| BreathePal Bilevel (GFM50-MD2201) (K252078) | Compal Electronics, Inc. | 2026-03-17 |
| Q Pedicle Instruments (K260546) | K2m, Inc. | 2026-03-17 |
| Super Upper Limbs Versalock Plating System (K260390) | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) (K252971) | C.R. Bard, Inc. | 2026-03-17 |
| MDx-Chex for BCY (K254167) | Streck, LLC | 2026-03-17 |
| Cala kIQ Plus (K253587) | Cala Health, Inc. | 2026-03-17 |
| LASER THERMAL THERAPY KIT (K260632) | Elesta S.P.A | 2026-03-17 |
| Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447) | Orthocon, Inc. | 2026-03-16 |
| Lifemotion Disposable Membrane Oxygenator (K253838) | Lifemotion Medical Technology Co., Ltd. | 2026-03-16 |
| Healgen® Accurate Oral Fluid Drug Test (K253705) | Healgen Scientific,, LLC | 2026-03-16 |
| CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (K254045) | CarboFix Orthopedics , Ltd. | 2026-03-16 |
| Data Analysis Facilitation Suite (DAFS) (K253944) | Voronoi Health Analytics Incorporated | 2026-03-16 |
| Millipede System (K253590) | Perfuze, Ltd. | 2026-03-16 |
| APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (K253916) | Medartis AG | 2026-03-16 |
| SINEFIX (K254176) | BAAT Medical Products B.V. | 2026-03-16 |
| ZENEX Implant System_Short (R-System) (K253334) | Izenimplant Co., Ltd. | 2026-03-16 |
| DCwire Micro-guidewire (K252122) | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| Sonio Detect (v3) (K252433) | Sonio | 2026-03-16 |
| SurgiCount+ System (K252282) | Stryker Instruments | 2026-03-16 |
| Stealth AXiS™ ENT clinical application (K253395) | Medtronic Navigation, Inc. | 2026-03-16 |
| Ulike Reglow Light Therapy Device (UM10) (K260511) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 |
| LED Light Therapy Mask (Models: T2, RLD10) (K254079) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 |
| Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) (K253581) | Technomed Europe | 2026-03-15 |
| GenBody COVID-19 Ag Home Test (K251916) | Genbody.Inc. | 2026-03-13 |
| New Wave System (K260455) | Zeto, Inc. | 2026-03-13 |
| Aeka Imaging (K253111) | Good Methods Global, Inc. | 2026-03-13 |
| Access anti-HBc IgM (K254059) | Beckman Coulter, Inc. | 2026-03-13 |
| IASIS i2 Relaxation Neurofeedback System (K252923) | Iasis Technologies | 2026-03-13 |
| SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (K253799) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 |
| Embrace Neonatal MRI System (K254277) | Aspect Imaging, Ltd. | 2026-03-13 |
| BARE Wireguided Balloon Dilation Catheter (1235) (K253987) | GIE Medical | 2026-03-13 |
| BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes (K252040) | Becton, Dickinson and Company | 2026-03-13 |
| TheraSphere 360™ Y-90 Management Platform (K260479) | Boston Scientific Corporation | 2026-03-13 |
| OptiMap Catheter - 50mm (OPTI-CATH2-50) (K253205) | Cortex, Inc. | 2026-03-13 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K252385) | Pegavision Corporation | 2026-03-13 |
| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| Niti-S SPAXUS Stent (K252648) | Taewoong Medical Co., Ltd. | 2026-03-13 |
| Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (K253391) | Medtronic Navigation, Inc. | 2026-03-13 |
| Apollo Quattro (APQ-10M) (K253261) | Weero Co., Ltd. | 2026-03-13 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (K260147) | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 |
| Pentacam® Cornea OCT (K251848) | Oculus Optikgeräte GmbH | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Permatage Flowable, Settable Bone Paste (K253732) | Orthocon, Inc. | 2026-03-13 |
| InferCare RECIST (K252261) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-03-13 |
| Mimics Thoracic Planner (K251964) | Materialise NV | 2026-03-12 |
| Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (K252583) | A Cute Baby, Inc. | 2026-03-12 |
| Genadyne ASTRA NPWT (K253429) | Genadyne Biotechnologies, Inc. | 2026-03-12 |
| Deep Capsule® (Deep Capsule US) (K250655) | Digestaid - Artificial Intelligence Development SA | 2026-03-12 |
| Trax EX Anchor (K251750) | Trax Surgical, Inc. | 2026-03-12 |
| Dental X-RAY Unit (AJX200) (K252110) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 |
| Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (K252824) | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| Urocross Expander System (Model Numbers ES2018 and ES3025) (K253525) | Prodeon Medical, Inc. | 2026-03-12 |
| implaFit® short stems (K252401) | Implantcast GmbH | 2026-03-12 |
| Zionic Pro Max (EMS) (K253636) | Termosalud S.L. | 2026-03-12 |
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
| LungFlow Basket Catheter (K254040) | Free Flow Medical, Inc. | 2026-03-12 |
| Power Mobility Scooter (MJMA01, MJMA02) (K253936) | Nanjing Mijo Technology Co., Ltd. | 2026-03-12 |
| Medical Mesh Nebulizer (AirICU Max+) (K251584) | AIRICU, Inc. | 2026-03-12 |
| MEDPOR Customized Implant Kit (K254233) | Stryker Leibinger GmbH & Co KG | 2026-03-12 |
| Taurus Clip (K253734) | Taurus Endoscopy | 2026-03-12 |
| Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (K260453) | Bionit Labs Srl | 2026-03-12 |
| Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (K240934) | Spectrum Medical S.R.L. | 2026-03-12 |
| Tyto Stethoscope (G3) (K252089) | Tyto Care , Ltd. | 2026-03-12 |
| Liv Pre-lubricated Intermittent Catheter (K260502) | HR Healthcare | 2026-03-12 |
| VantageTM Lumbar Decompression Kit (K252546) | Allevion Medical, LLC | 2026-03-12 |
| Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (K252541) | Spectrum Medical S.R.L. | 2026-03-12 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Tigertriever 25 Revascularization Device (K253062) | Rapid Medical Ltd. | 2026-03-12 |
| InVera Infusion Device (K250794) | Invera Medical | 2026-03-12 |
| VPAP Pediatric Face Mask (K251888) | Hsiner Co., Ltd. | 2026-03-12 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Xpert Hand (K253906) | Newclip Technics | 2026-03-11 |
| Strut Suture; No-Tie Button (K253693) | Riverpoint Medical, LLC | 2026-03-11 |
| Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) (K254047) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-03-11 |
| Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783) | Kulzer, LLC | 2026-03-11 |
| Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (K253185) | Carestream Health | 2026-03-11 |
| da Vinci Force Feedback Instruments (K253986) | Intuitive Surgical, Inc. | 2026-03-11 |
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| Picasso Pro Diode Laser (002-00460) (K254197) | CAO Group, Inc. | 2026-03-11 |
| INHANCE™ Reverse Shoulder System (K253624) | Depuy Ireland UC | 2026-03-11 |
| Varios Combi Pro2 (K260773) | Nakanishi, Inc. | 2026-03-10 |
| IPS e.max Zirconia (K253953) | Ivoclar Vivadent, Inc. | 2026-03-10 |
| Gemini NOVA 810+980 Soft Tissue Laser (K260765) | Azena Medical, LLC | 2026-03-10 |
| Straumann® BLC Implants - Indication Widening (K252168) | Institut Straumann AG | 2026-03-10 |
| Reselute Tibial Nail (K253517) | Reselute, Inc. | 2026-03-10 |
| Sonosite iLOOK Ultrasound System (K260595) | FUJIFILM Sonosite, Inc. | 2026-03-10 |
| DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (K254093) | Synthes GmbH | 2026-03-10 |
| myray ProXIma X6 (K252353) | Cefla S.C. | 2026-03-10 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (K260355) | WEBEST Biotech,, LLC | 2026-03-09 |
| FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (K251861) | Fujifilm Corporation | 2026-03-09 |
| LiverMultiScan (v6.0) (K253413) | Perspectum, Ltd. | 2026-03-09 |
| NeoSculpt Plus (K252888) | S&M Medical Co., Ltd. | 2026-03-09 |
| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189) | Zimmer, Inc. | 2026-03-09 |
| Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) (K253934) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 |
| Medicell Mycosis Laser (MCML24004) (K253960) | Medicell Healthcare Co.,LTD | 2026-03-09 |
| FiberTape Button (K260405) | Arthrex, Inc. | 2026-03-09 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032) | QIAGEN GmbH | 2026-03-09 |