| TriMed Ankle Fixation System (K243999) | TriMed, Inc. | 2025-03-19 |
| SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (K250502) | Safesource Direct, LLC | 2025-03-19 |
| Sunny (K242241) | ShenB Co., Ltd. | 2025-03-19 |
| Tyber Medical Anatomical Plating System (K242486) | Tyber Medical, LLC | 2025-03-19 |
| TriMed Elbow and Forearm System (K243987) | TriMed, Inc. | 2025-03-19 |
| EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (K243443) | DRTECH Corporation | 2025-03-19 |
| LYHER® Oral fluid Multi-Drug Test Kit (Cube) (K240287) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 |
| Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242533) | Better Care Plastic Technology Co., Ltd. | 2025-03-18 |
| Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (K243807) | Olympus Medical Systems Corp. | 2025-03-18 |
| FortiVy™ OsteoVy™ Lumbar IBF (K241783) | Vy Spine, LLC | 2025-03-18 |
| Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (K243556) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| Aglaia LED Beauty Device (BP-D2309) (K250413) | Shenzhen Perfect Idea Technology Limited | 2025-03-18 |
| Radlink GPS Pro Imaging (K242161) | Radlink, Inc. | 2025-03-18 |
| QP-Prostate® CAD (K242683) | Quibim S.L. | 2025-03-18 |
| CarbonCool® System (K240933) | Global Healthcare SG Sdn. Bhd | 2025-03-18 |
| QuikClot Control+ Hemostatic Device (K243553) | Teleflex Medical | 2025-03-18 |
| The OsteoCentric Bone Plate and Screw System (K250494) | OsteoCentric Technologies | 2025-03-18 |
| Klarity SGRT System (ARSG-E1A, ARSG-E3A) (K241937) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 |
| Hard Splint & Thermo-Adaptive Splint (K241729) | Whip Mix Corporation | 2025-03-18 |
| SERV MEDICAL CDSS (K241975) | Serv Medical Pte., Ltd. | 2025-03-17 |
| UPT Series Medical RO Water Treatment System (K250514) | Specialty Water Technologies, Inc. | 2025-03-17 |
| Air Compression Leg Massager (K-705) (K242140) | Jiale Health Technology Shenzhen Co., Ltd. | 2025-03-17 |
| LAGIS Suction Irrigation System (K243867) | Lagis Enterprise Co., Ltd. | 2025-03-17 |
| MAIA (AHMACME001) (K243504) | Centervue S.P.A. | 2025-03-17 |
| DOC Band 3D (K244056) | Cranial Technologies, Inc. | 2025-03-17 |
| LVivo Software Application (K243862) | Dia Imaging Analysis, Ltd. | 2025-03-17 |
| Ziehm Solo FD (K243646) | Ziehm Imaging GmbH | 2025-03-17 |
| BPS Wrist Fracture System (K250498) | Orthonovis, Inc. | 2025-03-17 |
| aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (K243802) | Carlsmed, Inc. | 2025-03-17 |
| 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) (K243869) | The Magstim Company Limited | 2025-03-17 |
| SIGNA Prime Elite (K250379) | Ge Medical Systems, LLC | 2025-03-17 |
| Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca (K250439) | Contract Medical International, GmbH | 2025-03-16 |
| Maestro System (REF100) (K242323) | Moon Surgical | 2025-03-14 |
| Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (K250267) | Kettenbach GmbH & Co. KG | 2025-03-14 |
| Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (K250526) | Arthrex, Inc. | 2025-03-14 |
| Promisemed Safety Huber Needles (K243332) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 |
| VITEK COMPACT PRO (K234012) | bioMerieux, Inc. | 2025-03-14 |
| One-Fil Putty (K243353) | Mediclus Co., Ltd. | 2025-03-14 |
| Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (K242010) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-03-14 |
| BodyTom 64 (K242811) | Neurologica Corporation, A Subsidiary of Samsung | 2025-03-14 |
| KOROT Blood Pressure Monitor (KOROT P3 Accurate) (K250091) | Korot Co., Ltd. | 2025-03-14 |
| VerteGlide Spinal Growth Guidance System (K241816) | OrthoPediatrics Corp. | 2025-03-14 |
| Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (K243599) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 |
| PLANET Onco Dose (3.2) (K241765) | Dosisoft SA | 2025-03-14 |
| Viewer+ (K242244) | Lumea, Inc. | 2025-03-14 |
| NEXXT MATRIXX® SI System (K243838) | Nexxt Spine | 2025-03-14 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243931) | Centers for Disease Control and Prevention | 2025-03-14 |
| Ruby XL System (K250079) | Penumbra, Inc. | 2025-03-14 |
| mBôs (Monogram mBôs TKA System) (K242121) | Monogram Orthopaedics, Inc. | 2025-03-14 |
| Solution Administration Sets (K243529) | Baxter Healthcare Corporation | 2025-03-14 |
| AION TempShield™ (K250401) | Aion Biosystems, Inc. | 2025-03-14 |
| DeepRESP (K241960) | Nox Medical Ehf | 2025-03-14 |
| Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (K250025) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-03-14 |
| neoLaser Laser Surgery Fibers (K250113) | G.N.S Neolaser , Ltd. | 2025-03-13 |
| MedCAD® AccuStride™ System (K241811) | Medcad | 2025-03-13 |
| Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (K250380) | Surgify Medical OY | 2025-03-13 |
| xvision Spine system (K250255) | Augmedics, Ltd. | 2025-03-13 |
| SiOxC Cream (K242406) | Sioxmed, LLC | 2025-03-13 |
| 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (K244022) | Boston Aesthetics, Inc. | 2025-03-13 |
| Ziehm Vision FD (K243735) | Ziehm Imaging GmbH | 2025-03-13 |
| Turbo-Elite Laser Atherectomy Catheter (K250385) | Spectranetics | 2025-03-13 |
| Freedom Total Knee System (All-poly Tibial Plate) (K250382) | Maxx Orthopedics, Inc. | 2025-03-13 |
| CryoFreeze Wart and Skin Tag Remover (K243487) | Cryosurgery, Inc. | 2025-03-13 |
| FlowTriever2 Catheter (K250088) | Inari Medical, Inc. | 2025-03-13 |
| MY01 Continuous Compartmental Pressure Monitor (K242997) | MY01, Inc. | 2025-03-13 |
| IceCap product line (K243788) | Bioserenity Medical Devices Group | 2025-03-13 |
| Photon Therapy Apparatus (BL-10) (K243993) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-03-13 |
| ReWalk® 7 Personal Exoskeleton (50-20-0005) (K241822) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 |
| BioFire Warrior Panel; BioFire Warrior Panel Control Kit (K243822) | Biofire Defense, LLC | 2025-03-12 |
| 2430TCA with Xmaru W (K243849) | Rayence Co., Ltd. | 2025-03-12 |
| EVOL® ha – Hyper C Cervical Interbody Fusion System (K250605) | Cutting Edge Spine, LLC | 2025-03-12 |
| Wireless TENS & EMS Unit (K243763) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 |
| Delphi Amplifier (K243746) | Quantalx Neroscience | 2025-03-12 |
| DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) | Dannik, LLC | 2025-03-12 |
| RCT600 (K243903) | Ray Co., Ltd. | 2025-03-12 |
| Walking rehabilitation training electric wheelchair (ZW518) (K243783) | Shenzhen Zuowei Technology Co., Ltd. | 2025-03-12 |
| PICOALEX (K243957) | Wontech Co., Ltd. | 2025-03-12 |
| RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357) | Deka Research & Development Corp. | 2025-03-11 |
| 8mm Monopolar Curved Scissors (470179) (K242610) | Iconocare Health | 2025-03-11 |
| Arthrex TightRope Soft Button, RT (K250424) | Arthrex, Inc. | 2025-03-11 |
| OutFlo Aortic Valve Dilatation Balloon Catheter (K241562) | Disa Medinotec | 2025-03-11 |
| Origin™ TT Stem (K243029) | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |
| Better Diagnostics Caries Assist (BDCA) Version 1.0 (K241725) | Better Diagnostics AI Corp. | 2025-03-11 |
| iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (K250374) | Stryker Instruments | 2025-03-11 |
| AGILON® XO Shoulder Replacement System (K241944) | Implantcast GmbH | 2025-03-10 |
| Alteon® HA Femoral Stems (K243839) | Exactech, Inc. | 2025-03-10 |
| da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596) | Intuitive Surgical, Inc. | 2025-03-10 |
| Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (K243101) | Surgical Instrument Service and Savings, Inc. | 2025-03-10 |
| Wound Treatment System (VHT-200) (K250188) | Vaporox, Inc. | 2025-03-10 |
| Duet External Drainage and Monitoring System (EDMS) (K243676) | Medtronic Neurosurgery | 2025-03-10 |
| Op.n(TM) Navigation (K242914) | Ecential Robotics | 2025-03-07 |
| NOABLE LASER (K242207) | Daeju Meditech Engineering Co., Ltd. | 2025-03-07 |
| Portable Wheelchair (K243970) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-03-07 |
| Apex Locator (K242383) | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 |
| Orthex External Fixation System (K243798) | OrthoPediatrics Corp. | 2025-03-07 |
| Cleerly LABS (v2.0) (K242338) | Cleerly, Inc. | 2025-03-07 |
| Geistlich Bio-Flow® (K242510) | Geistlich Pharma AG | 2025-03-07 |
| ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (K241799) | Atmos Medizintechnik GmbH & Co. KG | 2025-03-07 |
| EpiWatch Monitoring System (K243515) | Epiwatch, Inc. | 2025-03-07 |
| Handbike Batec Electric (K241159) | Batec Mobility, S.L. | 2025-03-07 |