| Sepsis ImmunoScore (DEN230036) | Prenosis, Inc. | 2024-04-02 |
| Calibra Abutment Resin Cement (K240888) | Dentsply Sirona | 2024-04-02 |
| ECG-less Cardiac (K233750) | Ge Medical Systems, LLC | 2024-04-02 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (K211815) | Affinity Biosensors | 2024-04-02 |
| Zoom 6F Insert Catheters (K233975) | Imperative Care, Inc. | 2024-04-02 |
| Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (K232835) | Canon Medical Systems Corporation | 2024-04-02 |
| ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm (K240635) | Ximedica | 2024-04-01 |
| Us2.v2 (K233676) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2024-04-01 |
| Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) (K233990) | Shandong Xingyu Gloves Co., Ltd. | 2024-04-01 |
| EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043) | Microport Orthopedics, Inc. | 2024-04-01 |
| Talis EMR with Talis +ACG (Talis EMR with +ACG) (K233133) | Talis Clinical, LLC | 2024-04-01 |
| CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, (K230895) | Cefla S.C. | 2024-04-01 |
| SF Push- in Anchor (K240288) | Surgical Fusion Technologies GmbH | 2024-04-01 |
| External Hex Implant System (K232726) | Southern Implants (Pty), Ltd. | 2024-04-01 |
| MagnetOs Putty (K240442) | Kuros Biosciences B.V | 2024-04-01 |
| AlphaVac MMA F1885 System (H787253020) (K240397) | AngioDynamics, Inc. | 2024-04-01 |
| Rejoyn (K231209) | Otsuka America Pharmaceutical, Inc. | 2024-03-30 |
| Disposable Surgical Gown (K233068) | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| AlignRT Plus (K233622) | Vision Rt, Ltd. | 2024-03-29 |
| Novum IQ Large Volume Pump (K211122) | Baxter Healthcare Corporation | 2024-03-29 |
| LUNA 3D (K232031) | Lap GmbH Laser Applikationen | 2024-03-29 |
| AVIEW CAC (K233211) | Coreline Soft Co., Ltd. | 2024-03-29 |
| Citrated: K, KH, RTH, FFH (K232018) | Haemonetics Corporation | 2024-03-29 |
| Dose IQ Safety Software (K230665) | Baxter Healthcare Corporation | 2024-03-29 |
| Disposable Sphincterotome (K232825) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 |
| Genesys Spine Sacroiliac Joint Fusion System with Navigation (K233595) | Genesys Spine | 2024-03-29 |
| MAGNETOM Viato.Mobile (K240608) | Siemens Medical Solutions USA, Inc. | 2024-03-29 |
| SmoothSkin Pure Unplugged (SSB3) (K240587) | Cyden Limited | 2024-03-29 |
| LCD Monitors C310S, G310S, C316S, G316S, C616W (K240310) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-03-29 |
| LINQ II™ Insertable Cardiac Monitor (ICM) (K240693) | Medtronic, Inc. | 2024-03-28 |
| IS-III active Short Implant (K232049) | Neobiotech Co., Ltd. | 2024-03-28 |
| Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K232079) | Wrp Asia Pacific Sdn. Bhd. | 2024-03-28 |
| VIVACE (K232047) | Unimom.Co | 2024-03-28 |
| Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (K232013) | Goodman Co., Ltd. | 2024-03-28 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| FDR Visionary Suite (K233719) | Shimadzu Corporation | 2024-03-28 |
| InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) (K240295) | Instanosis, Inc. | 2024-03-28 |
| Eko Low Ejection Fraction Tool (ELEFT) (K233409) | Eko Health, Inc. | 2024-03-28 |
| CORE 500 Digital Stethoscope (K233609) | Eko Health, Inc. | 2024-03-28 |
| BTL-785S (K233604) | BTL Industries, Inc. | 2024-03-28 |
| Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) (K233838) | Medtronic, Inc. | 2024-03-28 |
| CustomizedBone Service (K240567) | Fin-Ceramica Faenza S.P.A. | 2024-03-28 |
| Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) (K240284) | Shenzhen Browiner Tech Co., Ltd. | 2024-03-28 |
| NAEOTOM Alpha (K233657) | Siemens Medical Solutions USA, Inc. | 2024-03-28 |
| OEC 3D (K233669) | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (K233909) | Argon Medical Devices, Inc. | 2024-03-28 |
| ProSeal™ Injector Plus (Model no. 421050) (K240171) | Epic Medical Pte. , Ltd. | 2024-03-28 |
| CARPL (CARPL) (K232891) | Carpl Ai, Inc. | 2024-03-27 |
| Medline ART Skin Harvesting System (DEN210049) | Medline Industries, Inc. | 2024-03-27 |
| LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (K223360) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-03-27 |
| ARX Liquid Amies Collection & Transport System (K222613) | Arx Sciences, Inc. | 2024-03-27 |
| MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) (K233201) | Penumbra, Inc. | 2024-03-27 |
| CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (K233951) | Medtronic Sofamor Danek USA, Inc. | 2024-03-27 |
| CarboClear® Posterior Cervical Screw System (K233989) | CarboFix Orthopedics , Ltd. | 2024-03-27 |
| i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) | Abbott Point of Care | 2024-03-27 |
| Modius Stress (K232253) | Neurovalens Limited | 2024-03-27 |
| Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (K231425) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024-03-27 |
| Lucent® XP (K234150) | Spinal Elements | 2024-03-27 |
| QStat Cartridge (K240045) | Hemosonics, LLC | 2024-03-27 |
| Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K234097) | Ever Growth (Vietnam) Corporation Limited | 2024-03-27 |
| Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) (K240389) | Hyundae Meditech Co., Ltd. | 2024-03-27 |
| MAMMOMAT B.brilliant (K233539) | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (K233611) | Maine Molecular Quality Controls, Inc. | 2024-03-26 |
| PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (K233151) | Medline Industries, LP | 2024-03-26 |
| SyMRI (K233733) | Syntheticmr AB (Publ.) | 2024-03-26 |
| Removal System Large Bore 60 cc Syringe (K233069) | Inari Medical, Inc. | 2024-03-26 |
| J & P Click Attachments (K231132) | J & P Dental Technologies | 2024-03-26 |
| SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed (K233650) | Siemens Medical Solutions USA, Inc. | 2024-03-26 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (K232954) | Biofire Diagnostics, LLC | 2024-03-26 |
| Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) (K231984) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2024-03-26 |
| Grappler Suture Anchor R3FLEX IOL System (K240594) | Paragon 28, Inc. | 2024-03-26 |
| RODIN 3D Resin SPLINT, Hard/Flex (K231793) | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| Micropuncture Introducer Sets; Micropuncture Pedal Access Sets (K240589) | Cook Medical | 2024-03-25 |
| LW Implant System – Abutment (K233167) | Ossvis Co., Ltd. | 2024-03-25 |
| RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) (K233275) | Gyrus Acmi, Inc. | 2024-03-25 |
| Transcutaneous Electrical Nerve Stimulator (9029SCM) (K240292) | Hong Kong Etech Groups Limited | 2024-03-25 |
| Modus IR (K231986) | Synaptive Medical, Inc. | 2024-03-25 |
| Cube Navigator (K240620) | Medical Templates AG | 2024-03-25 |
| STERI-OSS Implant System (K232268) | Zeros Co., Ltd. | 2024-03-25 |
| VariAx 2 Distal Radius System (K233919) | Stryker GmbH | 2024-03-25 |
| Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F) (K240329) | Yongkang Youha Electric Appliance Co., Ltd. | 2024-03-25 |
| MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080) | Soterix Medical, Inc. | 2024-03-25 |
| LUNE™ PureHygiene (K234085) | Enamel Pure | 2024-03-25 |
| Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) (K231953) | Coloplast Corp. | 2024-03-22 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (K232354) | Murata Vios, Inc. | 2024-03-22 |
| NeuroStar Advanced Therapy System (All previously cleared models) (K231926) | Neuronetics, Inc. | 2024-03-22 |
| Augment Off-Axis Instrument System (K233148) | Fix Surgical | 2024-03-22 |
| RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (K232920) | Ureteral Stent Company | 2024-03-22 |
| aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device (K232282) | Carlsmed, Inc. | 2024-03-22 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K240225) | Shockwave Medical, Inc. | 2024-03-22 |
| MAGNETOM Terra; MAGNETOM Terra.X (K232322) | Siemens Medical Solutions USA, Inc. | 2024-03-22 |
| Esophageal TTS Stent (K240522) | Taewoong Medical | 2024-03-22 |
| Corsano CardioWatch 287-2 System (K232548) | Corsano Health B.V. | 2024-03-22 |
| QuickVue COVID-19 Test (K231795) | Quidel Corporation | 2024-03-22 |
| Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (K231806) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 |
| Idys® C ZP 3DTi (K240715) | Clariance | 2024-03-22 |
| Pilling Tracheostomy Tubes (K233713) | Teleflex Medical | 2024-03-22 |
| X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application (DEN230034) | Scopio Labs , Ltd. | 2024-03-22 |
| Elecsys PTH , Elecsys PTH STAT (K231927) | Roche Diagnostics | 2024-03-22 |
| Dukal SMS Sterilization Wrap (K233262) | Dukal, LLC | 2024-03-22 |