| VOLT™ Proximal Humerus 3.5 Plating System (K233994) | Synthes GmbH | 2024-07-26 |
| Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169) | Bausch and Lomb, Incorporated | 2024-07-26 |
| Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) (K241028) | Coloplast | 2024-07-26 |
| Symbia SPECT and SPECT/CT Systems (K241898) | Siemens Healthineers | 2024-07-26 |
| DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) (K241883) | Pro Med Instruments GmbH | 2024-07-26 |
| EasyStat 300 (K220328) | Medica Corporation | 2024-07-26 |
| Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246) | Synaptic Medical Corporation | 2024-07-26 |
| Alien Aligners (K241187) | Alien Milling Technologies | 2024-07-26 |
| Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (K241800) | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 |
| InnovaMatrix®FD (K241866) | Convatec Triad Life Sciences, LLC | 2024-07-26 |
| Cell-Free DNA BCT (K231776) | Streck, Inc. | 2024-07-26 |
| “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) (K233501) | Largan Medical Co., Ltd. | 2024-07-26 |
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| STAR Apollo™ Mapping System (K240509) | Rhythm AI, Ltd. | 2024-07-26 |
| Pantheon Pedicle Screw and Iliac Bolt Fixation System (K241494) | Pantheon Spinal | 2024-07-26 |
| NEXA™ NPWT System (K241515) | Nexa Medical Limited | 2024-07-26 |
| Arthrex Synergy Vision Endoscopic Imaging System (K241361) | Arthrex, Inc. | 2024-07-25 |
| Grappler Interference Screw System (K241864) | Paragon 28, Inc. | 2024-07-25 |
| KARL STORZ Fiber Telescopes for Urology (K233372) | Karl Storz SE & CO. KG | 2024-07-25 |
| PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) (K241203) | Dongguan Hunter Electronic Technology Co., Ltd. | 2024-07-25 |
| Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171) | Stryker Leibinger GmbH & Co KG | 2024-07-25 |
| s-Clean ScanHealing Abutment (K241063) | Dentis Co., Ltd. | 2024-07-25 |
| GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) (K241887) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 |
| Navident (K233563) | Claronav, Inc. | 2024-07-25 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |
| Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| Aptima HCV Quant Dx Assay (K233352) | Hologic, Inc. | 2024-07-24 |
| CADDIE (K240044) | Odin Medical Limited | 2024-07-24 |
| Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (K241243) | Centerline Biomedical, Inc. | 2024-07-24 |
| Insure® Universal; Insure® Universal Automix (K240714) | Cosmedent, Inc. | 2024-07-24 |
| ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (K240431) | Brainlab AG | 2024-07-24 |
| P-SCOPE (K241502) | Oui Medical, Inc. | 2024-07-24 |
| THE Graft Collagen (K230305) | Purgo Biologics, Inc. | 2024-07-24 |
| X-Smart Pro; X-Smart Pro+ (K233865) | Dentsply Sirona, Inc. | 2024-07-24 |
| MISTI Silicone Implant (K241150) | Keosan Trading Co. | 2024-07-24 |
| Erisma® Lp Spinal Fixation System; Erisma® LP MIS (K241863) | Clariance | 2024-07-24 |
| C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457) | Pentax of America, Inc. | 2024-07-24 |
| InMode RF System (K240780) | InMode , Ltd. | 2024-07-24 |
| FlexWing Anterior Cervical Plate System (K231251) | Jeil Medical Corporation | 2024-07-24 |
| Non-Sterile Ultrasound Transmission Gels (K241789) | Hony Medical Co., Ltd. | 2024-07-24 |
| “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130) | Point Robotics MedTech, Inc. | 2024-07-24 |
| Gaudi Proximal Humerus Plate (K241296) | Netbiologics, LLC | 2024-07-23 |
| EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (K241114) | Ewoosoft Co., Ltd. | 2024-07-23 |
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
| TE Air Diagnostic Ultrasound System (K240906) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-07-23 |
| Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) (K240339) | Shanghai Bangbang Robotics Co., Ltd. | 2024-07-22 |
| Kinos Total Ankle System (K241482) | Restor3D | 2024-07-22 |
| Transcutaneous Electrical Nerve Stimulator (K6106) (K241119) | Shenzhen Yicai Health Technology Co., Ltd. | 2024-07-22 |
| Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (K234091) | Genalyte, Inc. | 2024-07-22 |
| neo315 (K231133) | Neoscan Solution GmbH | 2024-07-22 |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704) | Siemens Medical Solutions USA, Inc. | 2024-07-22 |
| K-Bond Universal (K241445) | Spident Co., Ltd. | 2024-07-22 |
| Onycho Laser V (K241116) | Terasysd&C, Inc. | 2024-07-22 |
| NAVOYCDS (K240558) | Algodx AB | 2024-07-22 |
| PTG-05 (K240347) | Zimmer Medizinsysteme GmbH | 2024-07-21 |
| VasoGuard (V10, V8, V6, V4, V2) (K233976) | Corvascular Diagnostics, LLC | 2024-07-19 |
| Senhance Surgical System (K233866) | Asensus Surgical, Inc. | 2024-07-19 |
| IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (K240480) | Varian Medical Systems, Inc. | 2024-07-19 |
| coactiv+™ Antimicrobial Wound Gel (K241809) | Kane Biotech, Inc. | 2024-07-19 |
| Suture Button Repair System (K240835) | Skeletal Dynamics, Inc. | 2024-07-19 |
| Premium Teeth Resin (K240538) | Formlabs Ohio, Inc. | 2024-07-19 |
| VACUETTE® QUICKSHIELD Complete (Plus) (K233979) | Greiner Bio-One North America, Inc. | 2024-07-19 |
| Wireless TENS & EMS (Model SM9110,SM9113,SM9116) (K233067) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-07-19 |
| HardyDisk AST Cefiderocol 30µg (FDC30) (K241060) | Hardy Diagnostics | 2024-07-18 |
| Papacarie Duo (K233768) | Elevate Oral Care | 2024-07-18 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K241240) | Hologic, Inc. | 2024-07-18 |
| SOLID CLIP™ Single Use Clip Applier (K221495) | Medscope Biotech Co., Ltd. | 2024-07-18 |
| Field Shield Wound Dressing (K212521) | Kericure, Inc. | 2024-07-18 |
| Quantum Perfusion Hybrid System (K241206) | Spectrum Medical S.R.L. | 2024-07-18 |
| ICHOR 7F Embolectomy System (ICH-7F) (K233917) | Ichor | 2024-07-18 |
| B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 |
| Juliet® Ti LL Lumbar Interbody Device (K241321) | Spineart SA | 2024-07-18 |
| Surgical Drive System (Model: ES70, ES90, E8) (K240340) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-07-18 |
| Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) (K241463) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2024-07-18 |
| vRad Viewer (K241879) | Virtual Radiologic Corporation | 2024-07-18 |
| Equinoxe® Central Screw Baseplate System (K233482) | Exactech, Inc. | 2024-07-18 |
| CEFALY Connected - OTC, CEFALY Connected - Rx (K234029) | Cefaly Technology | 2024-07-18 |
| S.I.N. Dental Implant System (K240609) | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-17 |
| Rayvolve (K240845) | Azmed Sas | 2024-07-17 |
| Stable-C Interbody System (K241467) | Nexus Spine, LLC | 2024-07-17 |
| Vitrea Software Package, VSTP-002A V2.0 (K240705) | Canon Medical Systems Corporation | 2024-07-17 |
| MICSI-RMT (K241121) | Microstructure Imaging, Inc. | 2024-07-17 |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) | Acist Medical Systems, Inc. | 2024-07-17 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (K241081) | Topcon Corporation | 2024-07-17 |
| sagAlign Lumbar Cage System (Various PNs) (K241413) | Acuity Surgical Devices, LLC | 2024-07-17 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K240503) | Gynesonics, Inc. | 2024-07-17 |
| RadiForce RX670; RadiForce RX670-AR (K241441) | Eizo Corporation | 2024-07-16 |
| Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (K233778) | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 |
| SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel (K241741) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 |
| Light Cure Adhesive (K241056) | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 |
| allay Nerve Cap (DEN230061) | Tulavi Therapeutics | 2024-07-16 |
| Swoop® Portable MR Imaging® System (K240944) | Hyperfine, Inc. | 2024-07-16 |
| Electric Scooter (M2085, S2091) (K240272) | Guangdong Prestige Technology Co., Ltd. | 2024-07-16 |
| Finesse Injectable™ PTA Balloon Dilatation Catheter (K241740) | Summa Therapeutics | 2024-07-16 |
| CrossRoads Modular Tray System (K241050) | Crossroads Extremity Systems | 2024-07-16 |
| FAQ™ (102) (K240616) | Foreo, Inc. | 2024-07-15 |
| BellaTek Bars (K241032) | Biomet 3i, LLC | 2024-07-15 |
| Endoscopic Applicator, 41 cm (K241739) | Micromedics, Inc. | 2024-07-15 |
| RFG-01 (K240178) | Zimmer Medizinsysteme GmbH | 2024-07-15 |
| Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (DEN230092) | Diasorin Molecular, LLC | 2024-07-15 |