| Little Wave Arc; Little Wave Flip (K223533) | Ki Mobility, LLC | 2023-08-31 |
| EL27-Compact; Sterile EHL-Probes (K230488) | Walz Elektronik GmbH | 2023-08-31 |
| The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL (K231433) | Thermo Fisher Scientific | 2023-08-31 |
| Little Wave Clik, Rogue XP, Little Wave XP, Spark (K223527) | Ki Mobility, LLC | 2023-08-31 |
| BD Kiestra IdentifA (K222563) | Becton, Dickinson and Company | 2023-08-31 |
| OSPREY Closed IV Catheter System (OspreyV2) (K231626) | Skydance Vascular, Inc. | 2023-08-31 |
| Q21 (K221959) | Neurofield, Inc. | 2023-08-31 |
| ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (K231616) | Zeus Scientific | 2023-08-31 |
| HOLO Portal™ Surgical Guidance System (K231611) | Surgalign Spine Technologies | 2023-08-31 |
| Spinery™ RF Ablation System (K223303) | Axon Spine Medical System | 2023-08-30 |
| NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580) | Medtronic Xomed, Inc. | 2023-08-30 |
| Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) (K231123) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | 2023-08-30 |
| LAA Exclusion System (K232295) | Syntheon, LLC | 2023-08-30 |
| AlphaVent Suture Anchors (K231093) | Stryker Endoscopy | 2023-08-30 |
| AquaBeam Robotic System (K231024) | Procept Biorobotics, Corporation | 2023-08-30 |
| Mick Valencia Applicator Set (K230155) | Mick Radio-Nuclear Instruments, Inc. | 2023-08-30 |
| Brainomix 360 e-MRI (K231656) | Brainomix Limited | 2023-08-30 |
| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| AC3™ Series IABP (K232343) | Arrow International, LLC | 2023-08-30 |
| Enzyme Packed Cartridge - RELiZORB (K231156) | Alcresta Therapeutics, Inc. | 2023-08-30 |
| NIBPCuff (K231961) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 |
| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418) | Orthocon, Inc. | 2023-08-30 |
| Silk'n Titan Allways (K230013) | Silk'N Beauty , Ltd. | 2023-08-30 |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355) | Canon Medical Systems Corporation | 2023-08-30 |
| Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) (K230603) | Teleflex Medical | 2023-08-30 |
| S-Patch Ex Wearable ECG Patch (K231289) | Wellysis Corp. | 2023-08-30 |
| Ventrax™ Delivery System (VTR851) (K231246) | Merit Medical Systems, Inc. | 2023-08-30 |
| Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml (K231988) | Thermo Fisher Scientific | 2023-08-30 |
| Nexis® compressive screws (K223468) | Novastep | 2023-08-30 |
| Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) (K223130) | Covidien | 2023-08-30 |
| StealthFix Intraosseous Fixation System (K232324) | Medartis, Inc. | 2023-08-30 |
| Ochsner Connected Inhaler Sensor (K223367) | Ochsner Clinic Foundation | 2023-08-30 |
| LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313) | Ethicon Endo Surgery, LLC | 2023-08-29 |
| Precice Ankle Salvage System (K230765) | Nuvasive Specialized Orthopedics, Inc. | 2023-08-29 |
| ARROW Off-Centred Humeral Insert (K232226) | FH Industrie | 2023-08-29 |
| circul™ pro Ring (K221361) | Bodimetrics, LLC | 2023-08-29 |
| StarFin (K231407) | Premium Medical Technology, LLC | 2023-08-29 |
| Distal Elbow Plating System (K231623) | Skeletal Dynamics, Inc. | 2023-08-28 |
| CALLISTO eye (K231676) | Carl Zeiss Meditec, AG | 2023-08-28 |
| Alveoair Digital Spirometer (K222525) | Roundworks Technologies Private Limited | 2023-08-28 |
| SofWave System (K231537) | Sofwave Medical, Ltd. | 2023-08-28 |
| Treace Medical Concepts (TMC) Compression Implant System (K232387) | Treace Medical Concepts | 2023-08-28 |
| VisAble.IO (K223639) | Techsomed | 2023-08-28 |
| SoundBite® Crossing System XS Peripheral (K230159) | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K231435) | Kimberly-Clark Corporation | 2023-08-28 |
| Precision GI (K231422) | Limaca Medical, Ltd. | 2023-08-28 |
| QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (K230221) | Versant Medical Physics and Radiation Safety | 2023-08-28 |
| Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) (K230165) | Coloplast | 2023-08-25 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (K230566) | Joytech Healthcare Co. , Ltd. | 2023-08-25 |
| BioProtect Balloon Implant™ System (K222972) | Bioprotect, Ltd. | 2023-08-25 |
| BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (K213670) | Becton, Dickinson and Company | 2023-08-25 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| Montage-QS Settable, Resorbable Bone Putty (K231903) | Orthocon, Inc. | 2023-08-25 |
| Wrist Type Blood Pressure Monitor (W05,W1101L) (K230409) | Shenzhen Jamr Technology Co., Ltd. | 2023-08-25 |
| VitalFlowTM Centrifugal Pump (K223898) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| Lavieen (K223727) | Wontech Co., Ltd. | 2023-08-25 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL (K231994) | Thermo Fisher Scientific | 2023-08-25 |
| MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014) | Tonica Elektronik A/S | 2023-08-25 |
| Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (K230094) | Responsive Arthroscopy, LLC | 2023-08-25 |
| 072 Aspiration System (K222786) | Q'Apel Medical, Inc. | 2023-08-25 |
| Sterilization Wrap (K223600) | Wuhan Zonsen Medical Products Co., Ltd. | 2023-08-25 |
| Non absorbable Surgical Polyester Suture (K231183) | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) (K231872) | Kirwan Surgical Products, LLC | 2023-08-25 |
| NovoFine® Plus (K231255) | Novo Nordisk, Inc. | 2023-08-25 |
| Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (K230928) | Vein 360, LLC | 2023-08-25 |
| OMNI Surgical System (K232214) | Sight Sciences, Inc. | 2023-08-25 |
| Reusable Temperature Probe, Disposable Temperature Probe (K223807) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 |
| AIRAscore (K223180) | Airamed GmbH | 2023-08-25 |
| AccelFix Lumbar Expandable Cage System (K231680) | L&K BIOMED Co., Ltd. | 2023-08-24 |
| Instrument Case (K231604) | Cochlear Americas | 2023-08-24 |
| Nitrile Patient Examination Gloves, Powder Free, Pink Color (K222103) | Shandong Yinghng Medical Products Co., Ltd. | 2023-08-24 |
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) | Kronus, Inc. | 2023-08-24 |
| Quantra Hemostasis Analyzer (K232215) | Hemosonics, LLC | 2023-08-24 |
| Essenz HLM, Essenz ILBM (K232291) | Livanova Deutschland, GmbH | 2023-08-24 |
| Plum Duo™ Infusion System (K223607) | Icu Medical, Inc. | 2023-08-24 |
| Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599) | Stryker Leibinger GmbH & Co KG | 2023-08-24 |
| ZENEX FreeMilling & CCM Cast Abutment (K231557) | Izenimplant Co., Ltd. | 2023-08-24 |
| CATAMARAN SI Joint Fusion System (K231944) | Tenon Medical, Inc. | 2023-08-24 |
| Monaghan medical filtered mouthpiece kit (K220145) | Monaghan Medical Corporation | 2023-08-24 |
| Zenius™ Spinal System (K232218) | Medyssey USA, Inc. | 2023-08-24 |
| Arthrex Radiopaque FiberTape Cerclage sutures (K230976) | Arthrex, Inc. | 2023-08-24 |
| Natural Cycles (K231274) | Natural Cycles Nordic AB | 2023-08-24 |
| Current Health System (K231506) | Current Health , Ltd. | 2023-08-24 |
| APS Metal Plate & Screw System (K223150) | A Plus Biotechnology Co., Ltd. | 2023-08-24 |
| LifeShield™ Infusion Safety Software Suite (K223606) | Icu Medical, Inc. | 2023-08-24 |
| Maxiocel Chitosan Wound Dressing (K212766) | Advamedica, Inc. | 2023-08-24 |
| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
| Withings Scan Monitor 2.0 (K230812) | Withings | 2023-08-23 |
| Oneday Mini Implant System (K222946) | Oneday Biotech Co., Ltd. | 2023-08-23 |
| Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) (K230610) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |
| EVO 700 series high speed handpiece (K232243) | Ttbio Corp. | 2023-08-23 |
| Access Folate Assay (K223590) | Beckman Coulter, Inc. | 2023-08-23 |
| Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (K230079) | Ansell Healthcare Products, LLC | 2023-08-23 |
| Nova HD+ (K220938) | Aura Wellness, LLC | 2023-08-22 |
| Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (K231510) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 |
| IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) (K223574) | Philips Medizin Systeme Boeblingen GmbH | 2023-08-22 |
| Zavation Connector System (K231811) | Zavation Medical Products, LLC | 2023-08-22 |
| BrachyGel Vaginal Hydrogel Packing System (DEN220052) | Brachyfoam, Inc. D/B/A Advaray | 2023-08-22 |
| qXR-PTX-PE (K230899) | Qure.Ai Technologies | 2023-08-22 |
| GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (K231205) | Gurunanda, LLC | 2023-08-22 |