| AMSCO 700 Steam Sterilizer (K261055) | STERIS Corporation | 2026-06-24 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (K252117) | Sw Technologies, Inc. | 2026-06-24 |
| ConvaVAC™ Negative Pressure Wound Therapy System (K253263) | Convatec Limited, Gdc Building | 2026-06-24 |
| Ceribell Neurology Review Software (K260998) | Ceribell, Inc. | 2026-06-24 |
| HD Camera Head OLYMPUS CH-S200-08-LB (K261260) | Olympus Medical Systems Corporation | 2026-06-24 |
| Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (K260394) | Hangzhou Jimushi Meditech Co., Ltd. | 2026-06-24 |
| SilverCeuticals® Antimicrobial Wound Gel (K251929) | Silverceuticals, Inc. | 2026-06-24 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Endoform Dermal Template (K260669) | Aroa Biosurgery , Ltd. | 2026-06-24 |
| Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (K261004) | Integra Lifesciences Production Corporation | 2026-06-23 |
| CURASYS 2 (EMDN0003) (K253199) | CG Bio Co., Ltd. | 2026-06-23 |
| Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (K253180) | Microlife Corporation | 2026-06-23 |
| AQUABEAM Robotic System (K253211) | Procept Biorobotics | 2026-06-23 |
| Urocross Expander System (UES-2018-C1) (K261342) | Prodeon Medical, Inc. | 2026-06-22 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| Flow Water-Based Personal Lubricant (K254011) | LBDO Group, Inc. | 2026-06-22 |
| Health Line Tearaway Introducer (K261950) | Health Line International Corporation | 2026-06-22 |
| RX-1 Sleep (K253148) | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 |
| Medline Reusable Blood Pressure Cuff (K254287) | Medline Industries, LP | 2026-06-22 |
| TearView (K253176) | Beyond 700 Pty, Ltd. | 2026-06-22 |
| Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) (K261076) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| DeltaNEC Interbody System (K261279) | Nexus Spine | 2026-06-22 |
| Manual Wheelchair (MS01);Manual Wheelchair (MA01) (K261075) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| CMN Capillary Function with Oncology Virtual Expert (K260316) | Cercare Medical A/S | 2026-06-22 |
| Dynamis Robotic Surgical System (K260369) | LEM Surgical AG | 2026-06-20 |
| Powder Free Nitrile Examination Gloves Non-Sterile Black (K253824) | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (K253110) | Sol-Millennium Medical, Inc. | 2026-06-18 |
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
| ZywieZ3 Sensor & Adhesive (K252839) | Zywie, Inc. | 2026-06-18 |
| Syncron-E (DEN250025) | Autonomous Healthcare, Inc. | 2026-06-18 |
| SteriBest® Sterilization Tray System (K253187) | Mastel Surgical | 2026-06-18 |
| SmartSpectra Vital Signs Monitor 1.0 (K254169) | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026-06-18 |
| Blood Volume Analyzer (200) (K261099) | Daxor Corporation | 2026-06-18 |
| LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (K260946) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 |
| Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) (K261701) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 |
| CORUS™ Navigation System-GN (K261665) | Providence Medical Technology, Inc. | 2026-06-18 |
| CONDUIT™ ZERO-P™ VA Secured Spacer System (K252982) | Avalign Technologies, Inc. | 2026-06-18 |
| Power Wheelchair (W5915B, W5915C, W5915D) (K253812) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| ARTHUR (K260190) | ROPCA ApS | 2026-06-18 |
| Curing Light (M-Cure 6) (K253131) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 |
| InstaTRU Instant Biological Indicator for Steam (IBI-05) (K251559) | True Indicating, LLC | 2026-06-18 |
| inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20) (K252066) | Vincent Healthcare Products Limited | 2026-06-18 |
| 3D MAC Titanium Cranial Plate (TCP) System (K253116) | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 |
| RadOncAI (K253050) | Informai | 2026-06-18 |
| MegaGen Zygoma Dental Implant System (K251232) | Megagen Implant Co., Ltd. | 2026-06-18 |
| Portable DR Imaging System (K253058) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 |
| ECMT-100 WMD (K253521) | Ecm Therapeutics, Inc. | 2026-06-18 |
| Pelvic Muscle Trainer (KM510, KM516B) (K260178) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg (K260280) | Hycor Biomedical | 2026-06-18 |
| VIVIX-S 4386W (FXRD-4386WA) (K260820) | Vieworks Co., Ltd. | 2026-06-18 |
| Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (K260636) | Stryker Sustainability Solutions | 2026-06-18 |
| Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (K254254) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 |
| Wrist Blood Pressure Monitor (XW-05) (K253126) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) | GuideAI Health | 2026-06-18 |
| Implantmed Plus II & Piezomed Plus II Module (K253776) | W&H Dentalwerk Buermoos GmbH | 2026-06-18 |
| Synapse PACS (7.6.0) (K261713) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 |
| SRGC-06 (K261246) | GC America, Inc. | 2026-06-18 |
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| Dental Implant System (K250806) | A.B. Dental Devices , Ltd. | 2026-06-18 |
| Precice™ Max System and Precice™ Ankle Salvage System (K261651) | NuVasive Specialized Orthopedics | 2026-06-18 |
| AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| PICOSURE WORKSTATION (K261570) | Cynosure, LLC | 2026-06-17 |
| INOSS System (K260006) | Inosys, Inc. | 2026-06-17 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) (K260867) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| Hydro Irrigation System (K261544) | Stryker Instruments | 2026-06-17 |
| Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (K260538) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 |
| Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (K253055) | Nordic Kinetics AB | 2026-06-17 |
| FLEXI-PORT™ Power Injectable Implantable Port (K260916) | Portal Access, Inc. | 2026-06-17 |
| twiist Automated Insulin Delivery (AID) System (K261672) | Deka Research and Development | 2026-06-17 |
| “Socko” Vimax Spinal Fixation System (K253045) | Socko Medical Co., Ltd. | 2026-06-17 |
| Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (K253255) | Foshan Pingchuang Medical Technology Co., Ltd. | 2026-06-17 |
| Fule Metallic Lockable Intramedullary Nail Systems (K253155) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| Portable Oxygen Concentrator (K252399) | Honsun (Nantong) Co., Ltd. | 2026-06-17 |
| Assisted Reproduction Laser System (Model ILS-400M) (K253333) | Hua Yue Medical Technology Co., Ltd. | 2026-06-17 |
| KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (K253001) | Hunan Ruijiong Biotech Co., Ltd. | 2026-06-16 |
| Prophecy Incompass Surgical Planning System (K253159) | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 |
| FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T (K253137) | Fujifilm Corporation | 2026-06-16 |
| Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (K260899) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-16 |
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
| Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) (K253231) | Hubei Yjt Technology Co.,Ltd | 2026-06-16 |
| LimiFlex® Dynamic Sagittal Tether Instrument Set (K253374) | Empirical Spine | 2026-06-16 |
| HERA Interlocking Intramedullary Nailing System (K253046) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| NEUROMARK System (NMK00301) (K261833) | Neurent Medical , Ltd. | 2026-06-16 |
| I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (K260958) | I.T.S. GmbH | 2026-06-16 |
| TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (K260425) | Hivox Biotek, Inc. | 2026-06-16 |
| VicorderCS (VCS-SYS-1100) (K260693) | 80 Beats Medical GmbH | 2026-06-16 |
| Lipoprotein (a) Molarity Assay (K253069) | Diazyme Laboratories, Inc. | 2026-06-16 |
| BOSS (K253723) | Medpark Co., Ltd. | 2026-06-16 |
| myAblation Guide (VC10A) (K253264) | Siemens Healthcare GmbH | 2026-06-16 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (K254025) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 |
| Augment Off-Axis Instrument System (K261683) | Zimmer, Inc. | 2026-06-16 |
| LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (K260333) | Diasorin Molecular, LLC | 2026-06-15 |
| Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (K253059) | Tournicare Pty, Ltd. | 2026-06-15 |
| Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) (K260452) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| Fule Interbody Fusion Cage System (K253151) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 |