| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K240954) | Shockwave Medical, Inc. | 2024-05-07 |
| LIFEPAK® ECG Cables (K240377) | Stryker Physio-Control | 2024-05-07 |
| Eve Patient Positioner System (K231612) | Leo Cancer Care | 2024-05-07 |
| DeepContour (V1.0) (K232928) | Wisdom Technologies., Inc. | 2024-05-07 |
| KARL STORZ Monopolar Resectoscopes with HF Cable (K232486) | Karl Storz SE & CO. KG | 2024-05-07 |
| Medical HAL Lower Limb Type (HAL-ML) (K233695) | Cyberdyne, Inc. | 2024-05-07 |
| CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018) | Dentsply Sirona | 2024-05-07 |
| Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (K232493) | Wuhan Huchuang Union Technology Co., Ltd. | 2024-05-07 |
| HALO AP Dx (K232833) | Indica Labs, Inc. | 2024-05-07 |
| Geneo X Elite (K233766) | Pollogen, Ltd. | 2024-05-07 |
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |
| MIM – Dose Analysis (K232514) | Mim Software, Inc. | 2024-05-06 |
| Solar Compact (G4-1) (K240007) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| JAZZ Spinal System (K240392) | Implanet | 2024-05-06 |
| Salvo® Spine System (K240685) | Spine Wave, Inc. | 2024-05-06 |
| Vertos mild Device Kit (MDK-0002) (K233800) | Vertos Medical, Inc. | 2024-05-06 |
| ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033) | Boehringer Laboratories, LLC | 2024-05-06 |
| Emily's Care Nourish Test System (Model 1) (K234088) | Lactation Lab, Inc. | 2024-05-03 |
| Megaloop Button System (K232941) | Suzhou Endophix Co., Ltd. | 2024-05-03 |
| Silk Voice (SMI-04) (K240919) | Sofregen Medical | 2024-05-03 |
| Access Intrinsic Factor Ab (K240800) | Beckman Coulter, Inc. | 2024-05-03 |
| Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) (K233524) | Hollister Incorporated | 2024-05-03 |
| CT 5300 (K232491) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-05-03 |
| CORUS Navigation Access System (K240625) | Providence Medical Technology, Inc. | 2024-05-03 |
| Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (K240297) | Us Medical Innovations, LLC | 2024-05-03 |
| ECHELON Synergy V10.0 (K233687) | FUJIFILM Healthcare Americas Corporation | 2024-05-03 |
| RODEO Telescopic Nail (K232648) | Orthofix Srl | 2024-05-03 |
| ProAM ALIF System (K240126) | Pro Surgical, Inc. | 2024-05-03 |
| Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776) | Outset Medical, Inc. | 2024-05-03 |
| B-Ultrasound Diagnostic System (K232895) | Contec Medical Systems Co.,Ltd | 2024-05-03 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| AUTION EYE AI-4510 Urine Particle Analysis System (K232416) | Arkray, Inc. | 2024-05-03 |
| Cypris eXact Suture Placement Device (K240185) | Cypris Medical | 2024-05-03 |
| Mbrace Cable (K232733) | Medacta International S.A. | 2024-05-03 |
| Masimo Stork (K234021) | Masimo Corporation | 2024-05-03 |
| EMA 3D (K232735) | Ema Sleep Incorporated | 2024-05-03 |
| VaporMAX LDD; MOJo LDD; MegaJOULE LDD (K233157) | Innovaquartz, LLC | 2024-05-03 |
| Viral Transport Media (VTM) (K232454) | Alb Luz | 2024-05-03 |
| Vial2Bag Advanced® 20mm Admixture Device (K240940) | West Pharmaceutical Services, Inc. | 2024-05-03 |
| Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) (K240261) | Merit Medical Systems, Inc. | 2024-05-02 |
| HemoScreen Hematology Analyzer (K240636) | Pixcell Medical Technologies | 2024-05-02 |
| Revi™ System (K240037) | Bluewind Medical , Ltd. | 2024-05-02 |
| CSF-4 (CSF-4) (K232445) | Cardiacsense | 2024-05-02 |
| VereSee Optical Veres Needle System (K232464) | Freyja Healthcare, LLC | 2024-05-02 |
| Neodent Implant System – Custom Abutments (K233857) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-05-02 |
| Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) (K232908) | Contec Medical Systems Co.,Ltd | 2024-05-02 |
| Mobility Scooter (W3431) (K240012) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-05-02 |
| Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps (K233752) | CenterPoint Systems, LLC | 2024-05-02 |
| EVA15 insufflator (K232902) | Palliare , Ltd. | 2024-05-02 |
| Hope&Her Vaginal Dilators (K233689) | Lujena, Inc. | 2024-05-02 |
| MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box (K234113) | Medimaging Integrated Solution, Inc (Miis) | 2024-05-01 |
| HOTWIRE™ RF Guidewire (K240900) | Atraverse Medical | 2024-05-01 |
| Remex Spine Surgery Navigation System II (K233513) | Remex Medical Corp. | 2024-05-01 |
| Cold Compression (K240986) | Jkh Health Co., Ltd. | 2024-05-01 |
| Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516) | Reichert, Inc. | 2024-05-01 |
| Soft Tissue Augmentation Resorbable Matrix (K233203) | Collagen Matrix, Inc. | 2024-05-01 |
| DuraGraft Vascular Conduit Solution (K240925) | Marizyme | 2024-05-01 |
| BruxZir® Esthetic (K240882) | Prismatik Dentalcraft, Inc. | 2024-05-01 |
| AuST Steerable Sheath (K240829) | CenterPoint Systems, LLC | 2024-05-01 |
| ORskin Blue (K232858) | Megabay S.A. | 2024-05-01 |
| Vial Adapter with Filter (K233284) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 |
| SmarTooth (K231722) | Smartooth Co., Ltd. | 2024-05-01 |
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| Percutaneous Nephroscope System (K232370) | Karl Storz SE & CO. KG | 2024-05-01 |
| LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (K240156) | Physio-Control, Inc. | 2024-04-30 |
| Flexset System (K233403) | Zeto, Inc. | 2024-04-30 |
| Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) (K232923) | Varian Medical Systems, Inc. | 2024-04-30 |
| Morpheus® Moldable; Agilon® Moldable (K240621) | Biogennix, LLC | 2024-04-30 |
| Protective Cap (K232528) | Neobiotech Co., Ltd. | 2024-04-30 |
| High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) (K233122) | Litu Tech , Ltd. | 2024-04-30 |
| Dental Implants and Abutments (K233231) | Ditron Dental, Ltd. | 2024-04-30 |
| METICULY Patient-specific titanium maxillofacial mesh implant (K232889) | Meticuly Co., Ltd. | 2024-04-30 |
| Picosecond Nd:YAG Laser System (K240118) | Smedtrum Medical Technology Co., Ltd. | 2024-04-30 |
| XTRA Autotransfusion System (with XTRA Bowl sets) (K240584) | Sorin Group Italia S.R.L. | 2024-04-29 |
| DuraPro™ Oscillating System (K240568) | Globus Medical, Inc. | 2024-04-29 |
| restor3d Kinos Axiom Total Ankle System (K240591) | Restor3D, Inc. | 2024-04-29 |
| Blood Pressure Monitor (TMB-2287-B) (K240102) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-04-29 |
| SubtleREFORMAT (1.x) (K233699) | Subtle Medical, Inc. | 2024-04-29 |
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |
| POWEReam Xia/Serrato (K240526) | Stryker Instruments | 2024-04-29 |
| Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939) | Boston Scientific | 2024-04-29 |
| ARVIS® Shoulder (K240062) | Insight Medical Systems, Inc. | 2024-04-29 |
| Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (K232511) | Surgical Instrument Service and Savings, Inc. | 2024-04-29 |
| Volnewmer™ (K240248) | Classys, Inc. | 2024-04-29 |
| NB Mini Implant System (K240091) | Arum Dentistry Co., Ltd. | 2024-04-26 |
| TME Temporary Myocardial Electrode (K232261) | Osypka AG | 2024-04-26 |
| Rhinolaryngoscope system (K232435) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 |
| FCT iSTREAM Phase 1 (K233583) | FUJIFILM Healthcare Americas Corporation | 2024-04-26 |
| UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (K232317) | Urit Medical Electronic Co., Ltd. | 2024-04-26 |
| uMR Jupiter (K233673) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 |
| Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) | Clariance | 2024-04-26 |
| Sonio Detect (K240406) | Sonio | 2024-04-26 |
| Bone Anchor (NGS-BA-01) (K233703) | ClearPoint Neuro, Inc. | 2024-04-26 |
| cobas pulse blood glucose monitoring system (K220272) | Roche Diagnostics | 2024-04-26 |
| Reef L Interbody System; WaveForm L Interbody System (K240566) | SeaSpine Orthopedics Corporation | 2024-04-26 |
| EMPOWR Revision Symmetric Knee Cones (K240324) | Encore Medical, L.P. (Dba Enovis) | 2024-04-26 |
| DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (K232298) | Canon, Inc. | 2024-04-26 |
| syngo.via RT Image Suite (K232799) | Siemens Medical Solutions USA, Inc. | 2024-04-26 |
| Pocket III (K232302) | Quantel Medical | 2024-04-26 |
| XLO Brand of Locking Distal Humerus Plating System (K233873) | Ortho Life Systems Private Limited | 2024-04-26 |