| Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602) | Ga Health Company Limited | 2023-08-01 |
| Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (K230873) | Southern Implants (Pty), Ltd. | 2023-08-01 |
| Knotless Suture Anchor (K231278) | Riverpoint Medical, LLC | 2023-08-01 |
| Aristotle 18 Guidewire; Aristotle 24 Guidewire (K231954) | Scientia Vascular, Inc. | 2023-08-01 |
| Nuubo Smart (K231620) | Smart Solutions Technologies SL | 2023-08-01 |
| EXPD 4357; EXPD 4357P (K231959) | DRTECH Corporation | 2023-08-01 |
| BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System (K230956) | Bd Integrated Diagnostic Solutions / | 2023-07-31 |
| Disposable Hemoclip (K230004) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2023-07-31 |
| ZENEX Implant System_Narrow (K230630) | Izenimplant Co., Ltd. | 2023-07-31 |
| V-Print c&b temp (K231591) | Voco GmbH | 2023-07-31 |
| RenaNav Ureteroscope System (K223097) | CenterPoint Systems, LLC | 2023-07-31 |
| Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. (K231613) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2023-07-31 |
| Altris IMS (K232088) | Altris, Inc. | 2023-07-31 |
| Nooance Led And Laser Helmet (K231321) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-07-31 |
| CNS-2101 Central Monitor (K223567) | Nihon Kohden Corporation | 2023-07-31 |
| AllTest Fentanyl Rapid Test (Urine) (K231698) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 |
| QUATERA 700 (K230858) | Carl Zeiss Meditec, AG | 2023-07-31 |
| Surgical Sutures with or without Needle (K221767) | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 |
| SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC (K222862) | Lotuxs Medtech (Suzhou) Co., Ltd. | 2023-07-30 |
| SI-Cure Sacroiliac Joint Fusion System (K231951) | Alevio, LLC | 2023-07-28 |
| Therapy Mask 3100 NC/SP (K231313) | Respironics, Inc. | 2023-07-28 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K223710) | Abbott Point of Care, Inc. | 2023-07-28 |
| SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073) | Esthetic Medical, Inc. | 2023-07-28 |
| 3 Layer Surgical Mask (134252531) (K231618) | Original Mattress Factory, Inc. | 2023-07-28 |
| Bright MTA Sealer Plus (K231480) | Genoss Co., Ltd. | 2023-07-28 |
| Blood Tubing Lines for Hemodialysis AV06C-E (K231589) | NIKKISO CO., LTD. | 2023-07-28 |
| Pathfinder Endoscope Overtube with Balloon Device (K230801) | Neptune Medical, Inc. | 2023-07-28 |
| FlowStar Touch Digital Mixer Flowmeter (K222794) | Baldus Sedation GmbH & Co. KG | 2023-07-28 |
| MESI mTablet ECG Diagnostic System, MESI mTablet ECG (K223670) | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 |
| Electrocardiograph: SE-1200 Pro and SE-1201 Pro (K222902) | Edan Instruments, Inc. | 2023-07-28 |
| HJY VisualNext Endoscopic Vision System (K222735) | Hjy Smart Medical Device Co., Ltd. | 2023-07-28 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249) | Pentax of America, Inc. | 2023-07-28 |
| FLUOBEAM® LX Red (K230898) | Fluoptics Sas | 2023-07-28 |
| Dia-Cem (K231552) | DiaDent Group International | 2023-07-28 |
| BlueStar and BlueStar Rx (K230813) | Welldoc, Inc. | 2023-07-28 |
| Quantisal™ II Oral Fluid Collection Device (K223781) | Immunalysis Corporation | 2023-07-28 |
| PatCom Distal Chip Endoscope (K222587) | H&A Mui Enterprises, Inc. | 2023-07-28 |
| Adena-Zina Spinal System (K231931) | Shanghai Sanyou Medical Co, Ltd. | 2023-07-28 |
| SURGIVISIO Device (K231886) | Ecential Robotics | 2023-07-27 |
| Teleflex Rusch SoftSimplastic Foley Catheters (K212077) | Teleflexmedical, Inc. | 2023-07-27 |
| Therm-X (K231912) | Zenith Technical Innovations | 2023-07-27 |
| MDx-Chex for BC-GP (K231221) | Streck | 2023-07-27 |
| Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets (K230838) | Cardinal Health200, LLC | 2023-07-27 |
| Brainomix 360 Triage ICH (K231195) | Brainomix Limited | 2023-07-27 |
| cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (K223591) | Roche Molecular Systems, Inc. | 2023-07-27 |
| Altaviz Needle Kit II (K231261) | Altaviz, LLC | 2023-07-27 |
| Rapid Aneurysm Triage and Notification (K230074) | Ischemaview, Inc. | 2023-07-27 |
| R2P Navicross (K231044) | Terumo Medical Corporation | 2023-07-27 |
| MDx-Chex for BC-GN (K231223) | Streck | 2023-07-27 |
| LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (K231555) | iSMART Developments, Ltd. | 2023-07-27 |
| IBS-B MIS Beveled Screw System (K231236) | In2bones USA, LLC | 2023-07-27 |
| ApolloKnee (K231172) | Corin U.S.A. Limited | 2023-07-26 |
| DEPUY SYNTHES MAXFRAME AUTOSTRUT System (K231922) | DePuy Synthes | 2023-07-26 |
| ecoFIX® (K231787) | Science & Bio Materials (S.B.M.) Sas | 2023-07-26 |
| HS Fiber Cerclage (K220765) | Riverpoint Medical, LLC | 2023-07-26 |
| Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B (K222994) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-07-26 |
| CarboClear Cervical Cage System, CarboClear Cervical VBR System (K222874) | Carbofix Orthpedics , Ltd. | 2023-07-26 |
| uMI Panorama (K231572) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 |
| Global Hypoperfusion Index (GHI) Algorithm (K231038) | Edwards Lifesciences, LLC | 2023-07-26 |
| ME-APDS™; MAGENTIQ-COLO™ (K223473) | Magentiq Eye, Ltd. | 2023-07-25 |
| Patient Specific Planning Solution™ 3D Bone Models (K230540) | Biomet Manufacturing Corp | 2023-07-25 |
| Sonio Detect (K230365) | Sonio | 2023-07-25 |
| MOBILETT Impact (K231577) | Siemens Medical Solutions | 2023-07-25 |
| Enamel Coating Resin (K230455) | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 |
| DEKA ACE Pump System (K213536) | Deka Research and Development | 2023-07-25 |
| Reprocessed ViewFlex Xtra ICE Catheter (D087031) (K231621) | Stryker Sustainability Solutions | 2023-07-25 |
| Emit® II Plus Buprenorphine Assay (K221605) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| Apyx (K230730) | Escala Medical | 2023-07-25 |
| IDENTIFY (K230576) | Varian Medical Systems, Inc. | 2023-07-25 |
| ANDI (K230913) | Imeka Solutions, Inc. | 2023-07-25 |
| 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 (K231878) | STERIS Corporation | 2023-07-25 |
| EZ-IO Intraosseous Vascular Access System (K231924) | Teleflex Medical | 2023-07-25 |
| Exceed™ Biplanar Expandable Interbody System (K231275) | Spine Wave, Inc. | 2023-07-25 |
| A-TAP (previously called Arthrotap) (K231900) | Elcam Medical Acal | 2023-07-25 |
| Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl (K223752) | Central Medicare Sdn Bhd | 2023-07-24 |
| EsCom250 (K231523) | Spident Co., Ltd. | 2023-07-24 |
| Argus Cognitive ReVISION Software (K223322) | Argus Cognitive, Inc. | 2023-07-24 |
| Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333) | Kettenbach GmbH & Co. KG | 2023-07-24 |
| UltraSight AI Guidance (K223347) | Ultrasight, Inc. | 2023-07-24 |
| Atlan (K230931) | Drägerwerk AG Co. Kgaa | 2023-07-23 |
| Triever20 Curve (21-201) (K231848) | Inari Medical, Inc. | 2023-07-21 |
| Three Way Stop Cock (K223499) | M/S Romsons International | 2023-07-21 |
| EndoflipTM 300 System (K231861) | Covidien, LLC | 2023-07-21 |
| Irregular Rhythm Notification Feature (IRNF) (K231173) | Apple, Inc. | 2023-07-21 |
| 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (K231161) | Becton, Dickinson and Company | 2023-07-21 |
| Erchonia Violet ZERONA® Z6 OTC (K231474) | Erchonia Corporation | 2023-07-21 |
| Infrared Thermometer, Model: IR8807 (K223037) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-07-21 |
| NextAR™ Spine Platform (K223769) | Medacta International S.A. | 2023-07-21 |
| INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516) | Depuy Ireland UC | 2023-07-21 |
| MySpine Unilateral Guides (K231483) | Medacta International S.A. | 2023-07-21 |
| BD Alaris™ Pump Epidural Infusion Set (K221319) | Care Fusion | 2023-07-21 |
| Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316) | Conformis, Inc. | 2023-07-21 |
| Alkaline Phosphatase2 (K223317) | Abbott Ireland Diagnostics Division | 2023-07-21 |
| TruDi® Navigation System V3 (FG-2000-00) (K231862) | Acclarent, Inc. | 2023-07-21 |
| BD Alaris™ Pump Infusion Sets (K221327) | Care Fusion | 2023-07-21 |
| Firefighter™ NC Pro PTCA Balloon Catheter (K223189) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 |
| Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (K223288) | Brainlab AG | 2023-07-21 |
| Elecsys proBNP II, Elecsys proBNP II STAT (K223637) | Roche Diagnostics | 2023-07-21 |
| OptimMRI (K230150) | Rebrain, Sas | 2023-07-21 |