| Imbio PHA (4.0.0) (K241847) | Imbio, Inc. | 2024-08-30 |
| Salto Talaris Ankle PSI System (K241148) | 3D Systems, Inc. | 2024-08-30 |
| Cadence Ankle PSI System (K241326) | 3D Systems, Inc. | 2024-08-30 |
| uMI Panorama (K241585) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 |
| Daylight (K233872) | Big Health, Inc. | 2024-08-30 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) (K241583) | Remington Medical, Inc. | 2024-08-30 |
| MI View&GO (K242300) | Siemens Medical Solutions USA, Inc. | 2024-08-30 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (K233107) | Canon Medical Systems Corporation | 2024-08-30 |
| ToxiSeal™ Vial Adaptor (K241823) | Epic Medical Pte. , Ltd. | 2024-08-30 |
| Heyman Packing Applicator Set (GM11004580) (K241386) | Varian Medical Systems, Inc. | 2024-08-30 |
| Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (K241518) | The Magstim Company Limited | 2024-08-30 |
| Unipro (K-UNIPRO-US) (K232441) | Tenscare, Ltd. | 2024-08-30 |
| Orthopeasia Spinal Fixation System (K240180) | Orthopeasia Co., Ltd. | 2024-08-30 |
| WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV (K240464) | Boston Scientific | 2024-08-30 |
| IPL Hair Removal Device (JM-843, JM-865, JM-638) (K241881) | Shenzhen Junmei Technology Co., Ltd. | 2024-08-29 |
| SkinPen Precision Elite System (K241400) | Crown Aesthetics | 2024-08-29 |
| RHYTHMIA HDx™ Mapping System (K241227) | Boston Scientific Corporation | 2024-08-29 |
| 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 Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips (K242280) | Stryker Spine | 2024-08-29 |
| Target Detachable Coils (K242243) | Stryker Neurovscular | 2024-08-29 |
| VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (K242296) | Ortho-Design (Pty), Ltd. | 2024-08-29 |
| Ensol EnTM Specimen Collection and Transport System (K220908) | Ensol Biosciences, Inc. | 2024-08-29 |
| Navigator (FMNVG15); Navigator XL (FMNVX06) (K240105) | Forcemech International, LLC | 2024-08-29 |
| Grass® MR Conditional/CT Cup Electrodes (K242346) | Natus Manufacturing Limited | 2024-08-29 |
| Kosmos (K233826) | EchoNous, Inc. | 2024-08-29 |
| Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask (K241943) | Sleepnet Corporation | 2024-08-28 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| BT-1000 (K232991) | Bistos Co., Ltd. | 2024-08-28 |
| VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
| Cercon® yo ML (K241557) | Dentsply Sirona | 2024-08-28 |
| OxiWear (K233827) | Oxiwear, Inc. | 2024-08-28 |
| REDEMPTION Charcot Plating System (K233816) | Vilex, LLC | 2024-08-28 |
| GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (K240545) | Genabio Diagnostics, Inc. | 2024-08-28 |
| Chronos® (DEN230067) | Germitec | 2024-08-28 |
| Safety Lancet (K242316) | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| Vista BC Putty (K241457) | Inter-Med, Inc. | 2024-08-28 |
| OSSIOfiber® Compression Staple (K241932) | OSSIO , Ltd. | 2024-08-28 |
| da Vinci Handheld Camera (K241913) | Intuitive Surgical Operations, Inc. | 2024-08-28 |
| Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 |
| TENSWave (K241228) | Zynex Medical Officer | 2024-08-27 |
| Sealer Solvent (K241354) | Inter-Med, Inc. | 2024-08-27 |
| Electric wheelchair (S7018) (K240270) | Guangdong Prestige Technology Company Limited | 2024-08-27 |
| Vitrification Solution Set and Warming Solution Set (K233846) | Ecmpc, LLC | 2024-08-27 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (K241787) | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 |
| Overjet Charting Assist (K241684) | Overjet, Inc. | 2024-08-27 |
| injeTAK Adjustable Tip Needle (DIS199; DIS201) (K241523) | Laborie Medical Technologies, Corp. | 2024-08-27 |
| Isolator Synergy EnCapture Ablation System (EMH) (K234151) | AtriCure, Inc. | 2024-08-27 |
| BracePaste Fluoride Sealant (K242537) | American Orthodontics Corp. | 2024-08-27 |
| Q Guidance System; Mako Spine System; (K241517) | Stryker Leibinger GmbH & Co KG | 2024-08-27 |
| Z1 Cemented Hip System (K241241) | Orchard Medical Development, LLC | 2024-08-27 |
| MyoStrain (6.0) (K241607) | Myocardial Solutions, Inc. | 2024-08-26 |
| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K241850) | Ulrich GmbH & Co. KG | 2024-08-26 |
| FiAPC plus probes (K242044) | Erbe Elektromedizin GmbH | 2024-08-26 |
| SmartAdjust™ Technology (K241777) | Insulet Corporation | 2024-08-26 |
| BARS Set (100.60) (K241858) | Ovesco Endoscopy AG | 2024-08-26 |
| TriClip Steerable Guide Catheter (K241538) | ABBOTT MEDICAL | 2024-08-26 |
| PRIMED Surgical Masks and PRIMED Procedure Masks (K240286) | Primed Medical Products, Inc. | 2024-08-26 |
| DESS Dental Smart Solutions (K240982) | Terrats Medical SL | 2024-08-26 |
| ONE Nitrile Condom (K240896) | Global Protection Corp. | 2024-08-23 |
| Morph DNA Steerable Introducer Sheath (K242169) | Biocardia | 2024-08-23 |
| SCoV-2 Ag Detect Rapid Test (K233358) | InBios International, Inc. | 2024-08-23 |
| SonoSync (K241302) | Samsung Medison Co., Ltd. | 2024-08-23 |
| TMINI Miniature Robotic System (K242264) | THINK Surgical, Inc. | 2024-08-23 |
| Guided Surgery Kit Cases (K241492) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 |
| Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) (K233829) | Fisher and Paykel Healthcare Limited | 2024-08-23 |
| Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw (K231100) | Proimtech Saglik Urunleri Anonim Sirketi | 2024-08-23 |
| SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K242191) | Olympus Surgical Technologies America | 2024-08-23 |
| Cardinal Health Nitrile Exam Gloves (K241780) | Cardinal Health200, LLC | 2024-08-23 |
| SITTER 3.5mm Versatile System (K240318) | Bonebridge AG | 2024-08-23 |
| Polyisoprene Surgical gloves (K240790) | Suzhou Colour-Way New Material Co., Ltd. | 2024-08-23 |
| LightWalker Laser System Family (K242202) | Fotona D.O.O. | 2024-08-23 |
| VEEGix EEG System (K240593) | NeuroServo, Inc. | 2024-08-23 |
| Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801) | Boston Scientific Neuromodulation | 2024-08-23 |
| INSULCLOCK® v2.0 PRO (K241803) | Insulcloud S.L. | 2024-08-22 |
| LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) (K240227) | Lina Medical Aps | 2024-08-22 |
| NeuroQuant (K241098) | Cortechs Labs, Inc. | 2024-08-22 |
| Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) (K241979) | Beijing Konted Medical Technology Co.,Ltd | 2024-08-22 |
| Phantom Fibula Nail System (K234128) | Paragon 28, Inc. | 2024-08-22 |
| Introducer Sheath Kits (K242248) | Beijing Demax Medical Technology Co.,Ltd | 2024-08-22 |
| I.V. Administration Set (K242126) | Bq Plus Medical Co., Ltd. | 2024-08-22 |
| Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System (K230071) | Tdm Co., Ltd. | 2024-08-22 |
| LIJIA Night Guard (K241369) | Lijia, LLC | 2024-08-22 |
| iCare ALTIUS CW (K234076) | Centervue S.P.A. | 2024-08-22 |
| Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109) | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 |
| TRIGEN INTERTAN 10S Nail System (K241804) | Smith & Nephew, Inc. | 2024-08-22 |
| iSage Rx (K242066) | Amalgam Rx, Inc. | 2024-08-21 |
| Glidewire GT-R (K240859) | Terumo Corporation | 2024-08-21 |
| Kerecis Parvus (50207) (K241080) | Kerecis Limited | 2024-08-21 |
| VERSA Negative Pressure Wound Therapy System (VCMPP-100) (K241061) | Cork Medical | 2024-08-21 |
| Fraxel® FTX Laser System (K242142) | Solta Medical | 2024-08-21 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (K240298) | Bionova Medical, Inc. | 2024-08-21 |
| Blood Pressure Monitor (TMB-2092-G) (K241351) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-08-21 |
| AiMIFY (1.x) (K240290) | Subtle Medical, Inc. | 2024-08-21 |
| cCeLL - In vivo (K233391) | VPIX Medical, Inc. | 2024-08-21 |
| TiLink-P SI Joint Fusion System (K242141) | SurGenTec, LLC | 2024-08-21 |
| Nalu Neurostimulation System for Peripheral Nerve Stimulation (K232415) | Boston Scientific Neuromodulation | 2024-08-21 |
| MULA (K2-A1) (K240314) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 |
| Montage-XT Settable, Resorbable Bone Putty (K233566) | Orthocon, Inc. | 2024-08-21 |
| PYXIS 3D Titanium Cervical Cage system (K241738) | GS Medical Co., Ltd. | 2024-08-20 |
| ClearCap Distal Attachment (K242134) | Finemedix Co., Ltd. | 2024-08-20 |