| AETOS Shoulder System (K230572) | Smith & Nephew, Inc. | 2023-06-07 |
| HyperVue™ Imaging System (K230691) | Spectrawave, Inc. | 2023-06-07 |
| Intimate Rose Vaginal Dilators (K231430) | Plus EV Holdings Dba Intimate Rose | 2023-06-07 |
| Fix2Lock(PEEK Self Punching) (K231322) | Osteonic Co., Ltd. | 2023-06-07 |
| Xenco Medical InterAlign Cervical Interbody System (K223059) | Xenco Medical, LLC | 2023-06-07 |
| TiLink-L SI Joint Fusion System (K230446) | SurGenTec, LLC | 2023-06-07 |
| STA R Max 3, STA Compact Max 3 (K212183) | Diagnostica Stago S.A.S | 2023-06-07 |
| Pantheris LV Atherectomy Catheter (K230005) | Avinger, Inc. | 2023-06-06 |
| Gnesis EMS Plus (K230261) | Creative Fitness Developments S.L. | 2023-06-06 |
| AviClear Laser System (K230660) | Cutera, Inc. | 2023-06-06 |
| Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584) | Vein 360, LLC | 2023-06-06 |
| Diode laser therapy device (K212733) | Beijing Star New Tech Co., Ltd. | 2023-06-06 |
| Diode laser therapy device (K212734) | Triangel Rsd Limited | 2023-06-06 |
| ARC Intensive Care Information System (ARC System) (K220117) | Ordinatrum Solutions | 2023-06-06 |
| FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) | Feops NV | 2023-06-06 |
| A-Line Advanced (K231635) | Biocetec Co., Ltd. | 2023-06-06 |
| Olea S.I.A. Neurovascular V1.0 (K223532) | Olea Medical | 2023-06-06 |
| F3D Interbody System (K230329) | Corelink, LLC | 2023-06-06 |
| Cue COVID-19 Molecular Test (DEN220028) | Cue Health, Inc. | 2023-06-06 |
| Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349) | Nephron Nitrile, LLC | 2023-06-06 |
| APOLLO ADVANTAGE Nitrile Examination Gloves (K230633) | Dell Corning Corporation | 2023-06-05 |
| DynaFlex Clear Brackets & Buttons (K230225) | Dyna Flex | 2023-06-05 |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937) | Abbott Laboratories | 2023-06-05 |
| Fluido Compact Blood and Fluid Warming System (K211618) | The Surgical Company International B.V. | 2023-06-05 |
| HandX™ Self-Righting Needle Holder (K223718) | Human Xtensions , Ltd. | 2023-06-05 |
| ArtiSential Laparoscopic Instruments-Electrodes (K230498) | Livsmed, Inc. | 2023-06-05 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348) | Roche Diagnostics | 2023-06-05 |
| FX V135(TM) Shoulder Prosthesis (K223801) | Fx Shoulder USA, Inc. | 2023-06-05 |
| Zhenjiang Assure Mechanical Wheelchair,model:K1 (K231320) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 |
| Stella (K221752) | Shinhung Mst Co., Ltd. | 2023-06-04 |
| i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727) | I3 Membrane GmbH | 2023-06-02 |
| SCAR 3 (K231309) | El.En Electroinc Engineering Spa | 2023-06-02 |
| Anatomic PEEK™ Cervical Fusion System with Nanotechnology (K230936) | Nanovis, LLC | 2023-06-02 |
| Fine Osteotomy™ (K231314) | Bodycad Laboratories, Inc. | 2023-06-02 |
| CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311) | ABBOTT MEDICAL | 2023-06-02 |
| Volumat Line (K220301) | Fresenius Kabi | 2023-06-02 |
| vWF Ag (K220728) | Siemens Healthcare Diagnostics Products GmbH | 2023-06-02 |
| Pen Needle (K230635) | Jiangsu Caina Medical Co.,Ltd | 2023-06-02 |
| CorNeat EverPatch (K223074) | Corneat Vision , Ltd. | 2023-06-02 |
| Titanium Turbine (K230888) | Nakanishi, Inc. | 2023-06-02 |
| Tristel Duo ULT (DEN220041) | Tristel Solutions Limited | 2023-06-02 |
| Xpan Universal Trocar System (K223562) | Xpan, Inc. | 2023-06-02 |
| Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (K230952) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-06-02 |
| ADVIA Centaur® Anti-Müllerian Hormone (AMH) (K221801) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 |
| Huma RPM (RPM) (K230214) | Medopad, Inc. | 2023-06-02 |
| ACTIVBRAID™ (K223822) | Embody, Inc. | 2023-06-02 |
| APTUS® 3.5 TriLock Straight Plates (K230971) | Medartis AG | 2023-06-02 |
| RGS; RGS Mini (K222702) | Genesis Air, Inc. | 2023-06-02 |
| Breathe+ (K222018) | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 |
| Harvest Conceal ZR Block Out (K222961) | Harvest Dental Products, LLC | 2023-06-02 |
| Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) (K222905) | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-01 |
| Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) (K223929) | Innova Vascular, Inc. | 2023-06-01 |
| Radius VSM and Accessories (K223498) | Masimo Corporation | 2023-06-01 |
| FiberTak® Suture Anchor (K231330) | Arthrex, Inc. | 2023-06-01 |
| Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299) | Ambu A/S | 2023-06-01 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306) | Roche Molecular Systems, Inc. | 2023-06-01 |
| HardyDisk AST Rezafungin 5µg (RZF5) (K230827) | Hardy Diagnostics | 2023-06-01 |
| OmniTom Elite (K223447) | Neurologica Corporation, A Subsidiary of Samsung | 2023-06-01 |
| K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (K230408) | Sb-Kawasumi Laboratories, Inc. | 2023-06-01 |
| Drakon™ and Sequre® Microcatheters (K231293) | Accurate Medical Therapeutics | 2023-06-01 |
| Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (K230990) | Candela Corporation | 2023-06-01 |
| Surgical Face Mask (L 175*95mm) (K230617) | Henan Chaoya Medical Equipment Co., Ltd. | 2023-06-01 |
| Brainomix 360 e-CTP (K223555) | Brainomix Limited | 2023-06-01 |
| ANT-X System (K230185) | Ndr Medical Technology Pte. , Ltd. | 2023-06-01 |
| SomniCheck (K223676) | Brainmatterz, LLC | 2023-06-01 |
| Pitch PaSoft Tissue Reinforcement Device (K230671) | Xiros, Ltd. | 2023-05-31 |
| iRoot SP Plus (K231259) | Innovative Bioceramix, Inc. | 2023-05-31 |
| BTL-785X (K222556) | BTL Industries, Inc. | 2023-05-31 |
| Disposable Nitrile Gloves (ABC-DG01) (K230542) | Huizhou Anboson Technology Co., Ltd. | 2023-05-31 |
| CombiSet Hemodialysis Blood Tubing Set (K213992) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 |
| Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (K231326) | Osteonic Co., Ltd. | 2023-05-31 |
| Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K222885) | Pegavision Corporation | 2023-05-31 |
| FEELject LDV (Low dead volume) syringe (K213010) | Feeltech Co., Ltd. | 2023-05-31 |
| Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter (K221067) | Surgical Instrument Service and Savings, Inc. | 2023-05-31 |
| Oxus Sieve Beds (K211056) | Oxus, Inc. | 2023-05-31 |
| Nihon Kohden NKV-440 Ventilator System (K222644) | Nihon Kohden Orangemed, Inc. | 2023-05-31 |
| EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) | Cook Ireland, Ltd. | 2023-05-30 |
| PrecisionTAVI (v1.1) (K223809) | Dasi Simulations | 2023-05-30 |
| First Glove Blue Nitrile Examination Gloves Powder Free (K230958) | First Glove Sdn. Bhd. | 2023-05-30 |
| Hydrozid Precise (K221897) | Bibawo Medical A/S | 2023-05-30 |
| Smith & Nephew ACCORD™ Cable System (K223762) | Smith & Nephew | 2023-05-30 |
| KBA3D (K223841) | S.M.A.I.O | 2023-05-30 |
| MyPAO Guides (K220706) | Medacta International S.A. | 2023-05-30 |
| Quicktome Software Suite (K222359) | Omniscient Neurotechnology Pty Ltd (O8t) | 2023-05-30 |
| Babyroo TN300 (K230278) | Draeger Medical Systems, Inc. | 2023-05-30 |
| RFP-100A Connector Cable (Single Use) (K230571) | Baylis Medical Technologies, Inc. | 2023-05-30 |
| Sonic DL (K223523) | Ge Medical Systems,Llc (Ge Healthcare) | 2023-05-30 |
| Excipio SV Aspiration Catheter and Tubing (K230030) | Contego Medical, Inc. | 2023-05-30 |
| Victan (K230593) | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2023-05-30 |
| Blue Nitrile Examination Gloves Powder Free (K230601) | Latrile Gloves Private Limited | 2023-05-28 |
| Kodiak Lumbar Spacer System (K230851) | Met One Technologies, LLC | 2023-05-26 |
| CD Horizon™ Spinal System (K231184) | Medtronic Sofamor Danek USA, Inc. | 2023-05-26 |
| Niti-S Biliary Speed D Stent (K223626) | Taewoong Medical Co., Ltd. | 2023-05-26 |
| Eclipse Treatment Planning System (v18.0) (K230557) | Varian Medical Systems, Inc. | 2023-05-26 |
| Cerebral Adaptive Index (CAI) Algorithm (K223651) | Edwards Lifesciences, LLC | 2023-05-26 |
| Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) (K223329) | Guangzhou Yongyi Industrial Co., Ltd. | 2023-05-26 |
| WellsForm Tricuspid Annuloplasty Band (WF) (K230679) | Genesee Biomedical, Inc. | 2023-05-26 |
| Finesse™ Injectable PTA Balloon Dilatation Catheter (K230263) | Summa Therapeutics, LLC | 2023-05-26 |
| FlexBand; FlexPatch; FlexBand Plus (K230316) | International Life Sciences | 2023-05-26 |