| EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (K240879) | Endogastric Solutions, Inc. | 2024-04-26 |
| ASTar BC G- Kit and ASTar Instrument (K221688) | Q-Linea AB | 2024-04-26 |
| BioStar Single Use Transbronchial Aspiration Needle (K232038) | Broncus Medical, Inc. | 2024-04-26 |
| Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) (K240299) | Zimmer, Inc. | 2024-04-26 |
| Temporis, Irix Plus (K231142) | Dws S.R.L. | 2024-04-25 |
| Portrait VSM (K233810) | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (K240846) | CarboFix Orthopedics , Ltd. | 2024-04-25 |
| Digital ClarusScope System; Digital NeuroPEN System (K240535) | Clarus Medical, LLC | 2024-04-25 |
| Dental Cone-beam Computed Tomography (K240855) | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 |
| Copan Universal Transport Medium (UTM-RT) System (K232357) | Copan Italia Spa | 2024-04-25 |
| InVision Precision LVEF (LVEF) (K232331) | InVision Medical Technology Corporation | 2024-04-25 |
| Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (K233308) | Nakanishi, Inc. | 2024-04-25 |
| 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (K232246) | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 |
| ENDOFIX EXO (K232405) | Aktormed GmbH | 2024-04-25 |
| CDI OneView Monitoring System (K234065) | Terumo Cardiovascular Systems Corporation | 2024-04-25 |
| Kronos Electrocautery Device (K232805) | Single Pass, Inc. | 2024-04-25 |
| LUOFUCON® Collagen Particles (Collagen Wound Dressing) (K232796) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-04-25 |
| OpenRad Cloud (K240839) | Openrad Services Uk, Ltd. | 2024-04-24 |
| Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) (K232181) | Hebei JT Medical Co., Ltd. | 2024-04-24 |
| Omnia Medical TiBrid™-SA System (K240623) | Omnia Medical, LLC | 2024-04-24 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K240850) | Philips Ultrasound, LLC | 2024-04-24 |
| 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads (K234025) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-24 |
| DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) (K240319) | Pro Med Instruments GmbH | 2024-04-24 |
| Image Management V15 (K240822) | Philips Medical Systems Technologies | 2024-04-24 |
| NextAR™ Spine Platform (K233172) | Medacta International S.A. | 2024-04-24 |
| SSS-NX (Serum Substitute Supplement-NX) (K233764) | Fujifilm Irvine Scientific | 2024-04-24 |
| IPL Home Use Hair Removal Device (SJ15) (K240093) | Shenzhen Shuge Medical Beauty Devices Co., Ltd. | 2024-04-24 |
| DESS Dental Smart Solutions (K240208) | Terrats Medical SL | 2024-04-24 |
| canturio® se (Canturio Smart Extension) (K234056) | Canary Medical USA, LLC | 2024-04-24 |
| Provisio™ SLT IVUS™ System (K233948) | Provisio Medical, Inc. | 2024-04-23 |
| MeDioStar (K240816) | Asclepion Laser Technologies GmbH | 2024-04-23 |
| mJOULE RF System and Accessories (K222958) | Sciton, Inc | 2024-04-23 |
| Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (K234107) | Laborie Medical Technologies, Corp. | 2024-04-23 |
| Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set (K233329) | Route 92 Medical, Inc. | 2024-04-23 |
| QUANTUM® Patient Specific Instrumentation (PSI) System (K231699) | In2bones Sas | 2024-04-23 |
| BTL-499 (K233849) | BTL Industries, Inc. | 2024-04-23 |
| AEYE-DS (K240058) | Aeye Health, Inc. | 2024-04-23 |
| Dexcom G7 Continuous Glucose Monitoring System (K240902) | Dexcom, Inc. | 2024-04-23 |
| ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) (K234147) | Microline Surgical, Inc. | 2024-04-23 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K233537) | Abbott Diabetes Care, Inc. | 2024-04-23 |
| swiftPro™ System (K240518) | Emblation Limited | 2024-04-23 |
| Black Pearl Nitrile Examination Glove (K232319) | Ug Global Resources Sdn. Bhd. | 2024-04-22 |
| Access EPO (K240182) | Beckman Coulter, Inc. | 2024-04-22 |
| Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System (K240115) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-04-22 |
| Rapid (K233582) | Ischemaview, Inc. | 2024-04-22 |
| Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (K234041) | Andon Health Co, Ltd. | 2024-04-22 |
| ART-Plan (v.2.2.0) (K234068) | Therapanacea Sas | 2024-04-22 |
| Anterior Spine Truss System-Stand Alone (ASTS-SA) (K233966) | 4Web Medical, Inc. | 2024-04-22 |
| Acumed Wrist Plating System (K233311) | Acumed, LLC | 2024-04-22 |
| MamaLift Plus (K223515) | Curio Digital Therapeutics, Inc. | 2024-04-22 |
| BowTie™ SI Joint Fusion System (K232149) | Sail Fusion, LLC | 2024-04-20 |
| KeYi Total Knee System (K230120) | Beijing Keyi Medical Device Technology Co., Ltd. | 2024-04-19 |
| Patriot-SI Posterior Implant System (K232259) | Spinal Simplicity, LLC | 2024-04-19 |
| Patient Monitor (iX10, iX12, iX15) (K232962) | Edan Instruments, Inc. | 2024-04-19 |
| AccuCath Ace™ Intravascular Catheter (K233106) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024-04-19 |
| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K233737) | Ulrich GmbH & Co. KG | 2024-04-19 |
| APTUS Foot System 2.8-3.5 (K232105) | Medartis AG | 2024-04-19 |
| SafeOp 3: Neural Informatix Systeem (K234092) | Alphatec Spine, Inc. | 2024-04-19 |
| FAQ™ 201, FAQ™ 202 (K240378) | Foreo, Inc. | 2024-04-19 |
| Electrical Neuromuscular Stimulator, Cure Trio (K233046) | Oriental Inspiration Limited | 2024-04-19 |
| Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (K240508) | Laclede, Inc. | 2024-04-19 |
| Healgen Rapid COVID-19 Antigen Test (K232377) | Healgen Scientific,, LLC | 2024-04-19 |
| SKOUT® system (K240781) | Iterative Scopes, Inc. | 2024-04-19 |
| LIFEPAK® 35 AC Power Adapter (41335-000001) (K240162) | Stryker Physio-Control | 2024-04-19 |
| ICE Aspiration System (K234073) | Expanse Medical, Inc. | 2024-04-19 |
| Flowflex® Plus COVID-19 Home Test (K233373) | ACON Laboratories, Inc. | 2024-04-19 |
| UniSpace® Stand-Alone C Cage (K234119) | Innosys Co., Ltd. | 2024-04-19 |
| ReyaGel (RG03 - MTP gel 3mL) (K232204) | Fettech | 2024-04-19 |
| NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System (K232566) | SeaSpine Orthopedics Corporation | 2024-04-19 |
| Bio-Medicus Life Support Catheter and Introducer (K240534) | Medtronic, Inc. | 2024-04-19 |
| Hemoblock_S (Prescription); Hemoblock_S (OTC) (K232216) | Incore Co., Ltd. | 2024-04-19 |
| Miro3D Fibers Wound Matrix (K240753) | Reprise Biomedical, Inc. | 2024-04-19 |
| Prospera Spectruum Negative Pressure Wound Therapy System (K230233) | Deroyal Industries, Inc. | 2024-04-18 |
| Ethylene Oxide Sterilization Supplier Change for MPO Hips (K240046) | Microport Orthopedics | 2024-04-18 |
| HotDog Warming Mattress + Return Electrode (K232627) | Augustine Temperature Management, LLC | 2024-04-18 |
| RAYSCAN a-Expert (K232325) | Ray Co., Ltd. | 2024-04-18 |
| EMBOGUARD Balloon Guide Catheter (K233924) | Neuravi Limited | 2024-04-18 |
| Disposable Medical Face Mask (M643BE) (K240258) | Makrite Industries, Inc. | 2024-04-18 |
| Cochlear Osia System (K240155) | Cochlear Americas | 2024-04-18 |
| Difiney Anti Snoring Device (K233850) | Fissiontech, LLC | 2024-04-18 |
| zLOCK Lumbar Facet Fixation System (K240085) | Zygofix , Ltd. | 2024-04-18 |
| Mobility Scooter (C4+) (K234098) | Yongkang Yile Vehicle Co., Ltd. | 2024-04-18 |
| Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens (K240519) | Innova Vision, Inc. | 2024-04-17 |
| Enteral Feeding Sets (K240039) | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
| MSFX Mikron Cervical Anterior Plate System (K240484) | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 |
| Goyo Mouthpiece S (K232238) | Dimedikorea | 2024-04-17 |
| Carilex VT¿200-i NX (K231646) | Carilex Medical, Inc. | 2024-04-17 |
| TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- (K233863) | TriMed, Inc. | 2024-04-17 |
| Celerity Chemical Indicator for enspire 3000 CLCSPS (K240032) | STERIS Corporation | 2024-04-17 |
| TraumaGuard Intra-abdominal Pressure Sensing System (K240057) | Sentinel Medical Technologies, LLC | 2024-04-17 |
| uOmnispace.MR (K233186) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-17 |
| Sectra Digital Pathology Module (Version 3.3) (K232208) | Sectra AB | 2024-04-16 |
| Aperio GT 450 DX (K232202) | Leica Biosystems Imaging, Inc. | 2024-04-16 |
| Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (K233886) | Ambu A/S | 2024-04-16 |
| ReBorn (1050nm) (K233962) | Lightfective , Ltd. | 2024-04-16 |
| Alcantara Thoracolumbar Plate System (K232256) | Camber Spine Technologies, LLC | 2024-04-16 |
| Co2 Laser System, Models: PureLase And VanLase (K232133) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2024-04-16 |
| nextaro® v, 20/20 (K240748) | Sfm Medical Devices GmbH | 2024-04-16 |
| Ez Catch Auto; Ez Catch YR; Ez Catch TR (K240205) | Veol Medical Technologies Pvt , Ltd. | 2024-04-15 |
| VisAble.IO (K240773) | Techsomed | 2024-04-15 |