| Surgical Gown (K222999) | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 |
| F&P 950 Respiratory Humidifier (K220703) | Fisher & Paykel Healthcare | 2023-06-16 |
| IB Lab LAMA (K223646) | Ib Lab GmbH | 2023-06-16 |
| The iNAP One Sleep Therapy System (K220907) | Somnics, Inc. | 2023-06-16 |
| EyeArt v2.2.0 (K223357) | Eyenuk, Inc. | 2023-06-16 |
| DeepCatch (K223556) | Medical IP Co., Ltd. | 2023-06-16 |
| SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash (K230421) | Siemens Medical Solutions USA, Inc. | 2023-06-16 |
| All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid (K230538) | Sonova AG | 2023-06-16 |
| Neoasis (DEN220048) | Invictus Medical, Inc. | 2023-06-16 |
| Fitness Belt (Model: KLT-07) (K231136) | Shenzhen Kelutongda Industrial Co., Ltd. | 2023-06-16 |
| Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 (K222906) | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-16 |
| BabySat 3 (K222597) | Owlet Babycare, Inc. | 2023-06-16 |
| OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (K230015) | Laurane Medical Sas | 2023-06-16 |
| Smart Correction System (HA Half Pins) (K231461) | Wishbone Medical, Inc. | 2023-06-16 |
| NuVasive Modulus ALIF System (K230894) | Nu Vasive, Incorporated | 2023-06-16 |
| Manual Wheelchair (A006) (K231110) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2023-06-16 |
| Mindray SV600 Ventilator, Mindray SV800 Ventilator (K220107) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 |
| Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (K230514) | NIKKISO CO., LTD. | 2023-06-16 |
| NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens (K230910) | Acculens, Inc. | 2023-06-16 |
| Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (K230965) | Acuity Polymers, Inc. | 2023-06-16 |
| WallFlex™ Biliary RX Stent System (K223469) | Boston Scientific Corporation | 2023-06-15 |
| Xerxes Hip Stem (K231109) | Xerxes Arthopedix, LLC | 2023-06-15 |
| IPL Hair Removal Device Models: MLY-T069 (K230473) | Miley Technology (Hebei) Co., Ltd. | 2023-06-15 |
| Zevo Anterior Cervical Plate System (K231090) | Medtronic Sofamor Danek USA, Inc. | 2023-06-15 |
| Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (K223717) | STERIS Corporation | 2023-06-15 |
| EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 (K222861) | Olympus Medical Systems Corporation | 2023-06-15 |
| SpassageQ (K230386) | Spass, Inc. | 2023-06-15 |
| TNI Clear-Guard™ 3 angled breathing filter (1545020) (K223258) | Intersurgical , Ltd. | 2023-06-15 |
| Celerity Incubator (K223715) | STERIS Corporation | 2023-06-15 |
| EDEN Spinal Fixation MIS System (K230762) | Jmt Co., Ltd. | 2023-06-15 |
| UTC 3mL Medication Cartridge (K230718) | Gilero, LLC | 2023-06-15 |
| ERBEJET® 2 System (K231023) | Erbe Elektromedizin GmbH | 2023-06-15 |
| TRIGEN META-NAIL Nail System (K230761) | Smith & Nephew, Inc. | 2023-06-14 |
| Electronic Blood Pressure Monitor (K223291) | Shenzhen Pango Medical Electronics Co., Ltd. | 2023-06-14 |
| Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (K230536) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 |
| ClearumTM HS (K231406) | Bellco Srl | 2023-06-14 |
| Synexis Sphere Rx (K221540) | Synexis, LLC | 2023-06-14 |
| F65 Laser System (K222790) | Lumenis Be, Ltd. | 2023-06-14 |
| VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (K222822) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| Zavation ALIF System (K230731) | Zavation Medical Products, LLC | 2023-06-14 |
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| IR SLA Type Implant System (K222144) | Biotem Co., Ltd. | 2023-06-14 |
| 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) (K230573) | Kossan International Sdn Bhd | 2023-06-13 |
| Tisuthes e-PTFE Surgical Patch (K201153) | Shanghai Suokang Medical Implants Co., Ltd. | 2023-06-13 |
| Axis Anterior Cervical Plate System (K231145) | Southern Medical (Pty) , Ltd. | 2023-06-13 |
| SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) (K230759) | Bosungmeditech Co., Ltd. | 2023-06-13 |
| iOrtho (K223518) | Shanghai EA Medical Instruments Co., Ltd. | 2023-06-13 |
| CAC Software (K230112) | Imbio, Inc. | 2023-06-13 |
| Clear Aligner (K223517) | Wuxi EA Medical Instruments Technologies Limited. | 2023-06-13 |
| OptiVu™ ROSA® MxR (K230567) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 |
| SecurePortIV Advanced Catheter Securement Adhesive (K223669) | Adhezion Biomedical, LLC | 2023-06-12 |
| Cut Screw - Percutaneous Compression Screw (K230397) | GM Dos Reis Industria e Comercio Ltda. | 2023-06-12 |
| SpiroHome Personal, SpiroHome Clinic (K213754) | Inofab Saglik Teknolojileri A.S | 2023-06-12 |
| Atellica® CH Diazo Direct Bilirubin (D_DBil) (K223078) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 |
| Pounce™ Thrombectomy System (K231022) | Surmodics,Inc. | 2023-06-12 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| Genadyne Hybrid Foam Dressings (K221888) | Genadyne Biotechnologies, Inc. | 2023-06-12 |
| BMR 1900 PHISIO (K223361) | Sorin Group Italia S.R.L. | 2023-06-10 |
| BruxZir™ TintEFX Coloring Liquid (K231347) | Prismatik Dentalcraft, Inc. | 2023-06-09 |
| DJF Intravascular Administration Set (K230992) | Yangzhou Wei DE LI Trade Co., Ltd. | 2023-06-09 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (K223865) | Edwards Lifesciences, LLC | 2023-06-09 |
| JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor (K230728) | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-09 |
| Acumed Acutrak 3 Headless Compression Screw System (K230744) | Acumed, LLC | 2023-06-09 |
| M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (K230768) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-09 |
| Eroxon (DEN220078) | Futura Medical Developments Limited | 2023-06-09 |
| CT Perfusion V1.0 (K223091) | Olea Medical | 2023-06-09 |
| OrthoPulse 2.0E (OPi2E-100) (K230905) | Biolux Technology GmbH | 2023-06-09 |
| LVIS NeuroMatch (K222450) | LVIS Corporation | 2023-06-09 |
| Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K230779) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-06-09 |
| Fixone Biocomposite Anchor (K230892) | Aju Pharm Co., Ltd. | 2023-06-09 |
| Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) (K230776) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-06-09 |
| Orthopantomograph™ OP 3D LX (K230505) | Palodex Group OY | 2023-06-09 |
| RODIN™ Expandable Lumbar Cage System (K231359) | Ctl Medical Corporation | 2023-06-09 |
| NovoGen Wound Matrix (K220498) | Novabone Products, LLC | 2023-06-09 |
| Ear Pressure Relief Device(Model:ER813B) (K230502) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| Gamma4 System (K230512) | Stryker GmbH | 2023-06-09 |
| MyKnee UNI-ST (K231037) | Medacta International S.A. | 2023-06-09 |
| Renuvion® Micro Handpiece (K230586) | Apyx Medical Corporation | 2023-06-09 |
| Auryon Atherectomy System (K230709) | Eximo Medical, Ltd. | 2023-06-09 |
| TheraFace Mask (K230293) | Therabody, Inc. | 2023-06-09 |
| Bemer Therapy System Evo (K231368) | Bemer Int AG | 2023-06-09 |
| AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (K223918) | Philips Medical Systems Nederland B.V. | 2023-06-08 |
| Acumen Hypotension Prediction Index (HPI) Algorithm (K230057) | Edwards Lifesciences, LLC | 2023-06-08 |
| Promisemed Safety Huber Needle (K230715) | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 |
| Zionic Aesthetic (K230659) | Termosalud | 2023-06-08 |
| SNUCONE Tissue Level Implant System (K222792) | Snucone Co., Ltd. | 2023-06-08 |
| OCD MT Cap (85-00397-000) (K231350) | Neuronetics | 2023-06-08 |
| Disposable Laparoscopic Trocar (K231042) | Changzhou Ankang Medical Instruments Co., Ltd. | 2023-06-08 |
| Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe (K222001) | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 |
| Ablamap® System (K230008) | Ablacon, Inc. | 2023-06-08 |
| SIDDHARTH-II;IMPACT (K222762) | Panacea Medical Technologies Pvt. , Ltd. | 2023-06-08 |
| XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (K222684) | Stryker Spine | 2023-06-08 |
| AlloX2 Pro Tissue Expanders (K214124) | Sientra, Inc. | 2023-06-08 |
| BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) (K230651) | Becton, Dickinson and Company | 2023-06-07 |
| Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) (K231002) | Suzhou Endophix Co., Ltd. | 2023-06-07 |
| Fenom Pro (K213611) | Caire Diagnostics, Inc. | 2023-06-07 |
| Infrared Thermometer (K222248) | Alicn Medical Shenzhen, Inc. | 2023-06-07 |
| Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381) | Cs Medical, LLC | 2023-06-07 |
| Ambra PACS (K231360) | Dicom Grid Dba Ambra Health | 2023-06-07 |
| C350/C350G LCD Monitor; M550/M550G LCD Monitor (K231170) | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-07 |