| K242651 — GM85 | Samsung Electronics Co., Ltd. Oct 1, 2024 |
| K240917 — Esperance 3+ Aspiration Catheter System | Wallaby Medical Oct 1, 2024 |
| K242277 — Crown HT | Sprintray, Inc. Oct 1, 2024 |
| K241967 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific Oct 1, 2024 |
| K241331 — MuscleView | Springbok, Inc. Oct 1, 2024 |
| K240943 — LungVision | Bodyvision Medical , Ltd. Oct 1, 2024 |
| K241285 — Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Oct 1, 2024 |
| K242498 — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. Oct 1, 2024 |
| K240331 — Electric wheelchair (YHWL002, YHWL003) | Yongkang Youha Electric Appliance Co., Ltd. Oct 1, 2024 |
| K241657 — MSFX MIKRON SPINAL FIXATION SYSTEM | Mikron Makina Sanayi VE Ticaret Ltd. Sti. Sep 30, 2024 |
| K241151 — LUXEN 5G | Dentalmax Co., Ltd. Sep 30, 2024 |
| DEN230011 — OcuCool | Recensmedical, Inc. Sep 30, 2024 |
| K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. Sep 30, 2024 |
| K241952 — AQUABEAM Robotic System (AB2000) | Procept Biorobotics Sep 30, 2024 |
| K242154 — Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. Sep 30, 2024 |
| K241836 — Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation Sep 30, 2024 |
| K242276 — CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. Sep 30, 2024 |
| K210933 — YSI 2900C Biochemistry Analyzer | Ysi, Inc. Sep 30, 2024 |
| DEN240017 — ShortCut | Pi-Cardia, Ltd. Sep 27, 2024 |
| K241536 — trophon Wireless Ultrasound Probe Holder | Nanosonics Limited Sep 27, 2024 |
| K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. Sep 27, 2024 |
| K240745 — ID Free Personal Lubricant | Westridge Laboratories, Inc. Sep 27, 2024 |
| K241447 — iCare ST500 (TA04) | Icare Finland OY Sep 27, 2024 |
| K241916 — TearRepair Liquid Skin Protectant | Optmed, Inc. Sep 27, 2024 |
| K241933 — HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Sep 27, 2024 |
| K240993 — encevis (2.1) | Ait Austrian Institute Of Technology GmbH Sep 27, 2024 |
| K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | Hyundae Meditech Co., Ltd. Sep 27, 2024 |
| K242557 — ClotTriever XL Catheter (41-102) | Inari Medical, Inc. Sep 27, 2024 |
| K233446 — AMC Health CareConsole | Amc Health Sep 27, 2024 |
| K241480 — JBS-LVO | JLK, Inc. Sep 27, 2024 |
| K242582 — Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC Sep 27, 2024 |
| K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. Sep 27, 2024 |
| K240220 — Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. Sep 27, 2024 |
| K241939 — EasyCare Tx 2 | Resmed Corp Sep 27, 2024 |
| K240369 — CAC (gated) Algorithm | BunkerHill Health Sep 27, 2024 |
| K242125 — Elvie Stride 2 | Chiaro Technology, Ltd. Sep 27, 2024 |
| K241909 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. Sep 27, 2024 |
| K241513 — Sourcerer | Brain Electrophysiology Laboratory Company, LLC Sep 27, 2024 |
| K242206 — ACTIVO | Daeju Meditech Engineering Co., Ltd. Sep 27, 2024 |
| K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP Sep 27, 2024 |
| K241147 — Any-Com | Mediclus Co., Ltd. Sep 26, 2024 |
| K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. Sep 26, 2024 |
| K241651 — Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. Sep 26, 2024 |
| K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | Circa Scientific, Inc. Sep 26, 2024 |
| K242632 — Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. Sep 26, 2024 |
| K241815 — Protean Fragment Plating System | Skeletal Dynamics, Inc. Sep 26, 2024 |
| K241895 — Cannulated PsiFGuard | Spineguard Sep 26, 2024 |
| K240854 — Accelerate Arc System | Accelerate Diagnostics, Inc. Sep 26, 2024 |
| K241101 — BioButton System | Biointellisense, Inc. Sep 26, 2024 |
| K241341 — cryo-GO Vitrification Device | Fujifilm Irvine Scientific Sep 26, 2024 |