| EVOLUTION® Tibial Cones (K233507) | Microport Orthopedics, Inc. | 2024-01-18 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 (K234051) | Spinal Simplicity, LLC | 2024-01-18 |
| S-Plant Dental Implant System (K221866) | Newton Implant Systems, Inc. | 2024-01-18 |
| uEXPLORER (K231762) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K233447) | Cequr SA | 2024-01-18 |
| LuxCreo Dental Night Guard Resin (K230592) | LuxCreo, Inc. | 2024-01-18 |
| Progrip™ Self-Gripping Polypropylene Mesh (K232373) | Sofradim Production | 2024-01-18 |
| Curiteva Porous PEEK Lumbar Interbody Fusion System (K233744) | Curiteva, Inc. | 2024-01-18 |
| TriMed Threaded Intramedullary Nail System (K234040) | TriMed, Inc. | 2024-01-18 |
| TDM Screw System (K231860) | Tdm Co., Ltd. | 2024-01-18 |
| AMF TT Cones (K234011) | Lima Corporate S.P.A. | 2024-01-18 |
| Medline UNITE Ancillary Foot Recon Plating System (K234031) | Medline Industires, LP | 2024-01-18 |
| NemoScan (K232698) | Software Nemotec S.L. | 2024-01-18 |
| Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter (K233680) | William Cook Europe Aps | 2024-01-18 |
| ENFit Adaptor (K233190) | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 |
| NxStage PureFlow Solution (K233213) | Nxstage Medical, Inc. | 2024-01-18 |
| Arthrex Synergy Vision Endoscopic Imaging System (K233451) | Arthrex, Inc. | 2024-01-18 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K232860) | Pentax of America, Inc. | 2024-01-18 |
| M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle (K233031) | Canyon Medical, Inc. | 2024-01-17 |
| Radify Triage (K231871) | Envisionit Deepai, Ltd. | 2024-01-17 |
| Footprint Mini PK, 3.5mm Suture Anchor (K233730) | Smith & Nephew | 2024-01-17 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 (K232732) | Co-Innovation Biotech Co., Ltd. | 2024-01-17 |
| Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445) | Integra Lifesciences Production Corporation | 2024-01-17 |
| FlexView Diagnostic (v1.1.20) (K233226) | Radical Imaging, LLC | 2024-01-17 |
| Video Ureteroscope System (K231135) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 |
| Symphion Operative Hysteroscopy System (K233710) | Minerva Surgical, Inc. | 2024-01-17 |
| Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (K233988) | Cerenovus, Inc. | 2024-01-17 |
| Clear Guide SCENERGY (K234030) | Clear Guide Medical | 2024-01-17 |
| Delta4 Insight (K223234) | Scandidos AB | 2024-01-16 |
| Aniti-Snore Mouthguard+ (K231138) | Oscimed SA | 2024-01-16 |
| Rapid (6.0) (K233512) | Ischemaview, Inc. | 2024-01-16 |
| Uni-port (K232062) | Dalim Medical Corp. | 2024-01-16 |
| Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) (K233796) | SteriLance Medical (Suzhou), Inc. | 2024-01-16 |
| Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (K233293) | Neurosigma, Inc. | 2024-01-16 |
| Hilzo Esophageal Stents (K223266) | Thoracent, Inc. | 2024-01-16 |
| Non absorbable Surgical Silk Suture (K232355) | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 |
| Washtrays (K231144) | Dentsply Sirona | 2024-01-16 |
| Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K233970) | Nephron Nitrile, LLC | 2024-01-16 |
| CLEWICU System (K233216) | Clew Medical , Ltd. | 2024-01-13 |
| Stryker Facial iD System (K232350) | Stryker Craniomaxillofacial | 2024-01-13 |
| ClearPoint Bone Screw Fiducials (K233144) | ClearPoint Neuro, Inc. | 2024-01-12 |
| Osteoboost Belt (DEN230015) | Bone Health Technologies, Inc. | 2024-01-12 |
| Velox Power Chair (K231315) | Velox Manufacturing, Inc. | 2024-01-12 |
| A’TOMIC™ Nitinol Fixation System (K232990) | Rmr Ortho, LLC | 2024-01-12 |
| LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) (K232615) | Devicor Medical Products, Inc. | 2024-01-12 |
| PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock (K231970) | Pentax of America, Inc. | 2024-01-12 |
| Ti Link Abutment (K232170) | Izenimplant Co., Ltd. | 2024-01-12 |
| SoloSmart Injection Pen Adapter (SoloSmart®) (K231820) | Biocorp Production | 2024-01-12 |
| BEE Cervical Cage (K231371) | NGMedical GmbH | 2024-01-12 |
| Quick - Radius Disposable Set (K231684) | GM Dos Reis Industria e Comercio Ltda. | 2024-01-12 |
| SMB Luer lock disposable syringe (K231558) | Smb Corporation of India | 2024-01-12 |
| Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K233520) | Anhui Powerguard Technology Co., Ltd. | 2024-01-12 |
| GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (K233964) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 |
| Fibresolve (DEN220040) | Imvaria, Inc. | 2024-01-12 |
| ClearPointer Optical Navigation Wand (K233155) | ClearPoint Neuro, Inc. | 2024-01-12 |
| MD Mattress Suture Placement Device (K222783) | Lsi Solutions, Inc. | 2024-01-12 |
| Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small (K233022) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-12 |
| Meridian Interbody System; WaveForm A Interbody System (K233694) | SeaSpine Orthopedics Corporation | 2024-01-12 |
| TauTona Pneumoperitoneum Assist Device (TPAD) (K233020) | Tautona Group Research & Development, Co., LLC | 2024-01-12 |
| SmartFrame OR (K233141) | ClearPoint Neuro, Inc. | 2024-01-12 |
| Zirconia Block (K233125) | Hangzhou Ivista Medical Devices Co., Ltd. | 2024-01-12 |
| DermaSensor (DEN230008) | Dermasensor, Inc. | 2024-01-12 |
| Hem-o-lok® Ligating Clips (K232970) | Teleflex Medical | 2024-01-12 |
| Biograph VK10 (K233677) | Siemens Medical Solutions USA, Inc. | 2024-01-12 |
| PROBEAT-FR (K232032) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 |
| Cypris eXact Suturing System (K233355) | Cypris Medical | 2024-01-12 |
| LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) (K233114) | Shenzhen Idea Light Limited | 2024-01-12 |
| ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945) | Philips Medical Systems Dmc GmbH | 2024-01-11 |
| PRIMA Humeral System; PRIMA TT Glenoid (K233712) | Lima Corporate S.P.A. | 2024-01-11 |
| Clevaligner Software (V1.0.0) (K233616) | Clevaligner, Ltd. | 2024-01-11 |
| CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) (K231774) | MacroLux Medical Technology Co., Ltd. | 2024-01-11 |
| ToxiSeal Vial Adapter with External Balloon (K222929) | Epic Medical Pte. , Ltd. | 2024-01-11 |
| Copper Foam Dressing (Prescription and OTC) (K231088) | Roosin Medical Co., Ltd. | 2024-01-11 |
| SurgiCount+ System (K232250) | Stryker Instruments | 2024-01-11 |
| BrainSee (DEN220066) | Darmiyan, Inc. | 2024-01-11 |
| Disposable Hemoclip (AF series) (K231633) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-01-11 |
| Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe (K232995) | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-11 |
| IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) (K233664) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-01-11 |
| U-Lite PRO (K232285) | Sonoscanner Sarl | 2024-01-11 |
| Axon Therapy (K233364) | Neuralace Medical, Inc. | 2024-01-10 |
| Numen Coil Embolization System; NumenFR Detachment System (K232955) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Zeta Cranial Navigation System (ZNS131-US) (K233903) | Zeta Surgical, Inc. | 2024-01-10 |
| LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (K232604) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-10 |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (K233944) | CarboFix Orthopedics , Ltd. | 2024-01-10 |
| 1788 4K Camera System with Advanced Imaging Modality (K233327) | Stryker Endoscopy | 2024-01-09 |
| Dental Cone-beam Computed Tomography (K232710) | Yian Medical Technology (Haining) Co., Ltd. | 2024-01-09 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) (K232597) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| Electronic Muscle Stimulator (Model MP01) (K233035) | Shenzhen Hengbosi Industrial Co., Ltd. | 2024-01-08 |
| HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) (K232894) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-08 |
| DASI Dimensions (V1.0) (K231324) | Dasi Simulations | 2024-01-08 |
| LungQ v3.0.0 (K232412) | Thirona BV | 2024-01-08 |
| InkSpace Imaging Small Body Array (K233444) | Inkspace Imaging, Inc. | 2024-01-08 |
| Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 (K233615) | Baisheng Medical Co., Ltd. | 2024-01-08 |
| Air Gap Fiber (K232106) | Wontech Co., Ltd. | 2024-01-08 |
| autoSCORE (K231068) | Holberg Eeg AS | 2024-01-07 |
| Teleport XT Microcatheter (K231608) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 |
| Lifetech Cardio Temporary Pacemaker (K232721) | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024-01-07 |