| CO2 Laser Machine (Monica-I,Monica-II) (K260974) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (K253152) | Biozen, LLC | 2026-05-06 |
| Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (K252552) | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 |
| YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff (K260747) | Nihon Kohden Corporation | 2026-05-06 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |
| Anchor with Fiber Wire and Disposable Inserter (K253027) | Ortobio S.A. | 2026-05-06 |
| CastleLoc-P Anterior Cervical Plate System (K261112) | L&K BIOMED Co., Ltd. | 2026-05-06 |
| KardiaPSI Balloon Catheter (K253855) | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
| Denture Base (K260376) | Shandong Huge Dental Material Corporation | 2026-05-06 |
| Healium Intelliscan LX192LC (K261132) | Healium Intelliscan Corporation | 2026-05-05 |
| Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) (K254200) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2026-05-05 |
| MectaLIF 3D Metal Anterior (K254202) | Medacta International S.A. | 2026-05-05 |
| Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) (K260742) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-05 |
| AccelFix Spinal Fixation System (K261130) | L&K BIOMED Co., Ltd. | 2026-05-05 |
| Lumify Diagnostic Ultrasound System (K252558) | Philips Ultrasound, LLC | 2026-05-05 |
| Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (K253251) | Leaseir Technologies, Slu | 2026-05-04 |
| Wound Geni NPWT System (K254019) | Bechtel Medical, Inc. | 2026-05-04 |
| MammoSightAI (K252954) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 |
| Neowise (K260716) | Cefla S.C. | 2026-05-04 |
| Q-Switched Nd: YAG Laser Systems (K260256) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) (K252543) | Amsino International, Inc. | 2026-05-04 |
| ArteraAI Breast (K254115) | Artera, Inc. | 2026-05-04 |
| Male Latex Condom HA (K252622) | Okamoto USA, Inc. | 2026-05-04 |
| Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (K260688) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-05-04 |
| Phototherapy System (DUV-COMBO) (K254234) | Choyang Medics Co., Ltd. | 2026-05-01 |
| Zeta Navigation System (K253663) | Zeta Surgical, Inc. | 2026-05-01 |
| BioCode® Respiratory Pathogen Panel (RPP) (K254139) | Applied BioCode, Inc. | 2026-05-01 |
| ABL90 FLEX PLUS System (K252488) | Radiometer Medicals Aps | 2026-05-01 |
| ABL90 FLEX PLUS System (K252475) | Radiometer Medicals Aps | 2026-05-01 |
| ArthroTAK Tendon Anchor Kit (K252635) | ArthroTAK, LLC | 2026-05-01 |
| FX V135 EASYTECH® Shoulder System (K254154) | FX Shoulder Solutions, Inc. | 2026-05-01 |
| Capnostream™35 Portable Respiratory Monitor (PM35MN) (K253030) | Covidien, LLC | 2026-05-01 |
| Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) (K253887) | Philips Medizin Systeme | 2026-05-01 |
| VOCO Profluorid Varnish + BioMin (K252073) | Voco GmbH | 2026-05-01 |
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| OSSIOfiber® Threaded Trimmable Fixation Nail (K254077) | OSSIO , Ltd. | 2026-05-01 |
| Verifine Safety Lancets (K261045) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| Prolystica Pass Thru Disinfectant Wipes (DEN240075) | Steris | 2026-05-01 |
| Oxiplex (K253326) | Fziomed, Inc. | 2026-05-01 |
| Tutamen Self Adhesive Electrodes (K252439) | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 |
| Any-Com Seal (K260819) | Mediclus Co., Ltd. | 2026-05-01 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K253966) | Spineart SA | 2026-05-01 |
| EndoTool IV Cloud 1.0 (K260910) | Glooko, Inc. | 2026-05-01 |
| Ancora-SB (K260314) | Aspero Medical, Inc. | 2026-05-01 |
| Ambu® Virobac II® Exhalation Filter (K251583) | Ambu A/S | 2026-04-30 |
| AllTest Strep A Rapid Test (K260342) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 |
| Bayesian Health Sepsis Flagging Device (K250680) | Bayesian Health, Inc. | 2026-04-30 |
| BEE PLIF Cage (K261067) | NGMedical GmbH | 2026-04-30 |
| AffloVest® Mobile Airway Clearance Therapy (K252849) | Tactile Medical | 2026-04-30 |
| OrthoPediatrics® Locking Cannulated Blade Plate System (K260323) | OrthoPediatrics Corp. | 2026-04-30 |
| BloodSTOP iX Trauma Matrix (TM-iX-20) (K253017) | Lifescience Plus, Inc. | 2026-04-30 |
| Synapse 3D Base Tools (V7.2) (K254189) | Fujifilm Corporation | 2026-04-30 |
| iLet ACE Pump (K253976) | Beta Bionics, Inc. | 2026-04-30 |
| FSYX Ocular Pressure Adjusting Pump (K252455) | Balance Ophthalmics, Inc. | 2026-04-30 |
| Aurie System (DEN250023) | Cathbuddy, Inc. | 2026-04-30 |
| Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) (K253064) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-04-30 |
| 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) (K252858) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| Intelligent NR (K252503) | Canon, Inc. | 2026-04-30 |
| c-med0 alpha (K253436) | Cosinuss GmbH | 2026-04-30 |
| UltraEZ (K261404) | Ultradent Products, Inc. | 2026-04-30 |
| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| SCRIPT™ Implant System (K253401) | Globus Medical, Inc. | 2026-04-29 |
| ES-Series (K260589) | E-Scopics | 2026-04-29 |
| Paptizer 360 (K252471) | LiViliti Health Products Corporation | 2026-04-29 |
| Break Wave (K261086) | Sonomotion, Inc. | 2026-04-29 |
| YellowStar (K261094) | Asclepion Laser Technologies GmbH | 2026-04-29 |
| PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES (K253885) | GEO MEDICAL CO., LTD. | 2026-04-29 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| LEO Spinal System (K252542) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| Echo Large Bore Introducer Sheath (K260606) | Echo Medical, LLC | 2026-04-29 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire (K253579) | Scientia Vascular, Inc. | 2026-04-29 |
| Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) (K253914) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 |
| DeepHealth ProstateAI (K253682) | Quantib B.V. | 2026-04-29 |
| Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) (K252831) | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 2026-04-28 |
| Ultra-Fast Warm (K260248) | Kitazato Corporation | 2026-04-28 |
| SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (K260065) | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 |
| Vacuum Pump (Model: AD-VPUM-500) (K260194) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 |
| M.U.S.T. Pedicle Screw System - Extension (K253940) | Medacta International S.A. | 2026-04-28 |
| Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) (K260260) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| SAM 3.0 Multi-Hour Continuous Ultrasound Device (K260076) | ZetrOZ Systems, LLC | 2026-04-28 |
| Cardinal Health™ Poly Reinforced Surgical Gown (K253243) | Cardinal Health 200, LLC | 2026-04-28 |
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| Manual Wheelchair (7101L, 7102LHD) (K260121) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 |
| Surgical Microscope (OMS2360, OMS2380) (K252464) | Zumax Medical Co., Ltd. | 2026-04-28 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) (K252501) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| Pelvic Floor Exerciser (PF01) (K252748) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 |
| Avenir® Müller Stem; Avenir Complete™ Hip System (K260182) | Zimmer, Inc. | 2026-04-27 |
| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| TearCare MGX System (K252409) | Sight Sciences, Inc. | 2026-04-27 |
| Grandio disc multicolor (K261357) | Voco GmbH | 2026-04-27 |
| Dura-Crown (K261356) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| SABER-C System (K260660) | Elevation Spine | 2026-04-27 |
| CASSIE (K252628) | Wesper, Inc. | 2026-04-27 |
| STA Satellite Max® (K253658) | Diagnostica Stago, Inc. | 2026-04-27 |
| NovoKnee (SteriKnee) (K261032) | NovoSource | 2026-04-27 |
| Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (K253580) | Tedan Surgical Innovations | 2026-04-26 |
| Vista CMS (K250349) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 |
| LoFric Elle Pro (K260999) | Wellspect AB | 2026-04-24 |
| PC Fix System (K260411) | Chest Wall Innovations, Inc. | 2026-04-24 |
| ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (K260549) | Zsfab, Inc. | 2026-04-24 |