| Genesis Sleep (K252951) | Neurofield, Inc. | 2025-12-31 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (K253305) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 |
| Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (K243627) | Arc Trauma, LLC | 2025-12-31 |
| MOLLI 2 System (K253888) | Stryker Endoscopy | 2025-12-31 |
| Tyber Medical Trauma Screw (K252901) | Tyber Medical, LLC | 2025-12-31 |
| Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (K250168) | Lucas Lifecare | 2025-12-30 |
| Lipids (K251091) | Truvian Health | 2025-12-30 |
| Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (K242492) | Techno-Path Manufacturing , Ltd. | 2025-12-30 |
| Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (K253895) | Arthrex, Inc. | 2025-12-30 |
| TruSPECT Processing Station (K253532) | Spectrum Dynamics Medical, Ltd. | 2025-12-30 |
| AnyScan 3.0 NM Scanner Family (K253844) | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 |
| Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025) | Covidien, LLC | 2025-12-29 |
| Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (K251313) | Covidien, LLC | 2025-12-29 |
| Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (K251123) | Taewoong Medical Co., Ltd. | 2025-12-29 |
| Oxygen Concentrator (J10A) (K251534) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 |
| Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) (K253881) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-12-29 |
| Celebrace Software (K253343) | Celebrace | 2025-12-29 |
| ZipToe™ Hammertoe Fusion System (K253325) | Toetal Solutions | 2025-12-29 |
| Feather/numiere 05 06 07 (05) (K253279) | Heat IN A Click, LLC | 2025-12-24 |
| PICO-K (K253342) | Speclipse, Inc. | 2025-12-24 |
| Hair Regrowth Cap (Model: T-119-HRC) (K253349) | Light Tree Ventures Europe B.V. | 2025-12-24 |
| LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) (K253400) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 |
| UNITY DX (UDX) (K252633) | Cylite Pty. , Ltd. | 2025-12-23 |
| Philips Lumea IPL (K253754) | Philips Consumer Lifestyle B.V. | 2025-12-23 |
| Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) (K253072) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | 2025-12-23 |
| LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (DEN250032) | DiaSorin, Inc. | 2025-12-23 |
| GEN5™ and GEN5+™ 3.3mmD Dental Implants (K252145) | Paragon Implant Mfg., LLC | 2025-12-23 |
| Custom Abutments AS (K253341) | Medentika GmbH | 2025-12-23 |
| OrangeCAD Med Abutments (K253312) | Orangecad Med GmbH | 2025-12-23 |
| AIR Recon DL (K252379) | Ge Medical Systems, LLC | 2025-12-23 |
| OsteoRemedies Hip Spacer System (K253675) | Osteoremedies, LLC | 2025-12-23 |
| NizPlant Dental Implant System (K250476) | Paragon Implant Mfg., LLC | 2025-12-23 |
| ART-Plan+ (v3.1.0) (K253091) | Therapanacea Sas | 2025-12-23 |
| VarioSurg 4 (K254163) | Nakanishi, Inc. | 2025-12-23 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K253567) | Healgen Scientific,, LLC | 2025-12-23 |
| SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (K251991) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (K252493) | Hycor Biomedical | 2025-12-23 |
| Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (K251683) | Bruno Vision Care, LLC | 2025-12-23 |
| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252146) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 |
| Electric Scooter (S202572J, S2060, M2089, S2050) (K252835) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 |
| LIAISON NES FLU A/B, RSV & COVID-19 (K251978) | Diasorin Molecular, LLC | 2025-12-23 |
| VEINOPLUS Back (K251958) | Dynapulse Medical | 2025-12-23 |
| TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (K253740) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 |
| Active-V Total Knee System; World Total Knee System (K253239) | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (K251268) | Edan Instruments, Inc. | 2025-12-23 |
| LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) (K253135) | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 |
| Sim&Size (K253122) | Sim&Cure | 2025-12-23 |
| QIKCAP System (DEN250004) | Hai Solutions | 2025-12-23 |
| Aura Glide (FC40) (K252187) | Aura Medical, LLC | 2025-12-23 |
| UpDoc (K253281) | Updoc, Inc. | 2025-12-23 |
| MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (K253217) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| KP Protective Face Mask (K243342) | Kp Trading Co., Ltd. | 2025-12-22 |
| Pression Wave PRO External Counter-Pulsation System (K250756) | Pression, Inc. | 2025-12-22 |
| BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (K251019) | Bioteque Corporation | 2025-12-22 |
| Oxygen Concentrator-P2-O5E (K251764) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 |
| Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783) | Sorin Group Italia S.R.L. | 2025-12-22 |
| Tetra (TM-20); Tetra (TM-50) (K251105) | Emed Technologies Corporation | 2025-12-22 |
| MC2 Portable X-ray System (K252068) | Oxos Medical | 2025-12-22 |
| STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743) | ETHICON, Inc. | 2025-12-22 |
| Lumify Diagnostic Ultrasound System (K252557) | Philips Ultrasound, LLC | 2025-12-22 |
| PeekMed web (K252856) | Peek Health, S.A. | 2025-12-22 |
| HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) | Globus Medical, Inc. | 2025-12-22 |
| AccurECG Analysis System (v2.0) (K252361) | Accurkardia, Inc. | 2025-12-22 |
| aprevo® cervical plating system (K252611) | Carlsmed, Inc. | 2025-12-22 |
| Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (K253222) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025-12-22 |
| Theracor (K253339) | Stimlabs, LLC | 2025-12-22 |
| BioticsAI (K250959) | Bioticsai, Inc. | 2025-12-22 |
| Portable oxygen concentrator (JLO-190P) (K252616) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 |
| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| InnoClip Disposable Clip Applier (K253903) | Taiwan Surgical Corporation | 2025-12-22 |
| Syndesmosis TightRope PRO (K253727) | Arthrex, Inc. | 2025-12-22 |
| TMINI Miniature Robotic System (K253661) | THINK Surgical, Inc. | 2025-12-22 |
| Instylla Delivery Kit (K253769) | Instylla, Inc. | 2025-12-22 |
| Power wheelchair (K251159) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2025-12-22 |
| DIMPLO Implant System (K251605) | DIMPLO, Ltd. | 2025-12-22 |
| SKOUT system (K253664) | Iterative Health | 2025-12-22 |
| InnoClip Clip Applier (K253781) | Taiwan Surgical Corporation | 2025-12-22 |
| LacertaMatrix (K252673) | Lacerta Life Science | 2025-12-22 |
| EmbraceMini (K252981) | Empatica S.r.l. | 2025-12-22 |
| Airbile-100 (K250976) | Poskom Co., Ltd. | 2025-12-19 |
| LIA-1 Catheter (542-1) (K251402) | Leadoptik, Inc. | 2025-12-19 |
| AI-CVD (K252029) | HeartLung Corporation | 2025-12-19 |
| MSFX MIKRON PEEK CAGES (K252781) | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 |
| Rectal Applicator (K251037) | Nucletron B.V. | 2025-12-19 |
| Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (K252167) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| LED Light Therapy Device (Models: SG-FM, SG-FE) (K253086) | Sunglor Technology Co., Ltd. | 2025-12-19 |
| LCD Monitor (CL1902A, CL2103F) (K252780) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-12-19 |
| SCOUT MD Surgical Guidance System (K252892) | Merit Medical Systems, Inc. | 2025-12-19 |
| Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (K251143) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2025-12-19 |
| SANDRO Dual (K252877) | Wontech Co., Ltd. | 2025-12-19 |
| Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (K252342) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 |
| DBLG2 (K251152) | Diabeloop | 2025-12-19 |
| eRapid with eTrack System (K251572) | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| Alzevita (K252670) | TOPIA MEDTECH LIMITED | 2025-12-19 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| MatriDerm pluS+ Bi-Layer (K250864) | Medskin Solutions Dr. Suwelack AG | 2025-12-19 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |
| Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (K250314) | Surgical Instrument Service and Savings, Inc. | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |