| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| DeepRESP (K252330) | Nox Medical Ehf | 2025-11-17 |
| PM2™ System with ECGuide™ Connector (K252792) | Piccolo Medical, Inc. | 2025-11-17 |
| TS-RF Generator (STS10) (K251566) | Starmed Co., Ltd. | 2025-11-17 |
| ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System (K253487) | Siemens Medical Solutions USA, Inc. | 2025-11-17 |
| DTX Studio Assist (K252086) | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K251141) | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| Mesh Nebulizer (H6) (K251659) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| Status™ COVID-19/Flu A&B (K251538) | Princeton BioMeditech Corp. | 2025-11-14 |
| ARC-EX System (K251821) | Onward Medical, Inc. | 2025-11-14 |
| IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (K252618) | Alovea Healthcare Co. , Ltd. | 2025-11-14 |
| AquaC UNO H (K250471) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| AutoDensity (K251078) | Eos Imaging | 2025-11-14 |
| Second Opinion® Panoramic (K250525) | Pearl, Inc. | 2025-11-14 |
| Lyme-ID IgG Test; Bio-ID800 (K252627) | Inanovate, Inc. | 2025-11-14 |
| Sterilization Trays (K251756) | Paragon Implant Mfg., LLC | 2025-11-14 |
| Neurolyser XR (NXR100) (DEN250015) | Fusmobile, Inc. | 2025-11-14 |
| Biomoneta Avata Rx (K251872) | Biomoneta Research Private Limited | 2025-11-14 |
| KLS Martin IPS Forearm System (K250865) | KLS-Martin L.P. | 2025-11-14 |
| System Sophi (K250501) | This AG | 2025-11-14 |
| LED Beauty Mask (RLBXX) (K252308) | Atop Lighting Co., Ltd. | 2025-11-13 |
| Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (K251662) | Shenzhen Future Electronic Co., Ltd. | 2025-11-13 |
| Rosa® Knee System (K251314) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 |
| Geminus Volar Distal Radius Plating System (K252949) | Skeletal Dynamics, Inc. | 2025-11-13 |
| Dental Computed Tomography X-ray System (K251842) | Fussen Technology Co., Ltd. | 2025-11-13 |
| TELLTALE Electrosurgical Guidewire System (K252592) | Telltale, LLC | 2025-11-13 |
| ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (K253457) | Siemens Medical Solutions USA, Inc. | 2025-11-13 |
| PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (K243897) | ETHICON, Inc. | 2025-11-12 |
| CMORE® CT System; CMORE® CT System Navigated Instruments (K252327) | Icotec AG | 2025-11-12 |
| Powered Wheelchair (PL001-9001) (K252829) | Suzhou KD Intelligent Device Co., Ltd. | 2025-11-12 |
| WRISTAR MultiAx Distal Radius Kit (K252959) | Intrauma S.P.A | 2025-11-12 |
| Hemoclip (K252271) | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 |
| EMPOWR Acetabular® Liner Extension (K251833) | Encore Medical L.P. | 2025-11-12 |
| PeekMed web (K252452) | Peek Health, S.A. | 2025-11-12 |
| Synthes Patient Specific Implants (K243715) | Synthes GmbH | 2025-11-12 |
| VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (K251336) | Olympus Medical Systems Corp. | 2025-11-12 |
| XSTAT P15 (K253290) | Revmedx, Inc. | 2025-11-12 |
| NeVasc Aspiration System (K251006) | Vesalio, Inc. | 2025-11-10 |
| EzSensor HD, EzSensor UHD (K252570) | Qpix Solutions, Inc. | 2025-11-10 |
| Withings BeamO (SCT02) (K252474) | Withings | 2025-11-10 |
| IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (K251702) | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 |
| Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (K252560) | Atlas Spine, Inc. | 2025-11-10 |
| Symani Surgical System (K252287) | Medical Microinstruments, Inc. | 2025-11-10 |
| KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (K252573) | KLS-Martin L.P. | 2025-11-10 |
| Lunderquist Extra Stiff Wire Guide (K251596) | William Cook Europe Aps | 2025-11-09 |
| Primeprint Direct Aligner (K250739) | Dreve Dentamid GmbH | 2025-11-07 |
| MultiMatch Flow Chameleon AntiMicrobial Composite (K253513) | Premier Dental Products Company | 2025-11-07 |
| S.I.N. Tapered Pro Conical Zygoma Implant System (K251129) | S.I.N. Implant System Ltda | 2025-11-07 |
| Electric Wheelchair (Rollz Motion Electric 2M) (K250819) | Rollz International BV | 2025-11-07 |
| ulrichINJECT CT Motion (XD 8000) (K251295) | Ulrich GmbH & Co. KG | 2025-11-07 |
| AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (K253039) | Topcon Corporation | 2025-11-07 |
| Fibresolve (with PCCP) (K252041) | Imvaria, Inc. | 2025-11-07 |
| SugarBug (1.x) (K250264) | Bench7, Inc. | 2025-11-07 |
| Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (K251441) | Inion OY | 2025-11-07 |
| Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (K251853) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-11-07 |
| BrainsWay Deep TMS System (K251391) | Brainsway , Ltd. | 2025-11-07 |
| Triathlon Pro (K243131) | Sigma Biomedical | 2025-11-07 |
| Medical Diode Laser Systems (VeinCure) (K252564) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-07 |
| CO2 Laser Therapy System (K106) (K252519) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-07 |
| mb-FIX Cranial Stabilization Systems (K250423) | Medical Bees GmbH | 2025-11-06 |
| Motive™ Muscle Stimulator for Lower Back (OT01-1003) (K253478) | Motive Health, Inc. | 2025-11-06 |
| Hubly Drill (H100) (K250815) | Hubly, Inc. | 2025-11-06 |
| BriefCase-Triage (K253265) | Aidoc Medical , Ltd. | 2025-11-06 |
| Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (K251004) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (K252469) | Dmp Dental Industry S.A. | 2025-11-06 |
| Tandem Mobi insulin pump with interoperable technology (K253074) | Tandem Diabetes Care, Inc. | 2025-11-06 |
| AIO Breathe (K252525) | Aiomega, LLC | 2025-11-06 |
| Q-Switched Nd:Yag laser (K690) (K252515) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-06 |
| Catalyst F1x Shoulder System (K252418) | Catalyst Orthoscience, Inc. | 2025-11-06 |
| Ultra™ Compression Screw System (K251555) | Pace Surgical | 2025-11-06 |
| Adaptix Ortho350 (K252133) | Adaptix Limited | 2025-11-06 |
| Venus Nova (FP-2001) (K252845) | Venus Concept, Inc. | 2025-11-06 |
| Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792) | Stereotaxis, Inc. | 2025-11-06 |
| Polyshield Safety IV Catheters (K252677) | Poly Medicure Limited | 2025-11-05 |
| EVAC-MRI (K252514) | Phasor Health, LLC | 2025-11-05 |
| Allure Hip Stem and Intramedullary Plugs (K250375) | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept (K250363) | Beijing Sinovation Medical Technology Co., Ltd. | 2025-11-05 |
| ViVY (K250376) | Viatherm Therapeutics, LLC | 2025-11-05 |
| ExcelsiusGPS™ Instruments (K250599) | Globus Medical, Inc. | 2025-11-05 |
| Cios Select (K250241) | Siemens Medical Solutions USA, Inc. | 2025-11-04 |
| VXvue (K251410) | Vieworks Co., Ltd. | 2025-11-04 |
| Merit Syringe (K250853) | Merit Medical Systems, Inc. | 2025-11-04 |
| GMReis Suture Anchors (K252664) | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 |
| MedCAD® AccuStride™ System (K251709) | Medcad | 2025-11-04 |
| Tamburo Thulium Fiber Laser System (K251303) | Menovex Medical Technology (Shenzhen) Co., Ltd. | 2025-11-04 |
| PRIMED Surgical and Procedure Masks (K252964) | Primed Medical Products, Inc. | 2025-11-04 |
| Flexx Junior (FLX-J00, FLX-J50) (K250576) | Karma Mobility Co, Ltd. | 2025-11-04 |
| Voyant® Open Fusion Device (EB240/Open Fusion) (K252740) | Applied Medical Resources Corp. | 2025-11-04 |
| Electric wheelchair (NSDS-01) (K252671) | Hebei Dansong Medical Technology Co., Ltd. | 2025-11-03 |
| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| Sonosite MT Ultrasound System (K253448) | FUJIFILM Sonosite, Inc. | 2025-11-03 |
| NightGuard Aire Max (K252698) | Nightguard Express, LLC | 2025-11-03 |
| Midmark Dental Delivery System (K251626) | Midmark Corporation | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| ZAP-X Radiosurgery System (ZAP-X) (K250392) | Zap Surgical Systems, Inc. | 2025-11-03 |
| 3mensio Workstation (K250330) | Pie Medical Imaging BV | 2025-11-03 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K251532) | Mighty Oak Medical | 2025-11-03 |
| Kyphoplasty Balloon Dilatation Catheters (K252458) | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (K250917) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 |
| GREEN (K252060) | Phasor Health, LLC | 2025-10-31 |