearchtechnology GmbH | 2024-05-28 |
| Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K240629) | Xingyu Medical Tech Co., Ltd. | 2024-05-28 |
| Laser Speckle Imaging System (RFLSI CZW) (K233076) | Rwd Life Science Co., Ltd. | 2024-05-28 |
| Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) (K240874) | Theralaser Medtech (China) Co., Ltd. | 2024-05-28 |
| Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) (K240304) | Enpuno Biotechnology Co., Ltd. | 2024-05-28 |
| Regenalase Laser System (K233344) | Ipg Medical | 2024-05-28 |
| ANNE Limb (K240305) | Sibel Health, Inc. | 2024-05-28 |
| React 71 Catheter (K241177) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2024-05-28 |
| Wolff's Law Anterior Cervical Plate System (K240592) | Spinal Simplicity, LLC | 2024-05-24 |
| Anti Grinding Guard (K240810) | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 2024-05-24 |
| DEKA ACE Pump System (K241178) | Deka Research and Development | 2024-05-24 |
| SET-5002 (K240827) | Shimadzu Corporation Medical Systems Division | 2024-05-24 |
| ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC (K233111) | Foshan United Medical Technologies, Ltd. | 2024-05-24 |
| INSPIRA ART100 (K232788) | Inspira Technologies Oxy B.H.N. , Ltd. | 2024-05-24 |
| NeoSpan® Compression Implant System (K233089) | In2bones USA, LLC | 2024-05-24 |
| KATANA Zirconia ONE For IMPLANT (K233285) | Kuraray Noritake Dental, Inc. | 2024-05-24 |
| Monik™ - Disposable Endoscopic Trocar (K233386) | M/s. Meril Endo Surgery Private Limited. | 2024-05-24 |
| uPMR 790 (K234154) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| LVivo IQS (K240769) | Dia Imaging Analysis, Ltd. | 2024-05-24 |
| PacePro Wire (K240864) | Opsens, Inc. | 2024-05-24 |
| PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K233777) | Primed Medical Products, Inc. | 2024-05-24 |
| 8plant Implant System (K231426) | Hoowon Edi Co., Ltd. | 2024-05-24 |
| da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K240723) | Intuitive Surgical | 2024-05-24 |
| Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (K232646) | Cook Biotech Incorporated | 2024-05-24 |
| Renasys Edge (K231939) | Smith & Nephew Medical, Ltd. | 2024-05-24 |
| Apollo TMS Therapy System (K232639) | Mag & More GmbH | 2024-05-24 |
| Racz Neurostat RF Generator (K232632) | Epimed International | 2024-05-24 |
| CamAPS FX (K232603) | Camdiab , Ltd. | 2024-05-23 |
| 3DMatrix Surgical Mesh (K232602) | Printbio, Inc. | 2024-05-23 |
| Drill Guide; Drill Bit; Spine & Trauma Navigation (K240701) | Brainlab AG | 2024-05-23 |
| NOxBOXi Nitric Oxide Delivery System (K233251) | Linde Gas & Equipment, Inc. | 2024-05-23 |
| CWM-930S, FIXER DV9 (K233120) | Chungwoo Co., Ltd. | 2024-05-23 |
| 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) (K241134) | Kci USA, Inc. | 2024-05-23 |
| Syngo Carbon Enterprise Access (VA40A) (K240294) | Siemens Healthcare GmbH | 2024-05-23 |
| VinDr-Mammo (K233108) | Vinbigdata Joint Stock Company | 2024-05-23 |
| AirKEE T900 (K232642) | Healkee Medical Pte, Ltd. | 2024-05-23 |
| uCerv Flux™-C 3D Porous Titanium Cervical Interbody (K241396) | Ulrich Medical USA, Inc. | 2024-05-23 |
| dima Print Teeth & Temp (K233868) | Kulzer, LLC | 2024-05-23 |
| Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (K240097) | Ushare Medical, Inc. | 2024-05-22 |
| Biomet Kirschner Wires (K-Wires) (K241014) | Biomet, Inc. | 2024-05-22 |
| INUMI™ Flex Needle (K233884) | Galvanize Therapeutics, Inc. | 2024-05-22 |
| Zenition 90 (K240224) | Philips Medical Systems Nederlands B.V. | 2024-05-22 |
| Paltop Short Implants (K232740) | Paltop Advanced Dental Solutions, Ltd. | 2024-05-22 |
| Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap (K240456) | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2024-05-22 |
| Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) (K241106) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2024-05-22 |
| Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (K241100) | Co-Innovation Biotech Co., Ltd. | 2024-05-22 |
| Bonvadis® (K232655) | Stemcyte, Inc. | 2024-05-22 |
| Gladiator (K233099) | Rohrer Aesthetics, LLC | 2024-05-22 |
| Impress Angiographic Catheter (K233268) | Merit Medical Systems, Inc. | 2024-05-22 |
| Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820) | Edwards Lifesciences | 2024-05-22 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K241143) | Materialise NV | 2024-05-22 |
| Fogarty Venous Thrombectomy Catheters (K233819) | Edwards Lifesciences, LLC | 2024-05-22 |
| IntraOp Alignment System (K240199) | Alphatec Spine, Inc. | 2024-05-22 |
| OviTex PRS (K241126) | TELA Bio, Inc. | 2024-05-22 |
| 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 (DEN230068) | 3M Company | 2024-05-21 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K232759) | Brainlab AG | 2024-05-21 |
| 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (K233336) | Acula Technology Corp. | 2024-05-21 |
| Reia pessary (K232677) | Reia, LLC | 2024-05-21 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (K241110) | Centers for Disease Control and Prevention | 2024-05-21 |
| troCarWash™ System (K233442) | Biotex, Inc. | 2024-05-21 |
| Yumizen H2500 (K232946) | HORIBA ABX SAS | 2024-05-21 |
| ProSeal™ Injection Site Extended Male Luer Lock (422140) (K240433) | Epic Medical Pte. , Ltd. | 2024-05-21 |
| YSIO X.pree (K233543) | Siemens Medical Solutions | 2024-05-21 |