| EzDent Web (K230468) | Ewoosoft Co., Ltd. | 2023-04-21 |
| AEON Endoscopic Stapler (K222210) | Lexington Medical, Inc. | 2023-04-21 |
| ViewFinder Software Version 1.1 (K223501) | Elaitra, Ltd. | 2023-04-21 |
| Paradigm System (K222291) | Proprio, Inc. | 2023-04-21 |
| dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S (K222604) | Dentona AG | 2023-04-21 |
| Digital Intraoral X-Ray Sensor (K230811) | Iray Imaging Technology (Haining) Limited | 2023-04-21 |
| Anatase Spine Surgery Navigation System (K230783) | Remex Medical Corp. | 2023-04-21 |
| CONNEQT PULSE (K221742) | Atcor Medical | 2023-04-21 |
| Kyphoplasty Balloon System (K221142) | OK Medinet Korea Co., Ltd. | 2023-04-21 |
| OmniGuide RFID Surgical Laser Fibers (K230819) | Omni-Guide Holdings, Inc. | 2023-04-21 |
| Knee+ (K230789) | Pixee Medical | 2023-04-21 |
| HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K230084) | Samsung Medison Co., Ltd. | 2023-04-21 |
| Intense Pulsed Light Treatment System (K230816) | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 |
| Modular Rotating Hinge Knee Systems and Compatible Components (K223069) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-04-21 |
| PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808) | Kyocera Medical Technologies, Inc. | 2023-04-21 |
| HILINE™ Fixation System (K230565) | Globus Medical, Inc. | 2023-04-20 |
| Precision1, Precision1 for Astigmatism (K230785) | Alcon Laboratories, Inc. | 2023-04-20 |
| Flexible Video-Choledochoscope System (K222261) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-04-20 |
| SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981) | Fehling Surgical Instruments, Inc. | 2023-04-20 |
| Inomax DSIR (K211153) | Mallinckrodt Manufacturing, LLC | 2023-04-20 |
| ArtFX Spinal Fixation System (K212220) | Artfx Medical, LLC | 2023-04-20 |
| Velacur (K223287) | Sonic Incytes | 2023-04-20 |
| Breast Implant Removal Device (BIRD) (DEN220082) | Gaylord Solutions, LLC | 2023-04-20 |
| STARband 3D (K223238) | Orthomerica Products, Inc. | 2023-04-20 |
| Deep Learning Image Reconstruction (K230807) | Ge Healthcare Japan Corporation | 2023-04-20 |
| Neodent Implant System - Helix Short Surgical Kit Cases (K223662) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-04-20 |
| BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095) | Thrombolex, Inc. | 2023-04-20 |
| RadiForce RX270 (K223768) | Eizo Corporation | 2023-04-20 |
| TAP Lancet (K223201) | Yourbio Health, Inc. | 2023-04-19 |
| Altus Spine Monaco Pedicle Screw System (K230766) | Altus Spine | 2023-04-19 |
| Montross Extremity Medical Hemi Implant System (K221220) | Montross Extremity Medical | 2023-04-19 |
| Renova RP Centesis Pump (K221042) | Gi Supply, Inc. | 2023-04-19 |
| Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (K223552) | Brainlab AG | 2023-04-19 |
| Selux AST System; Model AST Gen 1.0 (K211748) | Selux Diagnostics, Inc. | 2023-04-19 |
| Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface (K223168) | Medtronic, Inc. | 2023-04-19 |
| Diode Laser Hair Removal (K230090) | Wuhan Lotuxs Technology Co., Ltd. | 2023-04-19 |
| SimpliFix Hip System (K230053) | Stabiliz Orthopaedics, Inc. | 2023-04-19 |
| ART-Plan (K230023) | Therapanacea Sas | 2023-04-19 |
| NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector (K220288) | Np Medical, Inc. | 2023-04-19 |
| SofWave System (K230820) | Sofwave Medical, Ltd. | 2023-04-18 |
| OsteoCentric Integrated Hip Fastener System (K230764) | OsteoCentric Technologies | 2023-04-18 |
| UniVy™ OsteoVy™-Ti Cervical IBF System (K223513) | Vy Spine, LLC | 2023-04-18 |
| Terumo Advanced Perfusion System 1 (K221895) | Terumo Cardiovascular Systems Corporation | 2023-04-18 |
| Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 (K223784) | Deltronix Equipamentos Ltda | 2023-04-18 |
| ClotTriever BOLD Catheter (K230494) | Inari Medical, Inc. | 2023-04-18 |
| Anivia SG1000 Pump Console (K230698) | Apmtd, Inc. | 2023-04-18 |
| SENSOSEEG Depth Electrodes (K213170) | Sensomedical Labs, Ltd. | 2023-04-18 |
| SnugFit All-Suture Anchor extension (K230544) | Medacta International S.A. | 2023-04-17 |
| Localite TMS Navigator TS (K223577) | Localite GmbH | 2023-04-17 |
| TIB Abutments (K222469) | Southern Implants (Pty), Ltd. | 2023-04-17 |
| NTX100 Tonic Motor Activation (NTX100 ToMAc) System (DEN220059) | Noctrix Health, Inc. | 2023-04-17 |
| TriMed Threaded Intramedullary Nail System (K230749) | TriMed, Inc. | 2023-04-17 |
| Custom-made Invisible Aligners (K223454) | Zhejiang Yinchili Medical Technology Co., Ltd. | 2023-04-17 |
| Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device (K230429) | Rapid Medical Ltd. | 2023-04-17 |
| Quantib Prostate (K230772) | Quantib B.V. | 2023-04-17 |
| X-CUBE 50, X-CUBE 60 (K223564) | Alpinion Medical Systems Co., Ltd. | 2023-04-17 |
| Curian® Shiga Toxin (K222829) | Meridian Bioscience, Inc. | 2023-04-17 |
| Masimo Rad-G with Temperature (K213676) | Masimo Corporation | 2023-04-16 |
| EpiFinder (K221974) | Omeq Medical , Ltd. | 2023-04-16 |
| TrachCuff Cuff Controller (K220854) | Aw Technologies Aps | 2023-04-14 |
| EndoflipTM 300 (K223705) | Covidien, LLC | 2023-04-14 |
| N9+ (K223785) | Nonagon , Ltd. | 2023-04-14 |
| BTL-094 (K221865) | BTL Industries, Inc. | 2023-04-14 |
| STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K220345) | Plasmapp Co,., Ltd. | 2023-04-14 |
| Compremium Compartment Compressibility Monitoring System (CPM#1) (K223509) | Compremium AG | 2023-04-14 |
| AutoContour Model RADAC V3 (K230685) | Radformation, Inc. | 2023-04-14 |
| Dragonfly OpStar™ Imaging Catheter (K230411) | ABBOTT MEDICAL | 2023-04-14 |
| LINK MobileLink Acetabular Cup System (K222066) | Waldemar Link GmbH & Co. KG | 2023-04-14 |
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| OSPREY PERIPHERAL IV Catheter System (K223018) | Skydance Vascular, Inc. | 2023-04-14 |
| NaviCam Xpress Stomach System, NaviCam Xpress System (K230694) | Anx Robotica Corp | 2023-04-13 |
| SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (K230868) | Maine Molecular Quality Controls, Inc. | 2023-04-13 |
| DESS Dental Smart Solutions (K230143) | Terrats Medical SL | 2023-04-13 |
| Ezra Flash (K230264) | Ezra Ai, Inc. | 2023-04-13 |
| AUTION MAX AX-4060 Urinalysis System (K193514) | Arkray, Inc. | 2023-04-13 |
| Symmed Elite Aesthetic (K230412) | Termosalud | 2023-04-13 |
| CIRRUS HD-OCT (K222200) | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (K223879) | Quara S.R.L. | 2023-04-13 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K223435) | Abbott Diabetes Care, Inc. | 2023-04-13 |
| Point implant system (K222738) | Pointnix Co., Ltd. | 2023-04-13 |
| UniCam Evo Software (K230393) | Inter Medical Medizintechnik GmbH | 2023-04-13 |
| Trusana™ (K230098) | Myerson, LLC | 2023-04-13 |
| Stratus Infusion Catheter (K222185) | Intervene, Inc. | 2023-04-13 |
| ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) (K230387) | Ethicon Endo-Surgery, LLC | 2023-04-13 |
| BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (K230719) | Biofire Diagnostics, LLC | 2023-04-13 |
| CerebralGo Plus (K213986) | Yukun (Beijing) Technology Co., Ltd. | 2023-04-13 |
| ALPCO Calprotectin Immunoturbidimetric Assay (K220763) | ALPCO | 2023-04-13 |
| Sterile Nitrile Surgical Gloves Powder Free (K222350) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2023-04-13 |
| ADSEAL Plus (K230010) | Meta Biomed Co., Ltd. | 2023-04-13 |
| Task Force CORE (K223332) | Cnsystems Medizintechnik GmbH | 2023-04-12 |
| Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (K230424) | Omnia Medical, LLC | 2023-04-12 |
| Polyfusion IV Administration Sets (K220312) | Poly Medicure Limited | 2023-04-12 |
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
| ZeptoLink IOL Positioning System (K223763) | Centricity Vision, Inc. | 2023-04-11 |
| L12 LED Light Source with AIM (K230754) | Stryker | 2023-04-11 |
| POT PTCA Balloon Dilatation Catheter (K230705) | Brosmed Medical Co., Ltd. | 2023-04-11 |
| Augmento (K222781) | Deeptek Medical Imaging Private Limited | 2023-04-11 |
| Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (K223530) | Route 92 Medical, Inc. | 2023-04-11 |
| Eagle S/Saevo Slim/D700 Slim (K230732) | Alliage S/A Industrias Medica Odontológico. | 2023-04-11 |
| Bronchoscope System (K222910) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-04-11 |