| iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr (K251113) | Andon Health Co, Ltd. | 2025-08-04 |
| Terragene® Bionova® BT20 Biological Indicator (K251122) | Terragene | 2025-08-04 |
| Blood Volume Analyzer (200) (K251087) | Daxor Corporation | 2025-08-04 |
| Equinoxe® Shoulder System (K243448) | Exactech, Inc. | 2025-08-01 |
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |
| IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) (K251707) | Shenzhen Huachuangtong Industrial Co., Ltd. | 2025-08-01 |
| MycoMEIA Aspergillus Assay (K243496) | Pearl Diagnostics, Inc. | 2025-08-01 |
| Revolution Vibe (K250941) | Ge Medical Systems, LLC | 2025-08-01 |
| RONAVIS – FX (FX-001) (K250315) | AIRS, Inc. | 2025-08-01 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (K251652) | American Medical Endoscopy, Inc. | 2025-08-01 |
| eZSURE™ Empty Fluid Container (K252094) | Epic Medical Pte. , Ltd. | 2025-08-01 |
| MINI VP1 (PL67_F); MINI VP1 (PL61_F) (K250495) | Avizor S.A. | 2025-08-01 |
| Diazyme Colorimetric Lithium Assay (K243462) | Diazyme Laboratories, Inc. | 2025-08-01 |
| INNOVISION-DXII (K250790) | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541) | GI Windows, Inc. | 2025-08-01 |
| NOBILCAM IMPAK Disc (K251252) | Shandong Huge Dental Material Corporation | 2025-08-01 |
| QuickSleeper 5 (K243427) | Dentalhitec | 2025-08-01 |
| Sparta Infusion Set for Insulin (K243841) | Deka Research and Development | 2025-08-01 |
| Deepsight NeedleVue LC1 Ultrasound System (K250381) | DeepSight Technology, Inc. | 2025-08-01 |
| HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (K243458) | Access Vascular, Inc. | 2025-08-01 |
| Access hsTnI (K243483) | Beckman Coulter, Inc. | 2025-08-01 |
| Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571) | Zimmer Biomet | 2025-07-31 |
| ArteraAI Prostate (DEN240068) | Artera, Inc. | 2025-07-31 |
| eCO2 3D (K244060) | Lutronic Corporation | 2025-07-31 |
| Sleep Watch (K251574) | Ambulatory Monitoring, Inc. | 2025-07-31 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |
| Biograph Trinion (K251561) | Siemens Medical Solutions USA, Inc. | 2025-07-31 |
| REMEX Xcam6 (K250597) | Remedi, Inc. | 2025-07-31 |
| BeneVision Central Monitoring System (K242728) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656) | United Orthopedic Corporation | 2025-07-31 |
| Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (K250843) | Shenzhen TPH Technology Co., Ltd. | 2025-07-31 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Mpact Constrained Liner (K241461) | Medacta International S.A. | 2025-07-31 |
| NextAR(TM) Spine (K250477) | Medacta International S.A. | 2025-07-31 |
| YSIO X.pree (K250738) | Siemens Medical Solutions | 2025-07-31 |
| ArteVu (K244007) | Cardio Ring Technologies, Inc. Taiwan Branch | 2025-07-30 |
| Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735) | Acuity Surgical Devices, LLC | 2025-07-30 |
| SpineSite Endoscope System (K241990) | Hydrocision, Inc. | 2025-07-30 |
| P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K242855) | E.O.S Co., Ltd. | 2025-07-30 |
| Voxel Dosimetry (00859873006226) (K243919) | Hermes Medical Solutions AB | 2025-07-30 |
| Intraosseous Infusion Needles (K250724) | Spectrum Vascular | 2025-07-30 |
| T65 (9016E061-) (K252032) | Tonica Elektronik A/S | 2025-07-30 |
| CORUS™ Navigation System-GX (K251060) | Providence Medical Technology, Inc. | 2025-07-30 |
| TENS and EMS Unit (K251706) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| Tyber Medical Distal Radius Plating System (K251361) | Tyber Medical, LLC | 2025-07-30 |
| EnSite™ X EP System (K251234) | ABBOTT MEDICAL | 2025-07-30 |
| Iconix Speed Anchor; Iconix Speed HA+ Anchor (K252144) | Riverpoint Medical | 2025-07-30 |
| Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) (K251076) | Shenzhen Lifotronic Technology Co., Ltd. | 2025-07-30 |
| TSK Syringe (K250127) | Tsk Laboratory, Japan | 2025-07-30 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff (K251319) | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| Micro Catheter (K243534) | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| Cios Spin (K251523) | Siemens Medical Solutions USA, Inc. | 2025-07-29 |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) | Infobionic, Inc. | 2025-07-29 |
| BD Plastipak™ Syringe (K251350) | Becton, Dickinson and Company | 2025-07-29 |
| Sleepiz One+ (2.5) (K251364) | Sleepiz AG | 2025-07-29 |
| Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (K250179) | Edan Instruments, Inc. | 2025-07-29 |
| PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (K243473) | Prognosys Medical Systems Private Limited | 2025-07-29 |
| Forcyte Autograft Harvest Kit (K243407) | Forcyte Medical, LLC | 2025-07-29 |
| Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664) | Olympus Medical Systems Corporation | 2025-07-29 |
| da Vinci Surgical System, IS5000 (K250442) | Intuitive Surgical, Inc. | 2025-07-29 |
| SImmetry+ System (K250647) | Sivantage | 2025-07-29 |
| SIGMA Spectrum Infusion Pump with Master Drug Library (K251640) | Baxter Healthcare Corporation | 2025-07-28 |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (K250652) | Anumana, Inc. | 2025-07-28 |
| NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K251061) | Siemens Medical Solutions USA, Inc. | 2025-07-28 |
| NUVENTUS NV.C™ Prosthetic Components (K251220) | Infinitum Eta, Ltd. | 2025-07-28 |
| Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) | Baxter Healthcare Corporation | 2025-07-28 |
| ISO Abutment (K241183) | Seum Medi Co., Ltd. | 2025-07-28 |
| 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (K251187) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-28 |
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| Heated Breathing Tube (K243244) | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| Compression Therapy Device (LGT-2210DS) (K250244) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-07-25 |
| BD Nexiva™ Closed IV Catheter System (K243403) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 |
| Triathlon® Hinge Knee System (K251665) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 |
| Venue; Venue Go; Venue Fit; Venue Sprint (K251322) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-25 |
| Vathin® Video Bronchoscope System (K250232) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859) | Genesee Biomedical, Inc. | 2025-07-25 |
| Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033) | CMT Health PTE., Ltd. | 2025-07-25 |
| A.L.P.S. Proximal Humerus Plating System (K251620) | Zimmer Biomet | 2025-07-25 |
| Fusion Craniofacial Implant; Fusion Skull Implant (K250334) | Kelyniam Global, Inc. | 2025-07-25 |
| Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (K251339) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-07-25 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552) | ABBOTT MEDICAL | 2025-07-25 |
| InbellaMAX System (K252215) | Inbella Medical , Ltd. | 2025-07-25 |
| Stryker and Serf hip devices (K250989) | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| Marie (K250970) | Leo Cancer Care | 2025-07-25 |
| SPY Laparoscope (K252010) | Stryker Endoscopy | 2025-07-24 |
| TSK SELECT™ Needle (K250284) | Tsk Laboratory, Japan | 2025-07-24 |
| Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392) | B.Braun Medical, Inc. | 2025-07-24 |
| MOTO Partial Knee System Extension (K251618) | Medacta International S.A. | 2025-07-24 |
| Respond OC Conserving Regulator (130-0800) (K250322) | Responsive Respiratory | 2025-07-24 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251455) | Philips Ultrasound, LLC | 2025-07-24 |
| HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (K251984) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-07-24 |
| Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (K243711) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 |
| Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056) | AtriCure, Inc. | 2025-07-24 |
| Onflex™ Mesh (K251955) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| MIS LYNX Conical Connection Implant System (K251297) | Dentsply Sirona, Inc. | 2025-07-24 |
| IMAGE ONE (K250716) | Infomed Software, S.L. | 2025-07-23 |
| MammoSTAR Biopsy Site Identifier (K251748) | Carbon Medical Technologies, Inc. | 2025-07-23 |
| MAGiC Sweep™ EP Mapping Catheter (K250590) | Stereotaxis, Inc. | 2025-07-23 |
| HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (K243781) | Edwards Lifesciences | 2025-07-23 |