| Wrist Fracture System (K251732) | Met One Technologies, LLC | 2026-02-12 |
| Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (K252490) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201) | 4Web, Inc. | 2026-02-12 |
| Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (K253381) | Medtronic Navigation, Inc. | 2026-02-12 |
| PuraCath Firefly Needleless Connector IT (9005) (K251375) | Puracath Medical, Inc. | 2026-02-12 |
| Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (K252523) | Healgen Scientific,, LLC | 2026-02-12 |
| IMAGE1 (TC400US); X-to-4U Adapter (TC040) (K253972) | Karl Storz SE & CO. KG | 2026-02-12 |
| LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (K254007) | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 |
| ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) | Roche Diagnostics | 2026-02-12 |
| L12 LED Light Source with AIM (K260108) | Stryker Endoscopy | 2026-02-12 |
| Delivery Date AI (DEN250007) | Ultrasound AI | 2026-02-11 |
| CURIS II RF Generator (REF 360100-05) (K251813) | Sutter Medizintechnik GmbH | 2026-02-11 |
| AI4CMR v2.0 (K252084) | Ai4medimaging Medical Solutions S.A. | 2026-02-11 |
| iFuse INTRA Ti™ Implant System (K253488) | SI-BONE, Inc. | 2026-02-11 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
| Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (K253049) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-02-11 |
| SteriHub™ Disinfecting Device and Protective Cover (K251592) | 1World Vista Medical | 2026-02-11 |
| ArmSure Fluoroscopic Positioning System (K251992) | Savfe Co. , Ltd. | 2026-02-11 |
| Solidex® Ti-Links and Screws (K251515) | CreoDent Hudson Valley | 2026-02-10 |
| GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only (K252179) | Shenzhen RF Tech Co., Ltd. | 2026-02-10 |
| Earflo (EF001) (K252751) | Earflo, Inc. | 2026-02-10 |
| Vulcan Spinal System (K253545) | K2m, Inc. | 2026-02-10 |
| CollOvine™ Wound Powder (K253140) | Ovigenex, LLC | 2026-02-10 |
| LANDR Contact LENS Case (K252175) | Fourth Axis, LLC | 2026-02-10 |
| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (K251672) | Medtronic Xomed, Inc. | 2026-02-10 |
| multiFlux 130 (F00013123); multiFlux 160 (F00013124) (K252459) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 |
| MI View&GO (K254016) | Siemens Medical Solutions USA, Inc. | 2026-02-10 |
| XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (K260073) | Biodynamik, Inc. | 2026-02-10 |
| Peel-Away Introducer Sheath (K254236) | VascuTech Medical, LLC | 2026-02-09 |
| Holter ECG and ABP system (HolterABP) (K251591) | Edan Instruments, Inc. | 2026-02-09 |
| Ceribell Instant EEG Headset (K254033) | Ceribell, Inc. | 2026-02-09 |
| LAIA XR (K251577) | Augmented Reality Software S.L. | 2026-02-06 |
| LiveMedica Enterprise PACS (K253927) | Live Medica, LLC | 2026-02-06 |
| Athelas Home (K243348) | Athelas, Inc. | 2026-02-06 |
| Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (K252871) | Stryker Leibinger GmbH & Co KG | 2026-02-06 |
| SafeBeat Rx App (K251218) | SafeBeat Rx, Inc. | 2026-02-06 |
| Q Interbody Instruments (K252873) | K2m, Inc. | 2026-02-06 |
| INTEGRE LIO (K251507) | Quantel Medical | 2026-02-06 |
| Spectra S1 Pro; Spectra S2 Pro (K251423) | Uzinmedicare Co., Ltd. | 2026-02-06 |
| Stainless Steel Surgical Kits (K251614) | Dentsply Sirona, Inc. | 2026-02-06 |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) (K251474) | Median Technologies | 2026-02-06 |
| SIGNA™ Bolt (K253780) | Ge Medical Systems, LLC | 2026-02-06 |
| MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852) | ETHICON, Inc. | 2026-02-06 |
| Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (K253221) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| Aptiva APS IgA Reagent (K243979) | Inova Diagnostics, Inc. | 2026-02-06 |
| IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (K252726) | Philips Medizin Systeme Boeblingen GmbH | 2026-02-06 |
| Kneevoice Cartilage Evaluation System (750-3600-001) (K252076) | Kneevoice, Inc. | 2026-02-06 |
| Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (K253568) | Fujifilm Corporation | 2026-02-06 |
| Dermatrix Duo (K251836) | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |
| ROSA Knee System with UltraSound Imaging Platform (USIP) (K252058) | Balmoral Medical, LLC | 2026-02-06 |
| Amferia Wound Dressing (DEN250006) | Amferia AB | 2026-02-06 |
| Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (K260028) | Argon Medical Devices, Inc. | 2026-02-05 |
| INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (K251949) | Penumbra, Inc. | 2026-02-05 |
| Encora X1 (K251517) | Encora, Inc. | 2026-02-05 |
| SIGNA™ Sprint Select (K253779) | Ge Medical Systems, LLC | 2026-02-05 |
| Primevision 3D (K253959) | Dentsply Sirona | 2026-02-05 |
| Luna® Ti Interbody Fusion System (K250773) | Spinal Elements, Inc. | 2026-02-04 |
| UltraScore™ Focused Force PTA Balloon (K260012) | Bard Peripheral Vascular, Inc. | 2026-02-04 |
| Henan Yadu Level 4 Surgical Gowns (Reinforced) (K252301) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |
| E3D™-C Interbody System (K260038) | Evolution Spine | 2026-02-04 |
| Signature™ ONE System (K260104) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 |
| ZSmile System (K253282) | Dror Orthodesign , Ltd. | 2026-02-03 |
| The Circadia C300 System (C300) (K252676) | Circadia Health, Inc. | 2026-02-03 |
| 808nm semiconductor laser hair removal machine (K252048) | Xi'An Taibo Electronic Technology Co., Ltd. | 2026-02-03 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| Navigation Module of the Cortium® System (K252087) | Ulrich Medical USA, Inc. | 2026-02-03 |
| T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (K253640) | Stryker GmbH | 2026-02-03 |
| Explant Express (K252438) | Applied Medical Technology, Inc. | 2026-02-03 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253737) | Dexcom, Inc. | 2026-02-03 |
| MSS - Monobloc stem (K250644) | Medacta International S.A. | 2026-02-03 |
| Diagnostic X-Ray Equipment Model POCT22 (K252909) | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 |
| Vital Signs (K251200) | Oxehealth Limited | 2026-02-02 |
| BIORES Dental Implant System (K252286) | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
| TAP2D (K252649) | Nano-X Imaging , Ltd. | 2026-02-02 |
| CHIKAI Nexus petit (K252011) | Asahi Intecc Co., Ltd. | 2026-02-02 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (K253847) | Merit Medical Ireland, Ltd. | 2026-01-31 |
| ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (K254290) | Shenzhen Peninsula Medical Group | 2026-01-30 |
| Clungene RSV Antigen Rapid Test (K253318) | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (K253833) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-01-30 |
| Disposable Distal End Tape Hood (K252457) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| BruxZir® Shaded 16 PLUS (K254283) | Prismatik Dentalcraft, Inc. | 2026-01-30 |
| RevealAI-Lung (K251769) | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 |
| Dual Stage Venous Cannulae (K253671) | Sorin Group Italia S.R.L. | 2026-01-30 |
| Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (K250983) | Asistan Medikal | 2026-01-30 |
| Boston PICO (Boston PICO) (K251981) | Boston Aesthetics, Inc. | 2026-01-30 |
| Motor Handpiece and Control Unit (SDI10) (K251407) | Saeshin Precision Co., Ltd. | 2026-01-30 |
| BAROguard Donor Lung Preservation System (K254305) | Paragonix Technologies, Inc. | 2026-01-30 |
| Electric Scooter (DDF100) (K252275) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 |
| Labcorp Fentanyl Urine Visual Test (K252684) | Medtox Diagnostics, Inc. | 2026-01-29 |
| EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (K251274) | HR Healthcare | 2026-01-29 |
| Falco Fusion System (K253611) | Mcnicoll Surgical, Inc. | 2026-01-29 |
| EK MULTI ANGLED 30 ABUTMENT (K251427) | Hiossen, Inc. | 2026-01-29 |
| Medical Shaver System (Morcellator) (YSB-IIIA) (K251923) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| Manual Wheelchair (W50) (K253632) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 |
| Neurophet AQUA AD Plus (K252496) | Neurophet., Inc. | 2026-01-29 |
| Surgical Reality Viewer (K252091) | Medicalvr B.V. | 2026-01-29 |