| MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (K232154) | MiRus, LLC | 2023-09-11 |
| TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System (K231504) | Vilex, LLC | 2023-09-11 |
| Venus Versa PRO System (K232192) | Venus Concept, Inc. | 2023-09-11 |
| SiteRite™ 9 Ultrasound System (K231283) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 |
| VERIFY Spore Test Strip for S40 Sterilant Concentrate (K231746) | STERIS Corporation | 2023-09-11 |
| Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) (K230517) | Jarmon Medical, LLC (Dba Legends Orthopedics) | 2023-09-11 |
| i-STAT G cartridge with the i-STAT 1 System (K223755) | Abbott Point of Care, Inc. | 2023-09-11 |
| Planar LED mate (K230362) | Shenzhen Leaflife Technology Co., Ltd. | 2023-09-11 |
| Vantage® Total Ankle System (K232002) | Exactech, Inc. | 2023-09-11 |
| Change Healthcare Cardiology Hemodynamics™ (K230881) | Change Healthcare Israel , Ltd. | 2023-09-11 |
| Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (K223864) | Brainlab AG | 2023-09-09 |
| VariSeed (v10) (K232400) | Varian Medical Systems | 2023-09-08 |
| FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (K223827) | Fujifilm Corporation | 2023-09-08 |
| PreXion3D Expedition (K232166) | Prexion Corporation | 2023-09-08 |
| VitreJect Syringe (K230372) | Ocuject, LLC | 2023-09-08 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (K232426) | Conformis, Inc. | 2023-09-08 |
| DeepXray (K223621) | Alpha Intelligence Manifolds, Inc. | 2023-09-08 |
| Sterile Hypodermic Needles for Single Use (K231720) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| AliTight (K231146) | Alic Iotech, LLC | 2023-09-08 |
| OnPoint Augmented Reality Spine System (K231284) | Onpoint Surgical, Inc. | 2023-09-08 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K231643) | Syntex Healthcare Products Co., Ltd. | 2023-09-08 |
| Sterile Auto-Disable Syringes with/without Needle for Single Use (K231727) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| MaxTack™ Motorized Fixation Device (K231240) | Covidien | 2023-09-08 |
| Intrisound™ Tuned Lumen® 155 Hearing Aids (K223848) | Tuned , Ltd. | 2023-09-08 |
| STarFix Designer Software C0265 (K231141) | FHC, Inc. | 2023-09-08 |
| Minuteful-kidney test (K222921) | Healthy.Io, Ltd. | 2023-09-08 |
| Sterile syringes for single use with/without needle (K231729) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| Sterile Safety Hypodermic Needles for Single Use (K231723) | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| CorVista® System (K232686) | Corvista Health, Inc. | 2023-09-08 |
| Cleerly ISCHEMIA (K231335) | Cleerly, Inc. | 2023-09-08 |
| STAT Medical Device Lancing System (K230310) | Stat Medical Devices | 2023-09-08 |
| Air/Water Bottle Tubing, CO2 Source Tubing (K231471) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| Fusion Robotic Navigation System (K232413) | Alphatec Spine, Inc. | 2023-09-08 |
| ISE Electrodes (K230890) | Randox Laboratories, Ltd. | 2023-09-08 |
| ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (K232386) | ABBOTT MEDICAL | 2023-09-08 |
| Q-FIX ULTRA All-Suture Anchor (K232457) | Smith & Nephew | 2023-09-08 |
| KARL STORZ Urological Laser Accessories (K230535) | Karl Storz SE & CO. KG | 2023-09-08 |
| Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post (K232414) | Total Joint Othopedics, Inc. | 2023-09-08 |
| Zeta Cranial Navigation System (K230661) | Zeta Surgical | 2023-09-08 |
| Arm Blood Pressure Monitor (K230649) | Alicn Medical Shenzhen, Inc. | 2023-09-07 |
| Pounce™ Sheath (K231828) | Surmodics,Inc. | 2023-09-07 |
| SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (K230049) | Ttk Healthcare Limited | 2023-09-07 |
| CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207) | Biosense Webster, Inc. | 2023-09-07 |
| IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 (K231800) | Shenzhen Qianyu Technology Co., Ltd. | 2023-09-07 |
| Steriking® LT-Blueline Pouches with Tyvek® (K231999) | Wipak OY | 2023-09-07 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K232443) | Argon Medical Devices, Inc. | 2023-09-07 |
| Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes (K221743) | Jiangsu Bonss Medical Technology Co., Ltd. | 2023-09-07 |
| Digital Blood Pressure Monitor WBP Series (K231542) | Weony (Shenzhen) Technology Co., Ltd. | 2023-09-07 |
| AeroDVx Arm System (K222823) | Sun Scientific, Inc. | 2023-09-07 |
| Signum opaque F (K230644) | Kulzer, LLC | 2023-09-07 |
| Steriking® LT-Blueline Pouches with Tyvek® (K231996) | Wipak OY | 2023-09-07 |
| Gradual Dental Zirconia Blank (K231687) | Liaoning Upcera Co., Ltd. | 2023-09-07 |
| Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (K232389) | Masimo Corporation | 2023-09-07 |
| Phoenix ICON, Phoenix ICON GO (K223575) | Neolight, LLC | 2023-09-06 |
| IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 (K231717) | Foshan Jindi Electric Appliance Co., Ltd. | 2023-09-06 |
| Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible (K230127) | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 |
| IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K230824) | Art Optical Contact Lens, Inc. | 2023-09-06 |
| HI-EMT MAGSHAPE (K230024) | Beijing Sano Laser S&T Development Co.,Ltd | 2023-09-06 |
| MAGNETOM Viato.Mobile (K232482) | Siemens Medical Solutions USA, Inc. | 2023-09-06 |
| esolution (DEN230006) | S4 Medical Corp. | 2023-09-06 |
| Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL (K200583) | Ki Mobility, LLC | 2023-09-05 |
| VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197) | Ortho Clinical Diagnostics | 2023-09-05 |
| ICHOR 14F Embolectomy System (K230743) | Ichor | 2023-09-05 |
| BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (K221869) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 |
| F&P 820 Humidification System (K223684) | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 |
| Promaxo MRI System II (K232361) | Promaxo, Inc. | 2023-09-05 |
| Polibond (K232691) | Zirkonzahn Srl | 2023-09-05 |
| Ki Power Tilt System (K201869) | Ki Mobility, LLC | 2023-09-05 |
| Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K231819) | Innovate Orthopaedics Limited | 2023-09-05 |
| HyperLight Portable X-ray Unit (K232068) | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 |
| UniSyn Molecular Imaging (6-3-1) (K231047) | Convergent Imaging Solutions | 2023-09-01 |
| OW100S (K231710) | Softwave/Trt, LLC | 2023-09-01 |
| LightStrike+ (MXSUV1-SL and MXSUV1-FT) (DEN230007) | Xenex Disinfection Services, Inc. | 2023-09-01 |
| InnerView LC (K232657) | Perimetrics, Inc. | 2023-09-01 |
| Montage Flowable Settable, Resorbable Bone Paste (K231270) | Orthocon, Inc. | 2023-09-01 |
| Elos Accurate Hybrid Base (K230317) | Elos Medtech Pinol A/S | 2023-09-01 |
| TRIOCLEAR System (K231884) | Modern Dental Laboratory (Dg) Co., Ltd. | 2023-09-01 |
| CONDUIT™ ATP Inserters (K232014) | Enztec Limited | 2023-09-01 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK) (K223622) | Faceheart Corp. | 2023-09-01 |
| ApneaRX Pro (K223901) | Apnea Sciences Coporation | 2023-09-01 |
| Brain Anesthesia Response Monitor (Bar Monitor) (K213273) | Cortical Dynamics , Ltd. | 2023-09-01 |
| KITE Distal Fibula Kit (K230623) | Intrauma S.P.A | 2023-09-01 |
| MasterX 800 Series (K230918) | Medicatech USA | 2023-09-01 |
| Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor (K232340) | Arthrex, Inc. | 2023-09-01 |
| Hemostatic Dressing (K213413) | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 |
| Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (K232314) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 |
| MS-39 (K221601) | C.S.O. S.R.L. | 2023-09-01 |
| eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (K223674) | Epic Medical Pte. , Ltd. | 2023-09-01 |
| neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (K222988) | Ht Medical D.B.A. Xenix Medical | 2023-09-01 |
| Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (K232021) | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 |
| DEKA SIMON (K232334) | El.En S.P.A. | 2023-09-01 |
| TriMed Clavicle Fixation System (K230805) | TriMed, Inc. | 2023-09-01 |
| Ancora-SB (K231323) | Aspero Medical, Inc. | 2023-08-31 |
| Powder Free Nitrile Examination Gloves (Black) (K232353) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-08-31 |
| 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (K223597) | 23AndMe, Inc. | 2023-08-31 |
| Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K230578) | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 |
| RAYSCAN a-Expert3D (K232287) | Ray Co., Ltd. | 2023-08-31 |
| MedicloseTM System (K213271) | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 |
| BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 (K231978) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 |