| LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245) | L&K BIOMED Co., Ltd. | 2023-02-28 |
| VIOLA (K230248) | Vascular Graft Solutions, Ltd. | 2023-02-28 |
| SurBlate Ablation System (K223272) | Mima-Pro Scientific, Inc. | 2023-02-28 |
| AccuICAS (K221711) | ArteryFlow Technology Co., Ltd. | 2023-02-28 |
| SpectraWAVE Imaging System (K221257) | Spectrawave, Inc. | 2023-02-28 |
| MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) (K230038) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 |
| Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (K223253) | Arum Dentistry Co., Ltd. | 2023-02-27 |
| Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173) | Saneso, Inc. | 2023-02-27 |
| Idylla MSI Test (K211181) | Biocartis NV | 2023-02-27 |
| Ogmend® Implant Enhancement System (K223075) | Woven Orthopedic Technologies | 2023-02-27 |
| Milli Vaginal Dilator (K220035) | Materna Medical | 2023-02-27 |
| BENCOX Mirabo Z Cup Cortinium (K223223) | Corentec Co., Ltd. | 2023-02-27 |
| Handheld Pulse Oximeter (K213431) | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023-02-26 |
| CompuFlo Epidural Computer Controlled Anesthesia System (K221702) | Milestone Scientific, Inc. | 2023-02-25 |
| ELITONE Urge Urinary Incontinence Device (K223884) | Elidah, Inc. | 2023-02-24 |
| VySpan™ PCT System (K223852) | Vy Spine, LLC | 2023-02-24 |
| AVIEW Lung Nodule CAD (K221592) | Coreline Soft Co., Ltd. | 2023-02-24 |
| Ti-Largo Cervical Interbody System (K223231) | Flospine | 2023-02-24 |
| Visionbody (K222386) | Vb Technologies AG | 2023-02-24 |
| EsoCheck Cell Collection Device (K230339) | Lucid Diagnostics, Inc. | 2023-02-24 |
| Arthrex SynergyID Endoscopic Imaging System (K223759) | Arthex, Inc. | 2023-02-24 |
| Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (K221845) | Blue Sky Bio, LLC | 2023-02-24 |
| RealNow (K213891) | Yiwei Medical Technology Co., Ltd. | 2023-02-24 |
| MectaLock TI Triple Loaded Suture Anchor (K223582) | Medacta International S.A. | 2023-02-24 |
| Clarus Viewer (K222757) | Clarus Viewer Corporation | 2023-02-24 |
| Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K223810) | Sb-Kawasumi Laboratories, Inc. | 2023-02-24 |
| Veloxion System (K230205) | Corinth Medtech, Inc. | 2023-02-24 |
| MAGNETOM Vida (K213805) | Siemens Medical Solutions USA, Inc. | 2023-02-24 |
| Caption Interpretation Automated Ejection Fraction Software (DEN220063) | Caption Health, Inc. | 2023-02-24 |
| Pill Sense System (DEN220065) | Enterasense , Ltd. | 2023-02-24 |
| InnoGenic Non-resorbable Membrane (K211554) | Cowellmedi Co., Ltd. | 2023-02-24 |
| TytoCare Lung Sounds Analyzer (K221614) | Tyto Care , Ltd. | 2023-02-24 |
| babyLance Safety Heelstick (BLM, BLN, BLP) (K223900) | Clinical Innovations, LLC | 2023-02-24 |
| Elekta Unity (K223209) | Elekta Solutions AB | 2023-02-23 |
| Neuro20 Pro System (K223797) | Neuro20 Technologies | 2023-02-23 |
| Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228) | Iridex Corporation | 2023-02-23 |
| Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 (K221559) | Stringking | 2023-02-23 |
| Renuvion® APR Handpiece (K223262) | Apyx Medical Corporation | 2023-02-23 |
| Brainomix 360 e-ASPECTS (K221564) | Brainomix Limited | 2023-02-23 |
| Symphony Thrombectomy System (K223216) | Truvic Medical, Inc. | 2023-02-23 |
| Belun Sleep System BLS-100 (K222579) | Belun Technology Company Limited | 2023-02-23 |
| 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (K230216) | Stryker | 2023-02-23 |
| Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591) | Schoelly Fiberoptic GmbH | 2023-02-23 |
| LED light therapy mask (FM-01, FM-02, FM-03) (K223544) | Guangdong Newdermo Biotech Co., Ltd. | 2023-02-23 |
| Jumong General (K230241) | Sg Healthcare Co, Ltd. | 2023-02-23 |
| T-Line Hernia Mesh (K230227) | Deep Blue Medical Advances, Inc. | 2023-02-23 |
| OXY-1 System (K223161) | Abiomed, Inc. | 2023-02-23 |
| MOSAIQ® OIS (Oncology Information System) (K223229) | Elekta Solutions AB | 2023-02-23 |
| Everion+ System (K213863) | Biofourmis Singapore Pte., Ltd. | 2023-02-23 |
| OrthoButton AL (K230212) | Riverpoint Medical, LLC | 2023-02-23 |
| Monaco RTP System (K223233) | Elekta Solutions AB | 2023-02-23 |
| 3D-RD-S (K212587) | Radiopharmaceutical Imaging and Dosimetry, LLC | 2023-02-22 |
| Disposable Pre-calibrated Brain Biopsy Needle 2.0 (K230201) | PAJUNK GmbH Medizintechnologie | 2023-02-22 |
| Swoop® Portable MR Imaging System™ (K230208) | Hyperfine, Inc. | 2023-02-22 |
| TRAUS Air Dental Handpiece (K221741) | Saeshin Precision Co., Ltd. | 2023-02-22 |
| eFOLDi Scooter, Lite (K223492) | Suntech UK , Ltd. | 2023-02-22 |
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629) | Covidien | 2023-02-22 |
| PATI (Protector Against Tongue Injury) (K221469) | Neurovice, LLC | 2023-02-22 |
| Rosa Knee System (K230180) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-02-22 |
| The Alma Soprano Titanium (K230371) | Alma Lasers, Inc. | 2023-02-22 |
| Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (K223298) | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 |
| BoneMRI v1.6 (K230197) | Mriguidance B.V. | 2023-02-22 |
| Eyer Retinal Camera NM-STD (K221329) | Phelcom Technologies | 2023-02-22 |
| NEONA 1.5T MRI System (K222259) | Time Medical Limited | 2023-02-21 |
| Introducer Sheath Kits (K222184) | Beijing Demax Medical Technology Co.,Ltd | 2023-02-21 |
| FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537) | Abbott Diabetes Care, Inc. | 2023-02-21 |
| Verifine® Ease Lancing Device, Verifine® Lancing Device (K223643) | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 |
| Quantia IgE (K214068) | Biokit, S.A. | 2023-02-21 |
| Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (K223612) | Ranfac Corporation | 2023-02-21 |
| BOND MMR Antibody Panel (K213348) | Leica Biosystems Newcastle, Ltd. | 2023-02-21 |
| FloNavi Endoscopic Fluorescence Imaging System (K221861) | Guangdong Optomedic Technologies, Inc. | 2023-02-18 |
| Painless IPL System - KDT750 (K220214) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 |
| troCarWash™ System (K222695) | Biotex, Inc. | 2023-02-17 |
| Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (K213755) | Gbs Commonwealth Co., Ltd. | 2023-02-17 |
| DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (K222977) | Macromedics BV | 2023-02-17 |
| EzDent-i / E2 / Prora View/ Smart M Viewer (K223820) | Ewoosoft Co., Ltd. | 2023-02-17 |
| Doctor Tecar Plus, Doctor Tecar Smart (K221043) | Mectronic Medicale S.R.L. | 2023-02-17 |
| Excipio LV Thrombectomy Device (K223897) | Contego Medical, Inc. | 2023-02-17 |
| Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 (K222588) | Iweecare Co., Ltd. | 2023-02-17 |
| FlowSaver Blood Return System (K221483) | Inari Medical, Inc. | 2023-02-17 |
| Equashield Closed System Transfer Device (K221513) | Equashield Medical , Ltd. | 2023-02-17 |
| Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 (K223466) | STERIS Corporation | 2023-02-17 |
| ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device (K222971) | Smith & Nephew, Inc. | 2023-02-17 |
| Infrared Thermometer TET-351 (K220276) | Truly Instrument Limited | 2023-02-17 |
| APRO 70 Catheter and Alembic Aspiration Tubing (K223545) | Alembic, LLC | 2023-02-17 |
| Glidewell TuffSplint™ Appliance Resin (K223798) | Prismatik Dentalcraft, Inc. | 2023-02-17 |
| PMD-200 (DEN210022) | Medasense Biometrics , Ltd. | 2023-02-17 |
| EON (K222226) | Dominion Aesthetic Technologies, Inc. | 2023-02-17 |
| Spectrum Saliva Collection Device (K223497) | Spectrum Solutions, LLC | 2023-02-17 |
| PROstep(TM) MIS 5mm Chamfer Screw System (K221645) | Wright Medical Technology | 2023-02-17 |
| PMMA Blocks for Dental Use (K223477) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 |
| Sonopet 1Q 3 7cm 1Q Large (K223770) | Stryker Corporation | 2023-02-16 |
| CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (K223733) | Biosense Webster, Inc. | 2023-02-16 |
| VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478) | bioMerieux, Inc. | 2023-02-16 |
| Surgical Gown (K213844) | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023-02-16 |
| Vivid S60N, Vivid S70N (K223832) | Ge Medical System Ultrasound and Primary Care Diagnostics | 2023-02-16 |
| Bony Trauma Extremity System (BTES) Screw Range, NX Nail (K230118) | Field Orthopaedics Pty, Ltd. | 2023-02-16 |
| JAWS Nitinol Staple System (K223056) | Paragon 28, Inc. | 2023-02-16 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |