| ProLift Expandable Spacer System (K250373) | Life Spine, Inc. | 2025-04-09 |
| CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (K242429) | Becton Dickinson Inc. (Bd) | 2025-04-09 |
| Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) (DEN240021) | Active Protective Technologies, Inc. | 2025-04-09 |
| AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (K250752) | Integra LifeSciences Corporation | 2025-04-09 |
| Luminopia (K243819) | Luminopia, Inc. | 2025-04-09 |
| Dexcom G7 15 Day Continuous Glucose Monitoring System (K243214) | Dexcom, Inc. | 2025-04-09 |
| Ceribell Seizure Detection Software (K241589) | Ceribell, Inc. | 2025-04-09 |
| Patch-TEA (Model TRI-21) (K243613) | Transtimulation Research, Inc. | 2025-04-09 |
| Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (K242151) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-04-08 |
| Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) (K243722) | Selio Medical Limited | 2025-04-08 |
| Jmoon Conductive Gel (K243749) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-04-08 |
| TriMed Fusion Cup System (K250948) | TriMed, Inc. | 2025-04-08 |
| Globalcare Blood Pressure Monitor (GUS610) (K250136) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 |
| Horos Mobile (K242552) | Icat Solutions, Ltd. | 2025-04-08 |
| BunkerHill BMD (K242295) | BunkerHill Health | 2025-04-08 |
| Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (K243027) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| ONE Nitrile Condom (K243967) | Global Protection Corp. | 2025-04-08 |
| Electric Wheelchair (LW01301A07) (K250366) | Anhui Longway Medical Technology Co., Ltd. | 2025-04-08 |
| NPseal (K250708) | Guard Medical, Inc. | 2025-04-08 |
| LuxCreo Clear Aligner System (K250343) | LuxCreo, Inc. | 2025-04-08 |
| Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) (K250033) | Guangzhou Pinzhi Medical Technology Co., Ltd. | 2025-04-07 |
| E-PEN (E-PEN) (K243143) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| Tyto Insights for Rhonchi Detection (K243567) | Tyto Care , Ltd. | 2025-04-07 |
| BioBrace ® RC Delivery System (K250395) | Conmed Corporation | 2025-04-07 |
| NanoBone® SBX Putty ; NanoBone® QD (K250521) | Biocomposites, Ltd. | 2025-04-07 |
| LED Therapy Mask (MN1, M226) (K242385) | Shenzhen Borria Technology Co., Ltd. | 2025-04-07 |
| Ultraviolet Phototherapy Device (K250425) | APK Technology Co., Ltd. | 2025-04-07 |
| Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (K250011) | Turbett Surgical | 2025-04-04 |
| TRIOS Ready Tip (K242103) | 3Shape TRIOS A/S | 2025-04-04 |
| LiquID .051 LP Guide Catheter Extension (K243691) | Seigla Medical, Inc. | 2025-04-04 |
| AllTest Viral Transport Medium (K242576) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (K250656) | Wuhan Pioon Technology Co., Ltd. | 2025-04-04 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |
| K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (K243581) | Terumo Europe N.V. | 2025-04-04 |
| LED Light Therapy Mask (RT01) (K242068) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 2025-04-04 |
| QFR (3.0) (K243769) | Qfr Solutions BV | 2025-04-04 |
| Spectrum Spine Lumbar Cage System (K243074) | Spectrum Spine, Inc. | 2025-04-04 |
| JETi Hydrodynamic Thrombectomy System (K243549) | ABBOTT MEDICAL | 2025-04-04 |
| Prapela SVS hospital bassinet pad (model P01) (DEN240031) | Prapela, Inc. | 2025-04-04 |
| HeartFocus (V.1.1.1) (K242807) | Deski | 2025-04-04 |
| Philips VSC-MEDlib (K242001) | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (K243786) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (K250727) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| DeepFoqus (DeepFoqus-Accelerate) (K241982) | Foqus Technologies, Inc. | 2025-04-04 |
| Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706) | Biotronik, Inc. | 2025-04-04 |
| EyeBOX EBX-4.1 (K242116) | Oculogica, Inc. | 2025-04-04 |
| WHOOP ECG (electrocardiogram) Feature (1.0) (K243236) | Whoop., Inc. | 2025-04-04 |
| UASure II Blood Uric Acid Monitoring System (K242209) | Apex BioTechnology Corp. | 2025-04-04 |
| RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (K240398) | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (K242769) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| DeGen Medical Patient Specific Implant (PSI) System (K250667) | Degen Medical | 2025-04-04 |
| Salvo® Robotic Navigation Instruments (K243514) | Spine Wave, Inc. | 2025-04-03 |
| Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (K243298) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-04-03 |
| stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K243936) | Staclear, Inc. | 2025-04-03 |
| SureFine Pen Needle (K250658) | Shina Med Corporation | 2025-04-03 |
| Powered wheelchair (mobility robot) (M4, M4U) (K242358) | Xsto Co., Ltd. | 2025-04-03 |
| Masimo W1 (K243305) | Masimo Corporation | 2025-04-03 |
| syngo Dynamics (Version VA41D) (K242551) | Siemens Healthcare GmbH | 2025-04-03 |
| OSSIOfiber® Suture Anchor 2.5-3.5 mm (K243760) | OSSIO , Ltd. | 2025-04-03 |
| Leos Laser and Endoscopy System (K240615) | Beaver-Visitec International, Inc. | 2025-04-03 |
| LifeShield Infusion Safety Software Suite (K242117) | Icu Medical, Inc. | 2025-04-02 |
| Progenix Select Stim (K242460) | Progenix, LLC | 2025-04-02 |
| SPECTRUM GV Bone Cement (K250760) | Osteoremedies, LLC | 2025-04-02 |
| eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (K250152) | Shenzhen TPH Technology Co., Ltd. | 2025-04-02 |
| Hi-D Imaging 4TAVR (K241984) | Hi-D Imaging AG | 2025-04-02 |
| FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (K243659) | SeaSpine Orthopedics Corporation | 2025-04-02 |
| twiist system (K250930) | Deka Research & Development Corp. | 2025-04-02 |
| Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) (K243889) | Orthocell, Ltd. | 2025-04-02 |
| LEGION Total Knee System (K250677) | Smith & Nephew, Inc. | 2025-04-02 |
| Béa Applicator (BAP-GB-01) (K242031) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 |
| Plum Solo™ Precision IV Pump (K242114) | Icu Medical, Inc. | 2025-04-02 |
| SION blue PLUS (K243733) | Asahi Intecc Co., Ltd. | 2025-04-02 |
| Nerve Wrap (07-DW-001-TAB) (K242113) | Biocircuit Technologies, Inc. | 2025-04-02 |
| VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (K242067) | Olympus Corporations of the Americas | 2025-04-02 |
| Plum Duo™ Precision IV Pump (K242115) | Icu Medical, Inc. | 2025-04-02 |
| SnapHammer Hammertoe Correction System (K250613) | Nvision Biomedical Technologies, Inc. | 2025-04-02 |
| Small Volume 0.2mL Syringe (K250138) | Prosum Medical Limited | 2025-04-02 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K250705) | Gynesonics, Inc. | 2025-04-02 |
| AdvaTx (K250189) | Advalight Aps | 2025-04-01 |
| Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (K250623) | OrthoPediatrics Corp. | 2025-04-01 |
| SABA Tampons (K242105) | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 |
| MR Contour DL (K242925) | GE Healthcare | 2025-04-01 |
| STOPWET iontophoresis apparatus (SW01) (K242041) | Taiwan Medical Electronics Co., Ltd. | 2025-04-01 |
| Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (K250578) | Careglove Global Sdn. Bhd. | 2025-04-01 |
| Medical Diode Laser Systems (THEIA808) (K250018) | Gigaalaser Company , Ltd. | 2025-04-01 |
| da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K242427) | Intuitive Surgical, Inc. | 2025-04-01 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (K243938) | Scientia Vascular, Inc. | 2025-04-01 |
| Préime DermaFacial (MicroT) (K243072) | EMA Aesthetics , Ltd. | 2025-04-01 |
| Disposable Grasping Forceps FG-52D/FG-54D (K250263) | Olympus Medical Systems Corp. | 2025-03-31 |
| TribusConnect (K242166) | Tribusmed Beheer BV | 2025-03-31 |
| Denture Base Resin DT20 (K250946) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 |
| Belzer UW® Cold Storage Solution (BTLBUW-001) (K243384) | Bridge TO Life | 2025-03-31 |
| Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (K250663) | Taewoong Medical Co., Ltd. | 2025-03-31 |
| Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (K243178) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-03-31 |
| Layer 7-T (K242618) | Precision Neuroscience, Corp. | 2025-03-30 |
| Neuro Omega System; NeuroSmart System (K250601) | Alpha Omega Engineering , Ltd. | 2025-03-30 |
| Arthrex FiberTak Suture Anchor (K250596) | Arthrex, Inc. | 2025-03-28 |
| Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (K244030) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 |
| Visby Medical Women's Sexual Health Test (DEN240020) | Visby Medical, Inc. | 2025-03-28 |