| Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (K240806) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 |
| Solo+ Tympanostomy Tube Device (TTD) (K232702) | Aventamed Dac | 2024-05-20 |
| Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) (K240772) | Hunan Ceramaster Material Technology Co., Ltd. | 2024-05-20 |
| Diode Laser Hair Removal System (SH-VD910) (K240520) | Beijing Sea Heart International Science and Technologyco.Ltd | 2024-05-20 |
| Dentis s-Clean SQ-SL Fixture (K240511) | Dentis Co., Ltd. | 2024-05-20 |
| MIM - Centiloid Scaling (K233620) | Mim Software, Inc. | 2024-05-20 |
| AViTA Pulse Oximeter (K223399) | Avita Corporation | 2024-05-20 |
| Vector™ Pedicle Screw System (K241276) | Innovasis, Inc. | 2024-05-20 |
| Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (K233341) | Covidien, LLC | 2024-05-20 |
| Disposable Vinyl Examination Gloves (K241252) | Anqing Pukang Medical Technology Co., Ltd. | 2024-05-20 |
| Multi-function Platform Systems (BL-M10) (K240474) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-20 |
| Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619) | Edwards Lifesciences | 2024-05-20 |
| Radiance V5 (K233236) | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 |
| Intense Pulsed Light System (ST-690) (K240482) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| Yoni.Fit Bladder Support (K232525) | Watkins-Conti Products, Inc. | 2024-05-17 |
| Sentec Digital Monitoring System (SDMS) tCOM+ (K232516) | Sentec AG | 2024-05-17 |
| uOmnispace.CT (K233209) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-17 |
| DentalMonitoring (DEN230035) | Dental Monitoring Sas | 2024-05-17 |
| CIRRUS™ HD-OCT Model 6000 (K233933) | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| Kahook Dual Blade Glide (KDB Glide) (K220891) | New World Medical, Inc. | 2024-05-17 |
| ARENAL Anterior Cervical Plate System (K240935) | Effortmed, LLC | 2024-05-17 |
| MiRus MoRe Lumbar Plating System (K241175) | MiRus, LLC | 2024-05-17 |
| icotec Anterior Cervical Plate System (K233215) | Icotec AG | 2024-05-17 |
| Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (K232793) | Zevex, Inc. | 2024-05-17 |
| SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042) | Pressure Products Medical Device Manufacturing, LLC | 2024-05-17 |
| Wedge XL Delivery Catheter (K232542) | MicroVention, Inc. | 2024-05-16 |
| DEKA LOTUS (K233473) | El.En S.P.A. | 2024-05-16 |
| Sempulse Halo Vital Signs Monitor (K232495) | Sempulse Corporation | 2024-05-16 |
| Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (K232849) | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 |
| eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (K240328) | Signifier Medical Technologies, Ltd. | 2024-05-16 |
| HD80 Series Ultrasound Diagnostic System (K233841) | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-05-16 |
| DEKA TORO (K240752) | El.En S.P.A. | 2024-05-16 |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. (K240445) | Thermo Fisher Scientific | 2024-05-16 |
| RAYDENT SW (K233625) | Ray Co., Ltd. | 2024-05-16 |
| ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039) | Reshape Lifesciences | 2024-05-16 |
| Pain Therapy Device(Model: P.T.S-X) (K230711) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-05-16 |
| Stimulation System (PA series, PR series, S series and Q series) (K232786) | Edan Instruments, Inc. | 2024-05-16 |
| AirKEE P900 (K232933) | Healkee Medical Pte, Ltd. | 2024-05-16 |
| Ticare Dental Implant Systems (K233137) | Mozograu S.A. | 2024-05-16 |
| FAgamin® (K240059) | Tedequim Srl | 2024-05-16 |
| Picosecond Nd:YAG Laser Systems (BL-C10) (K240386) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-16 |
| Augment Off-Axis Instrument System (K241043) | Fix Surgical | 2024-05-15 |
| Notal Vision Home Optical Coherence Tomography (OCT) System (DEN230043) | Notal Vision, Inc. | 2024-05-15 |
| Full Wedge Lateralized and Augmented Baseplates (K240278) | Fx Shoulder USA, Inc. | 2024-05-15 |
| MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053) | Medtronic Cardiac Surgery | 2024-05-15 |
| BriefCase-Quantification (K241112) | Aidoc Medical , Ltd. | 2024-05-15 |
| BruxZir® NOW SRC (K231940) | Prismatik Dentalcraft, Inc. | 2024-05-15 |
| CANON Fundus Camera CR-10 (CR-10) (K241049) | Canon, Inc. | 2024-05-15 |
| Heuron ICH (K233247) | Heuron Co., Ltd. | 2024-05-15 |
| E3D™-A Interbody System (K240368) | Evolution Spine | 2024-05-15 |
| TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (K233985) | Megin OY | 2024-05-15 |
| Aventus Clot Management System (K240426) | Inquis Medical | 2024-05-14 |
| Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) (K233913) | Aoj Health Technology Co., Ltd. | 2024-05-14 |
| BNLE Hydrophilic Jacketed Peripheral Guidewire (K232662) | Biomerics Nle | 2024-05-14 |
| BEAR 2 Body (K232242) | Foreo, Inc. | 2024-05-13 |
| Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) (K240949) | Healgen Scientific,, LLC | 2024-05-13 |
| 1060nm laser body slimming machine (K240658) | Hebei JT Medical Co., Ltd. | 2024-05-13 |
| MIM – Monte Carlo Dosimetry (K232862) | Mim Software, Inc. | 2024-05-13 |
| Brainomix 360 e-Lung (K233875) | Brainomix Limited | 2024-05-13 |
| Disposable Double Lumen Endobronchial Tube (K232529) | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 |
| Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) (K232614) | Sri Trang Gloves (Thailand) Public Company Limited | 2024-05-13 |
| REMEX-GR100 (K240759) | Remedi Co., Ltd. | 2024-05-13 |
| Access OV Monitor (K240479) | Beckman Coulter, Inc. | 2024-05-10 |
| Ureterorenoscope System (K240374) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 |
| Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (K240708) | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 |
| Bioceramic Root Repair Material (C-Root BP) (K240365) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024-05-10 |
| Aerogen®Solo Nebulizer System (K232507) | Aerogen, Ltd. | 2024-05-10 |
| pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 |
| Filter Needle for Single Use (K233277) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-10 |
| APERTO Lucent MRI System (K233629) | FUJIFILM Healthcare Americas Corporation | 2024-05-10 |
| HyperSuture Extension Line (K234079) | Threadstone, LLC | 2024-05-10 |
| Disposable infusion set with needle (K232475) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024-05-10 |
| Oocyte Flushing & Retrieval Medium; Gamete Buffer (K234023) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-05-10 |
| QIAstat-Dx® Respiratory Panel Plus (K233100) | QIAGEN GmbH | 2024-05-10 |
| SmartChest (K232410) | Milvue | 2024-05-10 |
| Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (K240698) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 |
| SCARLET® AC-Ti (K240699) | Spineart SA | 2024-05-10 |
| PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (K240276) | Given Imaging Ltd. (D.B.A. Medtronic) | 2024-05-10 |
| Polyisoprene Extra Large Condom (K232470) | Suretex Limited | 2024-05-09 |
| P200TE (A10700) (K233602) | Optos Plc. | 2024-05-09 |
| Flexible Fixation Device for Gynecological Applicators (GM11001960) (K240495) | Varian Medical Systems, Inc. | 2024-05-09 |
| Access BR Monitor (K240403) | Beckman Coulter, Inc. | 2024-05-09 |
| DePuy Synthes MatrixSTERNUM Fixation System (K233967) | Synthes GmbH | 2024-05-09 |
| VUZE System (K232976) | Vuze Medical , Ltd. | 2024-05-09 |
| Biofourmis Everion+ (G2) (K233418) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| CEREGLIDE 92 Catheter System (K233982) | Cerenovus, Inc. | 2024-05-09 |
| Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) (K232477) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2024-05-09 |
| Dental Barrier and Sleeves (K233918) | Yongqing Huaguan Dental Instruments Factory | 2024-05-09 |
| Hushd Pro Avera (K232025) | Good Sleep CO Pte , Ltd. | 2024-05-09 |
| SC Medica FFX (K232468) | Sc Medica | 2024-05-09 |
| Tulsa Pro System (Pad-105) (K240296) | Profound Medical, Inc. | 2024-05-09 |
| Customized Abutment (K234112) | Arum Dentistry Co., Ltd. | 2024-05-09 |
| Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) (K241008) | Relign Corporation, Subsidiary of Zimmer Biomet | 2024-05-08 |
| Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K232649) | Pegavision Corporation | 2024-05-08 |
| Legend X Applicator VO (K240999) | Pollogen, Ltd. | 2024-05-08 |
| FLOW 90? Wand (K240964) | ArthroCare Corporation | 2024-05-08 |
| F&P myAirvo 3 (K222292) | Fisher & Paykel Healthcare | 2024-05-08 |
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| UltraClear Laser System (N/A) (K233803) | Acclaro Corporation | 2024-05-08 |
| AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (K234039) | Lexington Medical, Inc. | 2024-05-07 |