| K222906 — Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd. Jun 16, 2023 |
| K222597 — BabySat 3 | Owlet Babycare, Inc. Jun 16, 2023 |
| K231045 — Healgen URS Test Strips | Healgen Scientific,, LLC Jun 16, 2023 |
| K223646 — IB Lab LAMA | Ib Lab GmbH Jun 16, 2023 |
| K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc. Jun 16, 2023 |
| K230538 — All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG Jun 16, 2023 |
| K220907 — The iNAP One Sleep Therapy System | Somnics, Inc. Jun 16, 2023 |
| K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. Jun 16, 2023 |
| K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. Jun 16, 2023 |
| K230015 — OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | Laurane Medical Sas Jun 16, 2023 |
| K230894 — NuVasive Modulus ALIF System | Nu Vasive, Incorporated Jun 16, 2023 |
| K223890 — NAJA Gastrointestinal Catheter | Chess Medical, Inc. Jun 16, 2023 |
| K230965 — Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. Jun 16, 2023 |
| K222999 — Surgical Gown | Hubei Woozon Healthcare Co., Ltd. Jun 16, 2023 |
| K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 16, 2023 |
| K231461 — Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. Jun 16, 2023 |
| K221121 — Volumat Polyethylene I.V. Administration Set | Fresenius Kabi Jun 16, 2023 |
| K231199 — Solar Lumbar Interbody Fusion System | Degen Medical Jun 16, 2023 |
| K231110 — Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd Jun 16, 2023 |
| K220703 — F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare Jun 16, 2023 |
| K231109 — Xerxes Hip Stem | Xerxes Arthopedix, LLC Jun 15, 2023 |
| K231090 — Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. Jun 15, 2023 |
| K223469 — WallFlex Biliary RX Stent System | Boston Scientific Corporation Jun 15, 2023 |
| K230718 — UTC 3mL Medication Cartridge | Gilero, LLC Jun 15, 2023 |
| K230386 — SpassageQ | Spass, Inc. Jun 15, 2023 |
| K230762 — EDEN Spinal Fixation MIS System | Jmt Co., Ltd. Jun 15, 2023 |
| K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation Jun 15, 2023 |
| K222861 — EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation Jun 15, 2023 |
| K230473 — IPL Hair Removal Device Models: MLY-T069 | Miley Technology (Hebei) Co., Ltd. Jun 15, 2023 |
| K223258 — TNI Clear-Guard 3 angled breathing filter (1545020) | Intersurgical , Ltd. Jun 15, 2023 |
| K231023 — ERBEJET® 2 System | Erbe Elektromedizin GmbH Jun 15, 2023 |
| K223715 — Celerity Incubator | STERIS Corporation Jun 15, 2023 |
| K222790 — F65 Laser System | Lumenis Be, Ltd. Jun 14, 2023 |
| K231406 — ClearumTM HS | Bellco Srl Jun 14, 2023 |
| K230731 — Zavation ALIF System | Zavation Medical Products, LLC Jun 14, 2023 |
| K222144 — IR SLA Type Implant System | Biotem Co., Ltd. Jun 14, 2023 |
| K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. Jun 14, 2023 |
| K223291 — Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. Jun 14, 2023 |
| K230761 — TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. Jun 14, 2023 |
| K221540 — Synexis Sphere Rx | Synexis, LLC Jun 14, 2023 |
| K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa Jun 14, 2023 |
| K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. Jun 14, 2023 |
| K231145 — Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. Jun 13, 2023 |
| K230567 — OptiVu ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) Jun 13, 2023 |
| K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd Jun 13, 2023 |
| K223517 — Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. Jun 13, 2023 |
| K223518 — iOrtho | Shanghai EA Medical Instruments Co., Ltd. Jun 13, 2023 |
| K201153 — Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. Jun 13, 2023 |
| K230112 — CAC Software | Imbio, Inc. Jun 13, 2023 |
| K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. Jun 13, 2023 |