| SimPro™ Now, GentleCath™ Hydrophilic (K223756) | Dentsply Sirona | 2023-05-04 |
| Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (K230653) | Smith & Nephew, Inc. | 2023-05-04 |
| Auto Segmentation (K230082) | Ge Medical Systems, LLC | 2023-05-04 |
| OLYMPIC Deformity Band System (K222097) | Astura Medical | 2023-05-04 |
| Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245) | Nucleix , Ltd. | 2023-05-04 |
| Epione (K223758) | Quantum Surgical Sas | 2023-05-03 |
| ARIX Humerus System (K230938) | Jeil Medical Corporation | 2023-05-03 |
| PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw (K230655) | Signature Orthopaedics Pty, Ltd. | 2023-05-03 |
| MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743) | Medschenker, Inc. | 2023-05-03 |
| Sphincterotome (K222421) | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 |
| FloPatch FP120 (K223843) | Flosonics Medical | 2023-05-03 |
| BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (K230948) | Verathon Medical (Canada) Ulc | 2023-05-03 |
| Apollo Knotless Suture Anchor (K230123) | Maruho Medical | 2023-05-03 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K230934) | ABBOTT MEDICAL | 2023-05-03 |
| Dentis I-FIX Abutment (K230203) | Dentis Co., Ltd. | 2023-05-03 |
| 3D Anatomic Model (K230119) | Ricoh USA, Inc. | 2023-05-02 |
| AcQMap® High Resolution Imaging and Mapping System (K230606) | Acutus Medical, Inc. | 2023-05-02 |
| Zeolite Hemostatic Cotton (K223495) | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 |
| SIS System (K230977) | Surgical Information Sciences, Inc. | 2023-05-02 |
| CoreLink Navigation Instruments (K230880) | Corelink, LLC | 2023-05-02 |
| FortiShield (Biosynthetic Wound Matrix) (K212579) | Organogenesis, Inc. | 2023-05-02 |
| Excella Navigation Instruments (K223511) | Innovasis, Inc. | 2023-05-02 |
| NuEra Tight RF Model APMD145.M70-US (K223907) | Bios S.R.L. | 2023-05-02 |
| Cortium™ (K230614) | Ulrich Medical USA | 2023-05-02 |
| ASEPT Peritoneal Drainage System (K221779) | Pfm Medical, Inc. | 2023-05-02 |
| TriSalus TriNav® LV Infusion System (K230957) | Trisalus Life Sciences | 2023-05-02 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) | Samsung Electronics Co., Ltd. | 2023-05-02 |
| PressON Spinal Fixation System (K223529) | Nexus Spine, LLC | 2023-05-02 |
| Artix BG (K230912) | Inari Medical | 2023-05-02 |
| RIA Safeguard (K222416) | Ria Tech Co., Ltd. | 2023-05-01 |
| CP620G LCD monitor, CP620 LCD monitor (K230643) | Nanjing Jusha Display Technology Co., Ltd. | 2023-05-01 |
| Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy (K223182) | Worldwork S.R.L | 2023-05-01 |
| CarnaLife Holo (K221870) | Medapp S.A. | 2023-05-01 |
| vPATCH (K223595) | Virility Medical , Ltd. | 2023-05-01 |
| Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp (K223862) | Wontech Co., Ltd. | 2023-04-28 |
| Bladeless Trocar – Artemis Lap Cannula (K230058) | T.A.G. Medical Products Corporation, Ltd. | 2023-04-28 |
| Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (K230597) | Light Tree Ventures Europe B.V. | 2023-04-28 |
| Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480) | Teleflex Medical | 2023-04-28 |
| BNLE Access Guidewire (K221390) | Biomerics Nle | 2023-04-28 |
| Q-Rejuvalight Pro Facewear (Model: P19-0023) (K230042) | Light Tree Ventures Europe B.V. | 2023-04-28 |
| ET Abutment System (K222636) | Hiossen, Inc. | 2023-04-28 |
| Kurin Blood Culture Collection Set with Kurin Lock Technology (K220677) | Kurin, Inc. | 2023-04-28 |
| VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K230600) | Spectrum Dynamics Medical, Ltd. | 2023-04-28 |
| Titanium Abutment Blank Nobel Biocare N1 TCC (K223677) | Nobel Biocare AB | 2023-04-28 |
| Hand Trauma Threaded Nail System (K230908) | Skeletal Dynamics, Inc. | 2023-04-28 |
| Nanox.ARC (K222934) | Nano-X Imaging , Ltd. | 2023-04-28 |
| Customized Abutment (K223634) | Arum Dentistry Co., Ltd. | 2023-04-28 |
| Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (K213825) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023-04-28 |
| Ingenia Elition and MR 7700 MR Systems (K230972) | Philips Medical Systems Nederland B.V. | 2023-04-28 |
| INTEGRATE -C Interbody Fusion System (K222004) | Happe Spine | 2023-04-28 |
| ArtiSential Laparoscopic Instruments-Electrodes (K230539) | Livsmed, Inc. | 2023-04-27 |
| Renuvion® APR Handpiece (K230272) | Apyx Medical Corporation | 2023-04-27 |
| Epildream HP 4000 MED (K222352) | D.E.A Project S.R.1. | 2023-04-27 |
| DentMix VPS Impression Material (K223892) | Innovative Product Brands, Inc. | 2023-04-27 |
| UNIDRIVE SIII System (K223520) | Karl Storz-Endoscopy-America, Inc. | 2023-04-27 |
| PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter (K230547) | Conmed Corporation | 2023-04-27 |
| ENT EM (K223734) | Brainlab AG | 2023-04-27 |
| Myolift QT (K213078) | Johari Digital Healthcare Limited | 2023-04-27 |
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (K222381) | Stryker GmbH | 2023-04-27 |
| ClotTriever XL Catheter (K223210) | Inari Medical, Inc. | 2023-04-27 |
| Braun Skin i.expert (K230911) | Cyden Limited | 2023-04-27 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color (K221983) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-04-27 |
| 32HL512D, 31HN713D, 32HQ713D (K230845) | Lg Electronics.Inc | 2023-04-27 |
| Cumulus Functional Neurophysiology Platform (K221963) | Cumulus Neuroscience Limited | 2023-04-27 |
| Gastric Alimetry System (K223398) | Alimetry , Ltd. | 2023-04-27 |
| Precision DL (K223212) | GE Healthcare | 2023-04-27 |
| Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert (K230844) | Conformis, Inc. | 2023-04-27 |
| TENS7000 Rechargeable (Model:TENS7000 Rechargeable) (K230829) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2023-04-26 |
| ArtiSential Laparoscopic Instruments-Electrodes (K230499) | Livsmed, Inc. | 2023-04-26 |
| MR DWI/FLAIR Measurement V1.0 (K230552) | Olea Medical | 2023-04-26 |
| Endo Motor (K222548) | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 |
| PYXIS 3D Titanium Cage System (K223868) | GS Medical Co., Ltd. | 2023-04-26 |
| EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 (K222584) | Olympus Medical Systems Corporation | 2023-04-26 |
| LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553) | Medtronic, Inc. | 2023-04-26 |
| SafeAir combi (SFR-combi-US) (K223932) | Lina Medical Aps | 2023-04-26 |
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Ceevra Reveal 3 (K222676) | Ceevra, Inc. | 2023-04-25 |
| MiVu™ Esophageal Endo Cap (K230056) | Diversatek Healthcare | 2023-04-25 |
| Konicaminolta DI-X1 (K230906) | Konica Minolta, Inc. | 2023-04-25 |
| DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (K230218) | Dental Direkt GmbH | 2023-04-25 |
| Wallaby 017 Micro Catheter (K223139) | Wallaby Medical | 2023-04-25 |
| Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503) | Boston Scientific | 2023-04-25 |
| NITRO Interbody Fusion Cage System Family (K220513) | Ctl Medical Corporation | 2023-04-25 |
| TMINI™ Miniature Robotic System (K230202) | THINK Surgical, Inc. | 2023-04-25 |
| IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG (K230549) | Shenzhen Xiazhifeng Electronic Co., Ltd. | 2023-04-25 |
| Tigereye ST CTO-Crossing Catheter (K230594) | Avinger, Inc. | 2023-04-25 |
| iCAC Device (K230223) | Bunkerhill, Inc. | 2023-04-25 |
| ALPHALOK Plating System (K230204) | Vilex, LLC | 2023-04-25 |
| Kisar Stratford SI Screw System (K220274) | Anjali Investments L.L.C | 2023-04-24 |
| Omnipod GO Insulin Delivery Device (K223372) | Insulet Corporation | 2023-04-24 |
| The Heart Seat (K222330) | Casana Care, Inc. | 2023-04-24 |
| TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (K230140) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| RAIN Sheath™ Tibial Pedal Introducer (K230704) | Cordis US Corp | 2023-04-24 |
| Klockner Abutments (K230103) | SOADCO, S.L. | 2023-04-24 |
| NEST-C Interbody System (K220261) | Paonan Biotech Co., Ltd. | 2023-04-24 |
| TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| STR8 Clear Aligner (K223141) | Str8 Oral Care | 2023-04-24 |
| SmartGUIDE deflectable hydrophilic guidewire (K222690) | Artiria Medical SA | 2023-04-24 |
| Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument (K223300) | Geotek Medikal Ltd Sti | 2023-04-21 |