| Cove Putty, OsteoCove Putty (K242273) | SeaSpine Orthopedics Corporation | 2024-09-25 |
| Vybe RF II (K241535) | ShenB Co., Ltd. | 2024-09-25 |
| NovaBone Putty - Synthetic Bioactive Bone Graft (K242299) | Novabone Products, LLC | 2024-09-25 |
| Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K242075) | Penumbra, Inc. | 2024-09-25 |
| Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) (K242204) | Dongguan Quanding Medical Supplies Co., Ltd. | 2024-09-25 |
| Diode Laser Hair Removal System (K241860) | Beijing Winkonlaser Technology Limited | 2024-09-25 |
| IVD CAPSULE PSP; abioSCOPE (K240041) | Abionic SA | 2024-09-25 |
| RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (K240434) | Li Medical Corporation , Ltd. | 2024-09-25 |
| MOLLI 2 System (K240042) | Molli Surgical, Inc. | 2024-09-25 |
| Celsio Flexible Cryocatheter System (K240776) | Endocision Technologies, Inc. | 2024-09-24 |
| AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System (K234134) | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 |
| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| LumiVy™ Lumbar IBF System (K233807) | Vy Spine, LLC | 2024-09-24 |
| Ion Endoluminal System (IF 1000) (K242070) | Intuitive Surgical, Inc. | 2024-09-24 |
| uAI Easy Triage ICH (K242292) | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 |
| Aspiration Catheter (2189) (K241874) | Hobbs Medical, Inc. | 2024-09-24 |
| EConsole2 (K240243) | DRTECH Corporation | 2024-09-23 |
| Unity Total Knee System (K241570) | Corin U.S.A. Limited | 2024-09-23 |
| EchoGo Heart Failure (2.0) (K240013) | Ultromics Limited | 2024-09-23 |
| IPL Hair Removal Device (BE932C, BE932D, BE932E) (K241834) | Shenzhen Yang WO Electronic Co., Ltd. | 2024-09-23 |
| Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880) | Nakanishi, Inc. | 2024-09-20 |
| MTONE EVO (MTONE EVO) (K240604) | M&T S.R.L. | 2024-09-20 |
| Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K242504) | Perfuze, Ltd. | 2024-09-20 |
| Ecomed Disposable Administration Sets (K234129) | Ecomed Solutions, LLC | 2024-09-20 |
| SuperSonic HepaVu (K242223) | Supersonic Imagine | 2024-09-20 |
| aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (K241332) | Carlsmed, Inc. | 2024-09-20 |
| Traus SSG10 Surgical System (K233153) | Saeshin Precision Co., Ltd. | 2024-09-20 |
| Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821) | Sol-Millennium Medical, Inc. | 2024-09-20 |
| NeuroField Analysis Suite (K240420) | Neurofield, Inc. | 2024-09-20 |
| zLOCK Lumbar Facet Fixation System (K242650) | Zygofix , Ltd. | 2024-09-20 |
| HiCardi+ H100 (K232670) | MEZOO Co., Ltd. | 2024-09-20 |
| Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (K242147) | Alphatec Spine, Inc. | 2024-09-20 |
| Microwave Ablation Antennas (K241825) | Canyon Medical, Inc. | 2024-09-20 |
| ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) (K234108) | Energy Resources International Co., Ltd. | 2024-09-20 |
| TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061) | Smith & Nephew, Inc. | 2024-09-20 |
| Derma-R Cream (Derma-R Cream) (K240722) | Raya Pharmaceuticals, LLC | 2024-09-20 |
| PIUR tUS Infinity (K240036) | Piur Imaging GmbH | 2024-09-20 |
| Pectus Blu Support Bar System (K241709) | Biomet Microfixation | 2024-09-19 |
| MonoStereo (K234096) | Medicaltek Co., Ltd. | 2024-09-19 |
| Midas Flowmeter; eAVS (K241465) | Parker Hannifin Corporation | 2024-09-19 |
| Sterile and Non-Sterile Ultrasonic Coupling Agent (K242167) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-09-19 |
| Star E900 Handpiece Series (K240183) | Dentalez, Inc., Stardental Division | 2024-09-19 |
| Coconut Hybrid (K242162) | Good Clean Love, Inc. | 2024-09-19 |
| Stethophone (K240901) | Sparrow Acoustics, Inc. | 2024-09-19 |
| HAnano InterFuse(R) Modular Interbody (K242509) | Next Orthosurgical | 2024-09-19 |
| GF85 (models GF85-3P, GF85-SP) (K242478) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| InnoCare Specialty Foley Catheter (K241424) | Innocare Urologics, LLC | 2024-09-18 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) | Xelite Biomed , Ltd. | 2024-09-18 |
| Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K231383) | Terragene S.A. | 2024-09-18 |
| LOWTEM Crystal 120 (K231893) | Lowtem Co., Ltd. | 2024-09-18 |
| Response Ortho Metaphyseal Hinge Fixator System (K241769) | Response Ortho Solutions, LLC | 2024-09-18 |
| Copra Supreme (K233064) | Whitepeaks Dental Solutions GmbH | 2024-09-18 |
| TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142) | Megagen Implant Co., Ltd. | 2024-09-18 |
| Perpak™ Sterilization Tyvek Pouch (K241123) | Km Corp. | 2024-09-18 |
| Arrow® Nitinol Wire (K241784) | Teleflex Medical | 2024-09-18 |
| EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) (K234153) | Edgelife Technologies, LLC | 2024-09-18 |
| 3D Printed PEEK Interbody System (K240250) | Nvision Biomedical Technologies, Inc. | 2024-09-17 |
| Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (K240660) | Kulzer, LLC | 2024-09-17 |
| Medline Reusable Sterilization Wrappers (K234132) | Medline Industries, LP | 2024-09-17 |
| KLS Martin Drill-Free MMF Screw (K233721) | KLS-Martin L.P. | 2024-09-17 |
| Neo Sculptor (OF-NEO001) (K242186) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | 2024-09-17 |
| PADLOCK CLIP EFTR Kit (00713229) (K240274) | STERIS Corporation | 2024-09-17 |
| STS (K240293) | Techbopulm, Ltd. | 2024-09-17 |
| TriMed Bridge Plates (K241942) | TriMed, Inc. | 2024-09-17 |
| Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 (K241230) | Togo Medikit Co., Ltd. | 2024-09-17 |
| Robin's Egg (K240689) | Telebrands Corporation | 2024-09-17 |
| Air compression Leg Massager (MM0520, MM0521, MM0522) (K240373) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2024-09-17 |
| Eversense 365 Continuous Glucose Monitoring (CGM) System (K241335) | Senseonics, Incorporated | 2024-09-16 |
| Liftendo; Liftendo 2.0 (K241771) | Medical San Indústria DE Equipamentos Médicos Ltda. | 2024-09-16 |
| HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050) | O&M Halyard, Inc. | 2024-09-16 |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System (K241201) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-16 |
| CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (K241893) | Medos International SARL | 2024-09-16 |
| Traus SSG30 Surgical System (K232938) | Saeshin Precision Co., Ltd. | 2024-09-16 |
| OneMark (K241762) | View Point Medical | 2024-09-16 |
| Power Wheelchair (YH-E7007) (K240638) | Ningbo Youhuan Automation Technology Co., Ltd. | 2024-09-16 |
| Powered Wheelchair (NXN20-205, NXN20-205M) (K241379) | Zhejiang Nysin Medical Co., Ltd. | 2024-09-16 |
| DNA Appliance (K234089) | Vivos Therapeutics | 2024-09-16 |
| Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 (K241156) | Surgical Instrument Service and Savings, Inc. | 2024-09-14 |
| DenQ Sub SLA Implant System (K240977) | Denq | 2024-09-13 |
| Epitomee (K240544) | Epitomee Medical , Ltd. | 2024-09-13 |
| Revian Lyte (10011) (K242441) | Revian, Inc. | 2024-09-13 |
| RT Carbon ECG Leads (K240087) | Ivy Biomedical Systems, Inc. | 2024-09-13 |
| TheRay Collared and Collarless Femoral Stem (K241875) | Nextstep Arthropedix | 2024-09-13 |
| Vitruvian Liposaber (K240188) | Black & Black Surgical, Inc. | 2024-09-13 |
| T2Candida 1.1 Panel (K234063) | T2biosystems, Inc. | 2024-09-13 |
| Microdacyn Wound Care Solution (K233399) | Sonoma Pharmaceuticals, Inc. | 2024-09-13 |
| V-VITFREEZE and V-VITWARM (K240176) | Vitromed GmbH | 2024-09-13 |
| EK D3.3 and Ultra Wide Implants (K240232) | Hiossen, Inc. | 2024-09-13 |
| Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (K241722) | Elos Medtech Pinol A/S | 2024-09-13 |
| Sleep Apnea Notification Feature (SANF) (K240929) | Apple, Inc. | 2024-09-13 |
| Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (K241249) | Palodex Group OY | 2024-09-12 |
| MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K241432) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-12 |
| Constellation (CON-001) (K241280) | Q Bio, Inc. | 2024-09-12 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) (K241582) | Canon Medical Systems Corporation | 2024-09-12 |
| Surgikor Fixation One, Abutment Blanks and Abutments (K240803) | Surgikor, LLC | 2024-09-12 |
| N7-S (K240168) | Nuga Medical Co., Ltd. | 2024-09-12 |
| CoolSculpting Elite System (K233732) | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024-09-12 |
| EXULT Knee Replacement System (K242401) | Corentec Co., Ltd. | 2024-09-12 |
| Hipro Glycosylated Hemoglobin (HbA1c) Test System (K220999) | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K241710) | 3M Company | 2024-09-12 |