| Anthogyr Surgical Cassettes (K230680) | Anthogyr | 2023-07-11 |
| SPIRA® Posterior Lumbar Spacers (K230942) | Camber Spine Technologies | 2023-07-11 |
| MINIMA S System (K231925) | Lima Corporate S.P.A. | 2023-07-11 |
| NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (K231735) | Nu Vasive, Incorporated | 2023-07-11 |
| microINR System (K231711) | Iline Microsystems, S.L. | 2023-07-11 |
| EnteraLoc Flow (K223683) | Vonco Products | 2023-07-10 |
| Edge Upper Cervical System (K221307) | Spinal Simplicity, LLC | 2023-07-10 |
| Ziehm Vision RFD 3D (K231701) | Ziehm Imaging GmbH | 2023-07-10 |
| MOZI TPS (K223724) | Manteia Technologies Co., Ltd. | 2023-07-10 |
| PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID (K231312) | Biosense Webster, Inc. | 2023-07-10 |
| Play&Joy InvisiLube Lubricant Capsule (K220646) | Innovemed Bio-Tech Co., Ltd. | 2023-07-10 |
| AcQMap High Resolution Imaging and Mapping System (K231091) | Acutus Medical, Inc. | 2023-07-10 |
| CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (K231412) | Biosense Webster, Inc. | 2023-07-10 |
| X-View 3D Pan/X-View 2D Pan (K222666) | Trident S.R.L | 2023-07-10 |
| Tandem Mobi Insulin Pump with Interoperable Technology (K223213) | Tandem Diabetes Care, Inc. | 2023-07-10 |
| Endofill (K231387) | Lumendo AG | 2023-07-10 |
| T3 Platform software (K223578) | Etiometry, Inc. | 2023-07-07 |
| Cleo (K232011) | American Orthodontics | 2023-07-07 |
| Invia® Integrated Dressing (K223388) | Medela AG | 2023-07-07 |
| Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) (K231318) | Beijing Adss Development Co., Ltd. | 2023-07-07 |
| ANDORATE® Valve Kit (K230932) | Ga Health Company Limited | 2023-07-07 |
| Spine CAMP™ (1.1) (K231668) | Medical Metrics, Inc. | 2023-07-07 |
| BT-001 (DEN220058) | Better Therapeutics | 2023-07-07 |
| Bladder Scanner Model: BVT02 (K223448) | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 |
| AeviceMD (K223382) | Aevice Health Pte. , Ltd. | 2023-07-07 |
| Overture Orthopaedics Patellofemoral System (K231253) | Overture Resurfacing, Inc. | 2023-07-07 |
| ProMIS™ Fixation System (K231844) | Premia Spine, Ltd. | 2023-07-07 |
| Complement Kit Cases (K230804) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-07-07 |
| Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood (K230080) | Yangzhou Medline Industry, Co., Ltd. | 2023-07-07 |
| IH Implant System (K222707) | Sewonmedix, Inc. | 2023-07-07 |
| Lumos 3DX (K223780) | 3Dio | 2023-07-06 |
| ARGUS PB-3000 (K221056) | Schiller AG | 2023-07-06 |
| MyEllevate (K230510) | Cynosure, LLC | 2023-07-06 |
| VYBE RF Electrosurgical System (K230968) | ShenB Co., Ltd. | 2023-07-06 |
| Servo-air Lite Ventilator System (K230173) | Maquet Critical Care AB | 2023-07-06 |
| VERTICALE® Triangular Fixation System (K223806) | Silony Medical GmbH | 2023-07-06 |
| SpinMedix Absorbable Fibrous Membrane (K222220) | Celestray Biotech Company, LLC., | 2023-07-06 |
| Tyber Medical Pin and Wire System (various) (K231339) | Tyber Medical, LLC | 2023-07-06 |
| HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (K231568) | Hardy Diagnostics | 2023-07-06 |
| Whitsundays Mask System (K223747) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 |
| Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) (K231003) | Guangdong Optomedic Technologies, Inc. | 2023-07-06 |
| Universal Seal (5-12 mm) (K231358) | Intuitive Surgical, Inc. | 2023-07-05 |
| Rotium Bioresorbable Wick (K231641) | Nanofiber Solutions, LLC | 2023-07-05 |
| Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm (K231279) | Ablative Solutions, Inc. | 2023-07-05 |
| Tissue Approximation System (TAS) (K220980) | Tas Medical, Inc. | 2023-07-05 |
| Integral Titanium Cervical Interbody (K222015) | Nvision Biomedical Technologies, Inc. | 2023-07-05 |
| LungTrainer (MD2 & MD3) (K221058) | Lung Trainers, LLC | 2023-07-05 |
| VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864) | bioMerieux, Inc. | 2023-07-05 |
| Electric Scooter (Model: M2020) (K230001) | Guangdong Prestige Technology Co., Ltd. | 2023-07-05 |
| MemorialTM Gloves (K231740) | Us Glove Supply | 2023-07-04 |
| Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) (K230569) | Cardinalhealth | 2023-07-03 |
| IVYLASER Handhold Hair Removal Machine (K230025) | Ivylaser (Beijing) Technology Co.,Ltd | 2023-07-03 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| Axial3D Insight (K222745) | Axial Medical Printing Limited | 2023-07-03 |
| BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (K231653) | Thrombolex, Inc. | 2023-07-03 |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (K231280) | CarboFix Orthopedics , Ltd. | 2023-07-03 |
| Dental Lithium Disilicate Glass-Ceramic (K230487) | Fuzhou Rick Brown Biomaterials Co., Ltd. | 2023-07-03 |
| CLEARinse CTS Specimen Collection and Transport System (K221664) | Aardvark Medical, Inc. | 2023-07-03 |
| LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (K230720) | Light Tree Ventures Europe B.V. | 2023-07-03 |
| NB Implant System (K230725) | Arum Dentistry Co., Ltd. | 2023-07-01 |
| REMI Remote EEG Monitoring System (K230933) | Epitel, Inc. | 2023-06-30 |
| 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter (K230156) | Medtronic Vascular | 2023-06-30 |
| Ulspira TS Nitric Oxide Therapy System (K212409) | Airgas Therapeutics | 2023-06-30 |
| preCARDIA Occlusion System (K221294) | Abiomed, Inc. | 2023-06-30 |
| iFuse TORQ® Implant System (K231689) | SI-BONE, Inc. | 2023-06-30 |
| IOB Temperature Management System (K231596) | Iob Medical, Inc. | 2023-06-30 |
| Inogen Rove 6 (K230052) | Inogen, Inc. | 2023-06-30 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) (K230935) | Thermo Fisher Scientific | 2023-06-30 |
| enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930) | STERIS Corporation | 2023-06-30 |
| Blood Pressure Monitor (K223374) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-06-30 |
| AblatePal Radiofrequency Ablation System (K223135) | Compal Electronics, Inc. | 2023-06-30 |
| SGM Femoral Nail System (K230456) | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-06-30 |
| ClearTip (K231267) | Finemedix Co., Ltd. | 2023-06-30 |
| Vantage PSI System (K231585) | 3D Systems, Inc. | 2023-06-30 |
| Pixyl.Neuro (K213253) | Pixyl SA | 2023-06-30 |
| Unistik® ShieldLock, Unistik VacuFlip (K223854) | Owen Mumford, Ltd. | 2023-06-30 |
| PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K230991) | Given Imaging Ltd. (Medtronic) | 2023-06-30 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K231588) | ABBOTT MEDICAL | 2023-06-30 |
| AirTom (K222466) | Bilab | 2023-06-30 |
| Ventana™ L Spinal System (K231252) | Spinal Elements, Inc. | 2023-06-30 |
| Easy On Universal Glaze & Stain (K231264) | Doctus Global | 2023-06-30 |
| FebriDx Bacterial / Non-bacterial Point of Care Assay (K230917) | Lumos Diagnostics, Inc. | 2023-06-30 |
| Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (K223694) | Duearity AB | 2023-06-30 |
| MeMed BV (K230944) | MeMed Diagnostics, Ltd. | 2023-06-30 |
| Compact Wearable Pump (K230469) | Lansinoh Laboratories | 2023-06-30 |
| EarliPoint (K230337) | Earlitec Diagnostics, Inc. | 2023-06-29 |
| OverStitch NXT Endoscopic Suturing System (K231553) | Apollo Endosurgery, Inc. | 2023-06-29 |
| KidneyIntelX.dkd (DEN200052) | Renalytix Ai, Inc. | 2023-06-29 |
| Phantom XL Insulated Dilators (K231691) | TeDan Surgical Innovations, Inc. | 2023-06-29 |
| NeuroSwift Pro (K223047) | Neurobit Technologies Co., Ltd. | 2023-06-29 |
| F&P 950 Accessory Breathing Circuit Kits (K221436) | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 |
| MYAH (K222933) | Visia Imaging S.R.L. | 2023-06-29 |
| OsteoCentric ACL Fixation System (K230595) | OsteoCentric Technologies | 2023-06-29 |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K231549) | Boston Scientific Corporation | 2023-06-29 |
| Flume Catheter (K231101) | Flume Catheter Company, Ltd. | 2023-06-29 |
| Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) (K230374) | Dongguan TT Medical, Inc. | 2023-06-29 |
| Upper Arm Blood Pressure Monitor (K230176) | Shenzhen Yolanda Technology Co., Ltd. | 2023-06-29 |
| SQ.line KERRISON (K223596) | Aesculap, Inc. | 2023-06-29 |
| HotDog Warming Mattress + Return Electrode (K230866) | Augustine Temperature Management, LLC | 2023-06-29 |
| XENOVIEW 3.0T Chest Coil (K231647) | Polarean, Inc. | 2023-06-29 |