| KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (K233333) | Karl Storz SE & CO. KG | 2023-11-21 |
| TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (K233049) | Cs Medical, LLC | 2023-11-21 |
| ProMIS Extension Rod System (K232719) | Premia Spine, Ltd. | 2023-11-21 |
| Ultrasonic Scaler Tips (K230641) | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-21 |
| SaviSafe Safety Device (K230287) | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 |
| Quantisal™ Oral Fluid Collection Device (K232898) | Immunalysis Corporation | 2023-11-21 |
| Biophotas Celluma CONTOUR (K232977) | Biophotas, Inc. | 2023-11-21 |
| DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor (K233053) | Dental Imaging Technologies Corporation | 2023-11-21 |
| MagnetOs Flex Matrix (K233245) | Kuros Biosciences B.V | 2023-11-21 |
| Meta G UCLA Abutment (K232546) | Cowellmedi Co., Ltd. | 2023-11-21 |
| Brainomix 360 Triage Stroke (K232496) | Brainomix Limited | 2023-11-21 |
| Medical Nitrile Examination Gloves (K232576) | Jiangsu Complete Sincerity Medical New Materials Co., Ltd. | 2023-11-21 |
| Nu Skin RenuSpa iO (K232001) | Nse Products, Inc. | 2023-11-21 |
| Beagank 4T Plus (K233010) | Belega, Inc. | 2023-11-21 |
| TraumaCad Neo (K231498) | Brainlab , Ltd. | 2023-11-20 |
| Ziehm Vision RFD (K231692) | Ziehm Imaging GmbH | 2023-11-20 |
| Zilia Ocular FC (ZIL-10002) (K230627) | Zilia, Inc. | 2023-11-20 |
| The SensiTox B. anthracis Toxin Test (K232545) | First Light Diagnostics, Inc. | 2023-11-20 |
| Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force (K233351) | Hg Innovations, Ltd. | 2023-11-20 |
| ARIETTA x10 (K231941) | FUJIFILM Healthcare Americas Corporation | 2023-11-20 |
| Harmony (K232555) | Topcon Healthcare Solutions | 2023-11-20 |
| Hair Removal Device, Model(s): R2815-G Pro, R2815-G (K232575) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2023-11-20 |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); (K233346) | Hg Innovations, Ltd. | 2023-11-20 |
| RIWOtrack Navigation System (K230700) | Fiagon GmbH | 2023-11-20 |
| Masimo W1 (K232512) | Masimo Corporation | 2023-11-17 |
| Celox Rapid X-Ray Gauze (K230589) | Medtrade Products , Ltd. | 2023-11-17 |
| Alinity c Tricyclic Antidepressants Reagent Kit (K231020) | Microgenics Corporation | 2023-11-17 |
| SENDERO Microcatheter (K231600) | Okami Medical, Inc. | 2023-11-17 |
| Polyver Silver Alginate Dressing (Prescription and OTC) (K230190) | Roosin Medical Co., Ltd. | 2023-11-17 |
| Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) (K232028) | Iq Endoscopes Limited | 2023-11-17 |
| Samfilcon B Custom Contact Lens (K230954) | Bausch + Lomb, Incorporated | 2023-11-17 |
| DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL (K232538) | Wrp Asia Pacific Sdn. Bhd. | 2023-11-17 |
| Gastric Alimetry System (K232925) | Alimetry , Ltd. | 2023-11-17 |
| Edwards Algorithm for Measurement of Blood Hemoglobin (K230612) | Edwards Lifesciences, LLC | 2023-11-17 |
| Multi-Unit DAS System (K231559) | Talladium España, SL | 2023-11-17 |
| AI Platform (AIP001) (K232501) | Exo, Inc. | 2023-11-17 |
| EKGenius Smart System (K232974) | Ekgenius, LLC | 2023-11-17 |
| ExactechGPS® Total Ankle Application (K232521) | Blue Ortho | 2023-11-16 |
| Vital™ Navigation System (K233443) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-11-16 |
| MASADA Modular Spinal Fixation System (K231694) | Astura Medical | 2023-11-16 |
| DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric (K232921) | Alcon Laboratories, Inc. | 2023-11-16 |
| ROSA Partial Knee System (K232533) | Orthosoft D/B/A Zimmer Cas | 2023-11-16 |
| OSSIOfiber® Compression Staple (K233302) | OSSIO , Ltd. | 2023-11-16 |
| Trio-CT® Triple Lumen Catheter w/ Curved Extensions (K232945) | Medical Components, Inc. (dba MedComp) | 2023-11-16 |
| CT Lung Ventilation Analysis Software (CT:V) (K232392) | 4Dmedical Limited | 2023-11-16 |
| LINK Embrace Shoulder System - Reverse Configuration (K231445) | Waldemar Link GmbH & Co. KG | 2023-11-16 |
| NEUWAVE™ Microwave Ablation System and Accessories (K231738) | Neuwave Medical, Inc. | 2023-11-16 |
| Aptima® Chlamydia trachomatis Assay (K230451) | Hologic, Inc. | 2023-11-16 |
| EXPD 4343D; EXPD 3643D (K232753) | DRTECH Corporation | 2023-11-16 |
| Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K232139) | Innova Vision, Inc. | 2023-11-16 |
| D100 KIDS; D101 KIDS (K231652) | Sorin Group Italia S.R.L. | 2023-11-16 |
| XPLUS 35 Series (XPLUS 35, XPLUS 35FD) (K233200) | GEMSS HEALTHCARE CO., LTD. | 2023-11-16 |
| METIC™- Airway Balloon Catheter (K231818) | M/S Meril Life Sciences Pvt. , Ltd. | 2023-11-15 |
| Axial3D Insight (K232841) | Axial Medical Printing Limited | 2023-11-15 |
| Simple 2 Test (DEN200070) | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023-11-15 |
| BinkieRT (K231852) | Papricalab | 2023-11-15 |
| Arthrex Knee FiberTak® Button Suture Anchor (K232973) | Arthrex, Inc. | 2023-11-15 |
| NSite Scoliosis Assessment App (K230463) | Nsite, Inc. | 2023-11-15 |
| Curing Light, Model: MaxCure 9 (K223414) | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 |
| CoolSeal Trinity (K231012) | Bolder Surgical, LLC | 2023-11-15 |
| UniPearls® Embolic Microspheres (K231554) | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 |
| saremco print BRIDGETEC (K232050) | Saremco Dental AG | 2023-11-14 |
| VitroPRO (K231783) | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| IPL Cooling Hair Removal Device (K232845) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2023-11-14 |
| MAGNETOM Avanto fit; MAGNETOM Skyra fit (K232494) | Siemens Medical Solutions USA, Inc. | 2023-11-14 |
| Great Basin Toxigenic C. difficile Direct Test (CDF2) (K232092) | Vela Operations USA | 2023-11-14 |
| Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) (K233434) | Prismatik Dentalcraft, Inc. | 2023-11-14 |
| BrainSpec Core™ Software (K230856) | Brainspec, Inc. | 2023-11-14 |
| Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis (K232461) | Kossan International Sdn Bhd | 2023-11-14 |
| Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems (K231097) | Prismatik Dentalcraft, Inc. | 2023-11-14 |
| BLU TOTALE (Model: ENEOB852) (K232656) | Premier North America, Inc. | 2023-11-14 |
| Broncho Videoscope System (K231521) | Scivita Medical Technology Co., Ltd. | 2023-11-14 |
| Iconix Anchor (K233468) | Riverpoint Medical | 2023-11-14 |
| QScout Lab; QScout RLD (K230878) | Ad Astra Diagnostics, Inc. | 2023-11-14 |
| Accu-Chek Safe-T-Pro Plus Lancing Device (K232488) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Accu-Chek Safe-T-Pro Uno Lancing Device (K232509) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (K232241) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| Cystoscope System (K231118) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 |
| BriefCase-Quantification (K232083) | Aidoc Medical , Ltd. | 2023-11-13 |
| Clarius Bladder AI (K232257) | Clarius Mobile Health Corp. | 2023-11-13 |
| Microwave Ablation System (BD-GT) (K232240) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831) | Depuy Ireland UC | 2023-11-13 |
| ELLAVI UBT (K230849) | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 |
| Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937) | Bionova Medical, Inc. | 2023-11-13 |
| Skin and Wound Cleanser (K231564) | Winner Medical Co., Ltd. | 2023-11-10 |
| Neuronaute Plus (K231366) | Bioserenity Sas | 2023-11-09 |
| TissueStat (K231277) | Durastat, LLC | 2023-11-09 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K223682) | Sirius Medical Systems B.V. | 2023-11-09 |
| SYMPHONY OCT System (K233366) | Medos International SARL | 2023-11-09 |
| ARK Hydrocodone Assay (K231752) | Ark Diagnostics, Inc. | 2023-11-09 |
| Flowflex COVID-19 Antigen Home Test (K230828) | ACON Laboratories, Inc. | 2023-11-09 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K231617) | Siemens Medical Solutions USA, Inc. | 2023-11-09 |
| BraveCX (K223754) | Bering, Ltd. | 2023-11-09 |
| Cardio P1 (K231150) | Bionet Co., Ltd. | 2023-11-09 |
| Flush Syringe (Prefilled 0.9% normal saline solution) (K231724) | Spm Medicare Pvt. , Ltd. | 2023-11-09 |
| Oxygen Concentrator (K230969) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023-11-09 |
| PRIME-XV FreezIS DMSO-Free MD (K231804) | Fujifilm Irvine Scientific | 2023-11-09 |
| Disposable Endoscope Injection Needles (K232442) | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 |
| Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810) | Micro-Nx Co., Ltd. | 2023-11-09 |
| Glenoid Reconstruction System – Full Wedge Baseplate (K231911) | Medacta International S.A. | 2023-11-09 |