| K202531 — Azer Scientific Universal Transport Medium | Azer Scientific, Inc. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240719 — OC JuggerKnot Soft Anchor | Riverpoint Medical Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233698 — True Enhance DL | Ge Healthcare Japan Corporation Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233757 — TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221847 — Ni2 Implant System | Newton Implant Systems, Inc. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232999 — Lyric4 Hearing Aid | Sonova AG Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233789 — 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234057 — NIRVANA | El.En S.P.A. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232641 — Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233313 — Keikku Electronic stethoscope | Lapsi Health Holding B.V. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240089 — Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240744 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232409 — Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240760 — CELERITY HP Indicator Tape | Steris Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230023 — Rho | 16 Bit, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232623 — Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233999 — GalaFLEX LITE Scaffold | Tepha, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233263 — Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232147 — CAAS Workstation | Pie Medical Imaging BV Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240423 — TDM Anterior Cervical Plate System | Tdm Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240021 — Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Yue Kang Anhui Medical Products Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231728 — BiWaze Clear System | Abmrc, LLC Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212878 — Sample preservation solution | Zhejiang Gene Science Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Icotec AG Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232115 — TDM Large Bone Plate and Screw System | Tdm Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233249 — APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240647 — Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210058 — ELEOSx Limb Salvage System | Onkos Surgical Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233935 — DigiLine Direct Print Aligner System | Park Dental Research Corporation Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220015 — Orthobond Mariner Pedicle Screw System | Orthobond Coporation Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240737 — G Surgical Marksman MIS System | G Surgical, LLC Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233666 — CorVista System with PH Add-On | Analytics For Life, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | MacroLux Medical Technology Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234105 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2 | Ambu A/S Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233192 — Wireless Smart Thermometer | Famidoc Technology Company Limited Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232823 — MCG-S (AM1000) | Amcg Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223914 — ACTIV Cap | Cleansite Medical, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240360 — Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234152 — ACESO Early Pregnancy Test | Aceso Laboratories, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230032 — Symani Surgical System | Mmi North America, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233837 — Agile Esophageal Stent System | Boston Scientific Corporation Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240652 — Ice Cooling 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, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |