| Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (K242370) | Medline Industries, LP | 2024-12-19 |
| Cristaline Aligners Z FLX (K242892) | Cristaline Aligners GmbH | 2024-12-19 |
| Integrity V500 (Integrity, Integrity with VEMP) (K242954) | Vivosonic, Inc. | 2024-12-19 |
| Electric Wheelchair (HC820N) (K243440) | Yongkang Hengyi Vehicle Co., Ltd. | 2024-12-19 |
| Therapy EC, Therapy XT (K232813) | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024-12-19 |
| LibAirty Airway Clearance System (K242063) | Synchrony Medical , Ltd. | 2024-12-19 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (K243169) | Thermo Fisher Scientific | 2024-12-19 |
| Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (K241322) | Joytech Healthcare Co. , Ltd. | 2024-12-19 |
| IQ-UIP (K242467) | Imbio, Inc. | 2024-12-19 |
| Saige-Density (2.5.0) (K243705) | DeepHealth, Inc. | 2024-12-19 |
| Shadow Catheter (K240885) | Simpson Interventions, Inc. | 2024-12-19 |
| Hudson RCI Comfort Flo® CubCannula™ (K241778) | Medline Industries, LP | 2024-12-19 |
| System 83 Revolve Endoscope Washer/Disinfector (K241168) | Wassenburg Medical, Inc. | 2024-12-19 |
| Quantum Mitohormesis (QMT) (M2101) (K240348) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (K243652) | Cardinalhealth | 2024-12-19 |
| Saige-Dx (3.1.0) (K243688) | DeepHealth, Inc. | 2024-12-19 |
| Active System; Avenue8 (K241395) | Caerus Corporation | 2024-12-18 |
| Bluebird Single-Use Respiratory Effort Belt (K242424) | Cadwell Industries, Inc. | 2024-12-18 |
| FirstFit Surgical Kit (K240763) | Freudenberg Medical, LLC | 2024-12-18 |
| GENTAFIX® (1, 3, 3MV) (K242216) | Teknimed Sas | 2024-12-18 |
| Lyka® PORT Needle Free Access Device (4170Y) (K241058) | Quest Medical, Inc. | 2024-12-18 |
| Respiratory Muscle Trainer (K240959) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-18 |
| Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (K242535) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 |
| EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (K243609) | Etex Corporation | 2024-12-18 |
| Physica Porous Femoral Components (K243615) | Lima Corporate S.P.A. | 2024-12-18 |
| ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (K241132) | Artsmedia Denmark Aps | 2024-12-18 |
| Falcon/Xpress (Falcon/Xpress) (K242662) | Viasonix , Ltd. | 2024-12-18 |
| Amethyst HP PTA OTW 0.035 Catheter (K241040) | Natec Medical , Ltd. | 2024-12-18 |
| Xpert MRSA/SA SSTI (K243625) | Cepheid® | 2024-12-18 |
| ARTSMedia Semen Wash Medium (K241095) | Artsmedia Denmark Aps | 2024-12-18 |
| Tens & Ems Device (TU1080) (K242787) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-12-18 |
| Klockner Kits (K243128) | SOADCO, S.L. | 2024-12-18 |
| 3Delta UNlimited (K243720) | Deltamed GmbH | 2024-12-18 |
| Porous Biologic Scaffold (K240765) | Ventris Medical | 2024-12-18 |
| Sentinel Camera (K243664) | Ai Optics | 2024-12-17 |
| Autoclave Indicator Tape; EO Indicator Tape (K241036) | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 |
| Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (K243365) | Healgen Scientific,, LLC | 2024-12-17 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
| Reform Pedicle Screw System (K242297) | Precision Spine, Inc. | 2024-12-17 |
| Quantium (K242816) | Bisco, Inc. | 2024-12-17 |
| Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K242558) | O&M Halyard, Inc. | 2024-12-17 |
| Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (K242987) | Allengers Global Healthcare Private Limited | 2024-12-17 |
| BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (K242146) | Smith & Nephew Medical Limited | 2024-12-17 |
| POCKET TENS (EP-300) (K242815) | Hivox Biotek, Inc. | 2024-12-17 |
| Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |
| Lucitone Digital Print Denture™ System (K243336) | Dentsply Sirona, Inc. | 2024-12-17 |
| Tornus ES (K241801) | Asahi Intecc Co., Ltd. | 2024-12-17 |
| Cntrl+ Bladder Support Pessary (K240798) | Cntrl+, Inc. | 2024-12-17 |
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| ALLONUS Tech Prosthetics (K241616) | Allonus Tech Co., Ltd. | 2024-12-17 |
| VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (K242413) | Vizionfocus, Inc. | 2024-12-17 |
| Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (K223093) | Inova Diagnostics, Inc. | 2024-12-17 |
| MSKai (K240793) | Mskai | 2024-12-16 |
| AIM (N/A) (K240937) | Inventeur, LLC | 2024-12-16 |
| Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839) | Yung Sheng Optical Co., Ltd. | 2024-12-16 |
| TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (K242015) | DRGEM Corporation | 2024-12-16 |
| LUOFUCON® Silver Collagen Dressing (K240809) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 |
| ACHIEVE Partial Knee System (K242307) | Ignite Orthomotion | 2024-12-16 |
| da Vinci Surgical System (IS5000) (K243641) | Intuitive Surgical, Inc. | 2024-12-16 |
| XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003) | Aesculap, Inc. | 2024-12-16 |
| Extraction Basket (K243471) | Micro-Tech (Nanjing) Co., Ltd. | 2024-12-16 |
| Dental Implants and Abutments (K243066) | Ditron Dental, Ltd. | 2024-12-16 |
| ULTIMUS Series Ultrasound Diagnostic System (K240676) | Vinno Technology (Suzhou) Co.,Ltd | 2024-12-16 |
| TEMBO Embolic System (K240873) | Instylla, Inc. | 2024-12-16 |
| Sim&Size (K242124) | Sim&Cure | 2024-12-14 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K243635) | Carlsmed, Inc. | 2024-12-13 |
| Laminar P1 (LDH-HW-001) (K242487) | Laminar Digital Health, Inc. | 2024-12-13 |
| Uro-G HD Cystoscope (1520) (K243196) | Uroviu Corporation | 2024-12-13 |
| Agilis NxT Steerable Introducer Dual-Reach (K243493) | ABBOTT MEDICAL | 2024-12-13 |
| Bioscope Neuromonitor Device (K233001) | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 |
| Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (K241998) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-12-13 |
| CAIs Sensor (CAIs-001) (K241160) | Brainu Co., Ltd. | 2024-12-13 |
| LOCK-IN Spinal Fixation System (K243281) | Lock-In USA Corp | 2024-12-13 |
| LCD Monitor (MDEC-2523) (K243307) | Barco N.V. | 2024-12-13 |
| Vivo 3 (K240779) | Breas Medical AB | 2024-12-13 |
| Remex Spine Surgery Navigation Instrument (K243560) | Remex Medical Corp. | 2024-12-13 |
| BTL-785BNF-E (K242532) | BTL Industries, Inc. | 2024-12-13 |
| Anterion (K240924) | Heidelberg Engineering GmbH | 2024-12-13 |
| Vivo 1, Vivo 2 (K240778) | Breas Medical AB | 2024-12-13 |
| ABL90 FLEX PLUS System (K240998) | Radiometer Medicals Aps | 2024-12-13 |
| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
| Gastro Concepts Air Assist (K242668) | Gastro Concepts, LLC | 2024-12-13 |
| ARIA Radiation Therapy Management System (18.1) (K242463) | Varian Medical Systems, Inc. | 2024-12-13 |
| HeartBeam AIMIGo(TM) System (K231424) | Heartbeam, Inc. | 2024-12-13 |
| Natus Ultrapro S100 (982A0594) (K243495) | Natus Neurology Incorporated | 2024-12-12 |
| Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (K242453) | Terragene S.A. | 2024-12-12 |
| NExT Station; NExT Station Advanced (K242832) | Eb Neuro S.P.A. | 2024-12-12 |
| Medicon Epiplating System (K241253) | Cmf Medicon Surgical, Inc. | 2024-12-12 |
| Aqua Medical RF Vapor Ablation System (K241271) | Aqua Medical, Inc. | 2024-12-12 |
| visio.lign color, visio.lign shield (K240735) | Bredent GmbH & Co. KG | 2024-12-12 |
| Infrascanner Model 2500 (Model 2500) (K241389) | Infrascan, Inc. | 2024-12-12 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K242020) | Philips Ultrasound, LLC | 2024-12-12 |
| Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (K243540) | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 |
| GENIOVA aligners (K233152) | Geniova Technologies Sociedad Limitada | 2024-12-12 |
| Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (K242934) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K243538) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 |
| TECHFIT DISRP® System (K242263) | Techfit Digital Surgery, Inc. | 2024-12-11 |
| VECTR – Video Endoscopic Carpal Tunnel Release System (K242417) | Rafael Medical Devices, LLC | 2024-12-11 |
| EndoTool IV (3.1) (K241088) | Monarch Medical Technologies | 2024-12-11 |
| Alinity c Benzodiazepines Reagent Kit (K243498) | Microgenics Corporation | 2024-12-11 |