| Optilume® High Pressure Urological Balloon Dilation Catheter (K250910) | Urotronic, Inc. | 2025-05-22 |
| TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (K250935) | TriMed, Inc. | 2025-05-22 |
| Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K250630) | Basic Medical Technology, Inc. | 2025-05-22 |
| Trivicta® Hip Stem (K251052) | Ortho Development Corp. | 2025-05-22 |
| ConcizuTrace™ ELISA (DEN240035) | Randox Laboratories, Ltd. | 2025-05-22 |
| Arthrex Spine Compression FT Screw (K250920) | Arthrex, Inc. | 2025-05-22 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659) | Thermo Fisher Scientific | 2025-05-22 |
| DESS Dental Smart Solutions (K250639) | Terrats Medical SL | 2025-05-22 |
| Physica System (Physica CR Porous Femoral components) (K250980) | Lima Corporate S.P.A. | 2025-05-22 |
| ArgoCap (200.52) (K242586) | Ovesco Endoscopy AG | 2025-05-22 |
| HJY VisualNext 3D Endoscopic Vision System (K243429) | Hjy Smart Medical Device Co., Ltd. | 2025-05-21 |
| FlareHawk Interbody Fusion System (K243116) | Integrity Implants Inc. Dba Accelus | 2025-05-21 |
| ClearHemograsper (K242857) | Finemedix Co., Ltd. | 2025-05-21 |
| MEM Clear Aligner System (K242637) | Mem Dental Technology Co., Ltd. | 2025-05-21 |
| Control-IQ+ technology (K250798) | Tandem Diabetes Care, Inc. | 2025-05-21 |
| The Karma® Fixation System (K242527) | Spinal Elements, Inc. | 2025-05-21 |
| MotiliCap GI Monitoring System (K250493) | Anx Robotica Corporation | 2025-05-21 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243793) | Philips Ultrasound, LLC | 2025-05-21 |
| uMR Omega (K243122) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 |
| Stryker AlphaVent™ Knotless SP Biocomposite Anchor (K250528) | Stryker Endoscopy | 2025-05-21 |
| Synapse 3D Base Tools (V7.0) (K243762) | Fujifilm Corporation | 2025-05-21 |
| InVision Precision Cardiac Amyloid (K243866) | InVision Medical Technology Corporation | 2025-05-21 |
| Swoop® Portable MR Imaging® System (K251276) | Hyperfine, Inc. | 2025-05-21 |
| The Alma Hybrid Laser System (K251230) | Alma Lasers, Inc. | 2025-05-21 |
| SMARTDent (K251109) | Ray Co., Ltd. | 2025-05-21 |
| GrandioSO Unlimited (K251239) | Voco GmbH | 2025-05-21 |
| 3DMatrix DynaFlex (DynaFlex) (K243302) | Printbio, Inc. | 2025-05-21 |
| X-PAC® N-GAGE™ Lumbar Plate System (K250602) | Expanding Innovations, Inc. | 2025-05-20 |
| VitalFlow Console (K250199) | Medtronic, Inc. | 2025-05-20 |
| Sovereign Posterior Cervical System (K250866) | Met One Technologies, LLC | 2025-05-20 |
| EveryWare (K242485) | Breas Medical AB | 2025-05-20 |
| Biomic Color Opaque (K250534) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 |
| ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231) | ABBOTT MEDICAL | 2025-05-20 |
| SCENARIA View Phase 5.0 (K250370) | Fujifilm Corporation | 2025-05-20 |
| FP3D (K250489) | Keystone Industries | 2025-05-20 |
| ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (K250243) | Flexicare Medical Limited. | 2025-05-20 |
| AirFit F20 Mask System; AirFit F20 NM Mask System (K242547) | Resmed Pty , Ltd. | 2025-05-19 |
| MapRT (K243301) | Vision Rt, Ltd. | 2025-05-19 |
| Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (K242755) | Gigaalaser Company , Ltd. | 2025-05-19 |
| restor3d Reverse Total Shoulder Arthroplasty System (K243643) | Restor3D | 2025-05-19 |
| CloSYS® Dry Mouth Sensitive Mouth Rinse (K250390) | Rowpar Pharmaceuticals, Inc. | 2025-05-19 |
| Diagnostic X-ray System (K243411) | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 |
| Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601) | Route 92 Medical, Inc. | 2025-05-19 |
| Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (K250020) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-19 |
| Muscle Stimulator Device (PZ-100) (K250038) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| Dentemp Pro-Comfort Dental Guard (K250456) | Doc Brands, Inc. | 2025-05-19 |
| SleepRight Snore Aid (K250122) | Splintek, Inc. | 2025-05-19 |
| BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447) | Becton, Dickinson and Company | 2025-05-19 |
| InferRead Lung CT.AI (K240554) | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| Mobius3D (4.1) (K250099) | Varian Medical Systems | 2025-05-16 |
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) | Fujirebio Diagnostics,Inc. | 2025-05-16 |
| Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (K244033) | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 |
| MasteRad MiniX Mobile Digital Imaging System (Mini-X) (K242731) | Medicatech USA, Inc. | 2025-05-16 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671) | Esaote, S.p.A. | 2025-05-16 |
| Arthrex Spine Endoscope (K243602) | Arthrex, Inc. | 2025-05-16 |
| OTS Hip (K250086) | Ortoma AB | 2025-05-16 |
| BLESSING System (K243176) | Cellah Medical Co., Ltd. | 2025-05-16 |
| Mixed Reality Spine Navigation (K242569) | Brainlab AG | 2025-05-16 |
| Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371) | Byonyks Pvt, Ltd. | 2025-05-16 |
| Synthecure Synthetic Calcium Sulfate (K250141) | Austin Medical Ventures, Inc. | 2025-05-16 |
| MobileLink Acetabular Cup System - inhouse coatings (K243927) | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (K243617) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 |
| iBSM (K243837) | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
| Cystatin C (K242585) | SENTINEL CH. SpA | 2025-05-16 |
| Clearo (K242438) | Breas Medical AB | 2025-05-16 |
| Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (K250110) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-16 |
| Ruby Intravascular Catheter (K243105) | Venocare, Inc. | 2025-05-16 |
| Spectral CT (K244008) | Philips Medical Systems Technologies , Ltd. | 2025-05-16 |
| AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (K251184) | Encore Medical L.P. | 2025-05-16 |
| Hemodialysis Catheter (K241581) | Haolang Medical USA Corporation | 2025-05-16 |
| Lumify Diagnostic Ultrasound System (K242519) | Philips Ultrasound | 2025-05-15 |
| Limfa Therapy System (Limfa Therapy) (K243165) | Eywa Srl | 2025-05-15 |
| HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (K250454) | Hardy Diagnostics | 2025-05-15 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (K251186) | C.R. Bard, Inc. | 2025-05-15 |
| HFT750U (K242931) | Mekics Co., Ltd. | 2025-05-15 |
| Nitinol Enhanced Device (NED) (K250276) | Embolization, Inc. | 2025-05-15 |
| DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (K242155) | NIKKISO CO., LTD. | 2025-05-15 |
| NPseal (K251156) | Guard Medical, Inc. | 2025-05-15 |
| Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (K250432) | Olympus Medical Systems Corporation | 2025-05-15 |
| OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (K250213) | Stryker Instruments | 2025-05-15 |
| NEXUS® Hip Stem (K250444) | Microport Orthopedics, Inc. | 2025-05-15 |
| NeurAxis IB-Stim (01-1020) (K250451) | Neuraxis | 2025-05-15 |
| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (K242176) | NIKKISO CO., LTD. | 2025-05-15 |
| Youmagic FLM System (YM5-U1) (K240857) | We Medical Technology (Wuxi) Co., Ltd. | 2025-05-15 |
| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (K242479) | NIKKISO CO., LTD. | 2025-05-15 |
| Linkt Compression Staple System (K250712) | Trax Surgical | 2025-05-14 |
| Nerivio; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |
| Magnesium alloy scooter (RS100) (K250533) | Taizhou Reach Technology Co., Ltd. | 2025-05-14 |
| CaloPix (K250414) | Tribun Health | 2025-05-14 |
| Disposable ureteral stent (K243830) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 |
| Smile Dx® (K242437) | Cube Click, Inc. | 2025-05-14 |
| MICROLET®NEXT 2 Lancing Device (K250813) | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 |
| Medical Picosecond ND: YAG Laser System (PZ-6) (K250041) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-14 |
| Medical Image Post-processing Software (uOmnispace.CT) (K242624) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 |
| Helios Dura Regeneration Matrix (K250420) | Helios Biomedical, Inc. | 2025-05-14 |
| ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) (K250835) | Ethicon Endo-Surgery, LLC | 2025-05-14 |
| Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (K250775) | Imperative Care, Inc. | 2025-05-14 |
| Veincare (K251288) | Wontech Co., Ltd. | 2025-05-14 |