| Glide (91000-GL-X) (K240884) | Infinite Biomedical Technologies, LLC | 2024-04-15 |
| Access Ostase (K232904) | Beckman Coulter | 2024-04-15 |
| Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (K223113) | Medentika GmbH | 2024-04-15 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |
| XN Knee Prosthesis System (K232175) | Beijing Chunlizhengda Medical Instruments Co., Ltd. | 2024-04-14 |
| VenusX (K232489) | Linatech, LLC | 2024-04-12 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K240686) | Healgen Scientific,, LLC | 2024-04-12 |
| Stryker Orthopaedics Hip Systems Labeling Update (K240418) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| Duo Hands-free Breast Pump (K232608) | Medela, LLC | 2024-04-12 |
| Fine Osteotomy™ (K240703) | Bodycad Laboratories, Inc. | 2024-04-12 |
| HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx (K233624) | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 |
| Disposable Extension Set (K222766) | Shandong Ande Healthcare Apparatus Co., Ltd. | 2024-04-12 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238) | Canon Medical Systems Corporation | 2024-04-12 |
| TOSAMA Reusable Applicator (K232060) | Tosama, D.O.O. | 2024-04-12 |
| Ceramic Femoral Head (K240452) | Microport Orthopedics, Inc. | 2024-04-12 |
| Access NT-proBNP (K232164) | Beckman Coulter, Inc. | 2024-04-12 |
| OASIS MRI System (K240571) | Fujifilm Healthcare Corporation | 2024-04-12 |
| Mobility+ Enteral Feeding System OTC (K233034) | Rockfield Medical | 2024-04-12 |
| UltraThineer Zirconia Slurry (5Y-B) (K240419) | Boston Micro Fabrication | 2024-04-12 |
| Disposable Injection Needles (K232200) | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 |
| Medical electronic thermometer (FC01, FC02) (K240109) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 |
| MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (K232587) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 |
| True Enhance DL (K233698) | Ge Healthcare Japan Corporation | 2024-04-11 |
| Azer Scientific Universal Transport Medium (K202531) | Azer Scientific, Inc. | 2024-04-11 |
| Lyric4 Hearing Aid (K232999) | Sonova AG | 2024-04-11 |
| TitanPico Laser Workstation (PICO-450) (K233757) | Rhein Laser Technologies Co., Ltd. | 2024-04-11 |
| Ni2 Implant System (K221847) | Newton Implant Systems, Inc. | 2024-04-11 |
| TiLink-P SI Joint Fusion System (K240720) | SurGenTec, LLC | 2024-04-11 |
| OC JuggerKnot Soft Anchor (K240719) | Riverpoint Medical | 2024-04-11 |
| uMR 680 (K240744) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 |
| CELERITY HP Indicator Tape (K240760) | Steris | 2024-04-10 |
| Keikku Electronic stethoscope (K233313) | Lapsi Health Holding B.V. | 2024-04-10 |
| 8Q10 Surclear Smoke Plume Evacuation System (K233789) | Surnic Corporation | 2024-04-10 |
| Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (K233509) | Zavation Medical Products, LLC | 2024-04-10 |
| SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (K240654) | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-04-10 |
| Electromagnetic Stimulation Systems (K232409) | Shanghai Apolo Medical Technology Co., Ltd. | 2024-04-10 |
| Neorad Pacs (Neorad Pacs) (K232641) | Everrtech Software Pvt, Ltd. | 2024-04-10 |
| 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (K233561) | Topcon Corporation | 2024-04-10 |
| Face Patches (MT-12MA, MT-12MC) (K240089) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-04-10 |
| NIRVANA (K234057) | El.En S.P.A. | 2024-04-10 |
| Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (K232523) | Mankind Pharma Limited | 2024-04-10 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599) | Genesee Biomedical, Inc. | 2024-04-09 |
| GalaFLEX LITE Scaffold (K233999) | Tepha, Inc. | 2024-04-09 |
| Universal Endometrial Applicator Set (GM11009840) (K232623) | Varian Medical Systems, Inc. | 2024-04-09 |
| Disposable Trocars (K233263) | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024-04-09 |
| CAAS Workstation (K232147) | Pie Medical Imaging BV | 2024-04-09 |
| Rho (DEN230023) | 16 Bit, Inc. | 2024-04-09 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (K240291) | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 |
| BiWaze Clear System (K231728) | Abmrc, LLC | 2024-04-08 |
| Sample preservation solution (K212878) | Zhejiang Gene Science Co., Ltd. | 2024-04-08 |
| TDM Anterior Cervical Plate System (K240423) | Tdm Co., Ltd. | 2024-04-08 |
| Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240021) | Yue Kang Anhui Medical Products Co., Ltd. | 2024-04-08 |
| APPRAISE-HRI (K233249) | The Surgeon General, Department of the Army (TSG-DA) | 2024-04-05 |
| DigiLine Direct Print Aligner System (K233935) | Park Dental Research Corporation | 2024-04-05 |
| MCG-S (AM1000) (K232823) | Amcg Co., Ltd. | 2024-04-05 |
| ELEOSx™ Limb Salvage System (DEN210058) | Onkos Surgical | 2024-04-05 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) (K233779) | MacroLux Medical Technology Co., Ltd. | 2024-04-05 |
| CorVista System with PH Add-On (K233666) | Analytics For Life, Inc. | 2024-04-05 |
| ACTIV™ Cap (K223914) | Cleansite Medical, Inc. | 2024-04-05 |
| Wireless Smart Thermometer (K233192) | Famidoc Technology Company Limited | 2024-04-05 |
| Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K232103) | Terragene S.A. | 2024-04-05 |
| Symani Surgical System (DEN230032) | Mmi North America, Inc. | 2024-04-05 |
| TDM Large Bone Plate and Screw System (K232115) | Tdm Co., Ltd. | 2024-04-05 |
| Orthobond Mariner Pedicle Screw System (DEN220015) | Orthobond Coporation | 2024-04-05 |
| ACESO Early Pregnancy Test (K234152) | Aceso Laboratories, Inc. | 2024-04-05 |
| Wrinkle Treatment Device (JM2) (K240360) | Shenzhen Qianyu Technology Co., Ltd. | 2024-04-05 |
| icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (K232792) | Icotec AG | 2024-04-05 |
| Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (K232919) | Ambu A/S | 2024-04-05 |
| Catalyst F1x Shoulder System (K234105) | Catalyst Orthoscience, Inc. | 2024-04-05 |
| G Surgical Marksman MIS System (K240737) | G Surgical, LLC | 2024-04-05 |
| Virage® Navigation System (K240647) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-04-05 |
| PINNACLETM Constrained Acetabular Liners (K240639) | Depuy Ireland UC | 2024-04-04 |
| Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (K232037) | Innovative Health, LLC | 2024-04-04 |
| Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (K233026) | Midmark Corporation | 2024-04-04 |
| ABLATE-IQ (K232227) | Neuwave Medical, Inc. | 2024-04-04 |
| KONG®-TL VBR System and KONG® C VBR System (K232790) | Icotec AG | 2024-04-04 |
| Clear Moves Aligners (K240038) | Space Maintainers Laboratories (Sml) | 2024-04-04 |
| 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) (K240652) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-04-04 |
| Preview Shoulder (K240172) | Genesis Software Innovations | 2024-04-04 |
| TRIBRID® Unicompartmental Knee System (K232114) | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| Peleton Universal Single Use Power System and Attachments (K240071) | Peleton Surgical | 2024-04-04 |
| CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (K232027) | Sebia | 2024-04-04 |
| Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (K240361) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2024-04-04 |
| ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (K233050) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 |
| VSP PEEK Cranial Implant (K231834) | 3D Systems, Inc. | 2024-04-04 |
| Agile Esophageal Stent System (K233837) | Boston Scientific Corporation | 2024-04-04 |
| Vertex Hip Fracture Nailing System (K233910) | Orthoxel Dac | 2024-04-04 |
| Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) (K240135) | Intuitive Surgical, Inc. | 2024-04-03 |
| AnyPlus II Spinal Fixation System (K240350) | GS Medical Co., Ltd. | 2024-04-03 |
| Uresta® (K233548) | Resilia, Inc. | 2024-04-03 |
| AI-Rad Companion Organs RT (K232899) | Siemens Medical Solutions U.S.A. | 2024-04-03 |
| IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) (K240282) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-04-03 |
| Oxevision Sleep Device (K233618) | Oxehealth Limited | 2024-04-03 |
| Digital Thermometer (K230889) | Wenzhou Yosun Medical Technology Co.,Ltd | 2024-04-03 |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens (K240618) | Acuity Polymers, Inc. | 2024-04-03 |
| Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (K232653) | Blue Sky Bio, LLC | 2024-04-03 |
| R&G Surgical Mask (K232112) | R&G Seguridad E Higiene Industrial S.A.C. | 2024-04-02 |
| SnapshotNIR model KD205 (K240601) | Kent Imaging, Inc. | 2024-04-02 |
| Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240080) | Syntex Healthcare Products Co., Ltd. | 2024-04-02 |