| i-STAT CG8+ cartridge with the i-STAT 1 System (K230275) | Abbott Point of Care, Inc. | 2023-10-27 |
| CoreLink Robotic Navigation Instruments (K231494) | Corelink, LLC | 2023-10-27 |
| PodSKAN HF Diagnostic X-ray System (K231761) | Skanray Technologies Limited | 2023-10-27 |
| OR3O Dual Mobility Liners (K232667) | Smith & Nephew, Inc. | 2023-10-27 |
| Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen (K213146) | Jiangsu Rongye Technology Co., Ltd. | 2023-10-27 |
| GIA™ Stapler with Tri-Staple™ Technology (K231934) | Covidien | 2023-10-27 |
| Cold/Hot Compression (K223541) | Jkh Health Co., Ltd. | 2023-10-27 |
| SwiftMR (K230854) | Airs Medical, Inc. | 2023-10-27 |
| 45 Micron Polyisoprene Condom (K231908) | Suretex Limited | 2023-10-27 |
| Modius Sleep (K230826) | Neurovalens , Ltd. | 2023-10-27 |
| Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) (K233187) | Steris | 2023-10-27 |
| BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge (K232393) | Proedge Dental Products, Inc. | 2023-10-27 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) (K233318) | Boston Scientific Corporation | 2023-10-27 |
| Plaxpot Multi Plasma (K220493) | Gcs Co. Limited | 2023-10-27 |
| PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT (K230490) | Dongguan Hunter Electronic Technology Co., Ltd. | 2023-10-27 |
| Polaris X™ Unidirectional Steerable Diagnostic Catheter (K233207) | Boston Scientific Corporation | 2023-10-27 |
| MeVis Liver Suite (K232045) | MeVis Medical Solutions AG | 2023-10-27 |
| hearOAE (K231545) | Hearx SA (Pty) , Ltd. | 2023-10-27 |
| Digital Expert Access with Remote Scanning (K232346) | GE Healthcare | 2023-10-27 |
| SOLACE Sacroiliac Fixation System (K233241) | Ht Medical, LLC Dba Xenix Medical | 2023-10-27 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230300) | Abbott Point of Care, Inc. | 2023-10-27 |
| LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) | DiaSorin, Inc. | 2023-10-27 |
| Aurora Surgiscope System (K232618) | Rebound Therapeutics Corporation | 2023-10-27 |
| DEKA AGAIN PRO family (K233090) | El.En S.P.A. | 2023-10-27 |
| Electronic Blood Pressure Monitor (K231310) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023-10-27 |
| Centrix FluoroSilver Silver Diamine Fluoride 38% (K222459) | Centrix, Inc. | 2023-10-27 |
| Shina Syringe; Shina Safety Syringe (K231165) | Shina Med Corporation | 2023-10-27 |
| EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (K233220) | Senorx, Inc. | 2023-10-27 |
| Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) (K230559) | Medline Industries, Inc. | 2023-10-26 |
| Antimicrobial Gelling Fiber Dressing with PHMB (K213473) | Advanced Medical Solutions, Ltd. | 2023-10-26 |
| MOLLI 2 (K231579) | Molli Surgical, Inc. | 2023-10-26 |
| OGmend® Implant Enhancement System (K233223) | Woven Orthopedic Technologies | 2023-10-26 |
| TE Air Diagnostic Ultrasound System (K231685) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-10-26 |
| Sontro® OTC Hearing Aids (AI) (K231550) | Soundwave Hearing, LLC | 2023-10-26 |
| cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) (K233170) | AtriCure, Inc. | 2023-10-26 |
| Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) (K233091) | Qura S.R.L | 2023-10-26 |
| SIMDA abutment (K232271) | Simda Co., Ltd. | 2023-10-26 |
| Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs (K230662) | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-26 |
| PressON Spinal Fixation System (K233234) | Nexus Spine, LLC | 2023-10-26 |
| NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320) | Medtronic Xomed, Inc. | 2023-10-26 |
| Lumify Diagnostic Ultrasound System (K232500) | Philips Ultrasound | 2023-10-26 |
| Electric Breast Pump (K231595) | Shenzhen Changkun Technology Co., Ltd. | 2023-10-26 |
| ANAX™ 5.5 Spinal System (K231737) | Innosys Co., Ltd. | 2023-10-26 |
| Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) (K230500) | Jiangsu Maxf Electric Appliance Co., Ltd. | 2023-10-26 |
| Luja Coude (20108 Male CH18 - large packaging) (K233101) | Coloplast Corp. | 2023-10-26 |
| AllTest Fentanyl Urine Test Cassette (K233417) | Hangzhou AllTest Biotech Co., Ltd. | 2023-10-26 |
| K3900 Ultrasound Imaging System (K230511) | Maui Imaging | 2023-10-25 |
| BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645) | Avery Dennison Medical , Ltd. | 2023-10-25 |
| POWERSEAL Sealer and Divider (K231327) | Gyrus Acmi, Inc. | 2023-10-25 |
| AcuityUDR (K231995) | Radmedix, LLC | 2023-10-25 |
| UNIdental Symphony Implant System (K221315) | Unidental Co., Ltd. | 2023-10-25 |
| Newclip Patient-matched instrumentation non sterile PSI (K221615) | Newclip Technics | 2023-10-25 |
| SignalHF (IM008) (K230842) | Implicity, Inc. | 2023-10-25 |
| Rapid SDH (K232436) | Ischemaview, Inc. | 2023-10-25 |
| Penumbra LP Coil System (K230284) | Penumbra, Inc. | 2023-10-25 |
| Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro (K232235) | The Magstim Company , Ltd. | 2023-10-25 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K231069) | Spineart SA | 2023-10-25 |
| ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (K233113) | Starmed Co., Ltd. | 2023-10-25 |
| PiXel8-RF (K233147) | Rohrer Aesthetics | 2023-10-25 |
| Balanced Knee® System TriMax PS Plus Tibial Insert (K233093) | Ortho Development Corporation | 2023-10-25 |
| VVR Generator system (K222997) | Starmed Co., Ltd. | 2023-10-25 |
| sam CS Long Duration Ultrasound Device (K233210) | ZetrOZ Systems, LLC | 2023-10-25 |
| REUNION Sacroiliac Joint Fusion System (K232211) | Astura Medical | 2023-10-24 |
| Laser Cap, Model: Hat-01 (K232356) | Hubei Yjt Technology Co.,Ltd | 2023-10-24 |
| Steerant™ Super Stiff Guidewire (K232570) | Medtronic Vascular | 2023-10-24 |
| PlaDuo System (K232223) | ShenB Co., Ltd. | 2023-10-24 |
| Knotilus+ PEEK Knotless Anchor (K232683) | Stryker Endoscopy | 2023-10-24 |
| spineEOS (K232086) | Eos Imaging | 2023-10-24 |
| Acumen IQ finger cuff (K230919) | Edwards Lifesciences, LLC | 2023-10-24 |
| Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter (K232584) | Vein 360, LLC | 2023-10-24 |
| 16 Breast Coil (K233348) | Philips Medical System Nederlands B.V. | 2023-10-24 |
| VISULAS green (K232051) | Carl Zeiss Meditec | 2023-10-24 |
| MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System (K233185) | C2dx, Inc. | 2023-10-24 |
| Sonopuls 190 (K230472) | Enraf-Nonius, B.V. | 2023-10-24 |
| FilteredFlo Warming Blankets (K232638) | Iob Medical, Inc. | 2023-10-24 |
| Aco Apache Ultrasound System (K231509) | Aco Healthcare Co., Ltd. | 2023-10-24 |
| Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (K232586) | K&J Consulting Corp. | 2023-10-24 |
| Swiss LthoClast Trilogy (K230893) | E.M.S Electro Medical Systems S.A | 2023-10-23 |
| Ultrasound System 1300 (K231764) | Bk Medical Aps | 2023-10-23 |
| Applanation Tonometer HT-5000 (K232143) | Huvitz Co., Ltd. | 2023-10-23 |
| Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set (K232205) | Vesco Medical, LLC | 2023-10-23 |
| Ripley Spinal Screw System by SAGICO (K232561) | Sagico VA USA, LLC | 2023-10-23 |
| VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201) | bioMerieux, Inc. | 2023-10-23 |
| AI-Rad Companion Brain MR (K232305) | Siemens Medical Solutions U.S.A. | 2023-10-23 |
| MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560) | Siemens Medical Solutions USA, Inc. | 2023-10-23 |
| PICOCLAMP (K230281) | Kono Seisakusho Co., Ltd. | 2023-10-23 |
| CleanSeal Advanced Bipolar Vessel Sealer Maryland (K231732) | Conmed Corporation | 2023-10-23 |
| Shadow Knotless All-Suture Anchors (K233258) | Responsive Arthroscopy, LLC | 2023-10-23 |
| JO Coconut Hybrid Cooling Personal Lubricant (K232091) | CC Wellness, LLC | 2023-10-22 |
| pRESET LITE Thrombectomy Device (K231539) | Phenox Limited | 2023-10-21 |
| Unicare (K-UNICARE-USA) (K230983) | Tenscare, Ltd. | 2023-10-20 |
| V-PRO maX 2 Low Temperature Sterilization System (K233065) | Steris | 2023-10-20 |
| GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (K231902) | Ansell Healthcare | 2023-10-20 |
| Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809) | Ulrich Medical USA | 2023-10-20 |
| TuxDeluxe (Size 1 6100B, Size 2 6101B) (K232552) | Tuxedo Imaging, LLC | 2023-10-20 |
| Sonix Health (K230209) | Ontact Health Co., Ltd. | 2023-10-20 |
| SPECTRALIS HRA+OCT and variants (K223557) | Heidelberg Engineering GmbH | 2023-10-20 |
| Echo (K232236) | Quanta System Spa | 2023-10-20 |
| NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); (K232042) | Mediconcepts Technology (Shenzhen) Company Limited | 2023-10-20 |
| Pure-Vu EVS System (K232922) | Motus GI Medical Technologies , Ltd. | 2023-10-20 |