| Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (K241451) | Teleflex Incorporated | 2025-02-11 |
| LONGY Implant and LONGY-N Implant (K241462) | Noris Medical , Ltd. | 2025-02-11 |
| Vivid T9/Vivid T8 (K243628) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (K243155) | Dongguan Zsr Biomedical Technology Company Limited | 2025-02-11 |
| cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867) | Roche Molecular Systems, Inc. | 2025-02-11 |
| InSet Total Shoulder System (K241817) | Shoulder Innovations, Inc. | 2025-02-11 |
| Ultrasound Workspace (UWS 6.0) (K241659) | Philips Ultrasound, LLC | 2025-02-10 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (K243201) | Thermo Fisher Scientific | 2025-02-10 |
| Locking Plates and Screws Systems (K240958) | Hebei Ruihe Medical Devices Co., Ltd. | 2025-02-10 |
| Calcium2 (K244042) | Abbott Ireland | 2025-02-10 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (K242905) | Thermo Fisher Scientific | 2025-02-10 |
| BTL-398 (K241516) | BTL Industries, Inc. | 2025-02-10 |
| Remi Custom Night Guard (K243516) | Grindguard, Inc. | 2025-02-10 |
| Myolight Microcurrent Handpiece (K243063) | Raja Trading Company, Inc. | 2025-02-10 |
| Philips Lumea IPL (K243453) | Philips Consumer Lifestyle B.V. | 2025-02-10 |
| OTC TENS & EMS Unit (K243511) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-02-10 |
| Any-Com Bulk (K242713) | Mediclus Co., Ltd. | 2025-02-07 |
| Symani Surgical System (K242368) | Medical Microinstruments, Inc. | 2025-02-07 |
| AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (K243996) | Assure Tech., LLC | 2025-02-07 |
| Electronic Blood Pressure Monitor (K243661) | Hetaida Technology Co., Ltd. | 2025-02-07 |
| Genesys Spine AIS-C II Cervical Interbody Fusion System (K242483) | Genesys Spine | 2025-02-07 |
| Endoscopic Video Image Processor (RP-IPD-V1000F) (K243321) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 |
| Elecsys sFlt-1 and Elecsys PlGF (K241453) | Roche Diagnostics | 2025-02-07 |
| ceramys™ femoral head system (K241483) | Encore Medical L.P. | 2025-02-07 |
| HELIOS 785 Pico (1754V2) (K243780) | Laseroptek Co., Ltd. | 2025-02-07 |
| BDC Dental Unit (K242404) | Bdc Dental Corporation , Ltd. | 2025-02-07 |
| Identify (4.0) (K242957) | Varian Medical Systems, Inc. | 2025-02-07 |
| Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (K242428) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 |
| Delphi MCS Electrode Cap (K243243) | Quantalx Neuroscience, Ltd. | 2025-02-06 |
| VIVACE (K242111) | Unimom.Co | 2025-02-06 |
| DUTAU-NOVATECH® (K242324) | Novatech SA | 2025-02-06 |
| Signature Osteosynthesis Plate System (K241599) | Signature Orthopaedic Pty , Ltd. | 2025-02-06 |
| CROSSLEAD 0.014inch (K241702) | Asahi Intecc Co., Ltd. | 2025-02-06 |
| Disposable Sphincterotome (K242192) | Beijing Zksk Technology Co., Ltd. | 2025-02-06 |
| Stryker Orthopaedics Hip Devices Labeling Update (K243784) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (K242977) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034) | Ever Global (Vietnam) Enterprise Corporation | 2025-02-06 |
| Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (K242580) | Unimed Medical Supplies, Inc. | 2025-02-06 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K250044) | STERIS Corporation | 2025-02-06 |
| Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (K250066) | Boston Scientific Corporation | 2025-02-06 |
| VMAT PRO (K243488) | Termosalud | 2025-02-06 |
| Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert (K243817) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| BPS - Bone Fragment Fixation Plates, Screws and Washers (K250055) | Orthonovis, Inc. | 2025-02-06 |
| Celerity Incubator (K250061) | STERIS Corporation | 2025-02-06 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243794) | Philips Ultrasound, LLC | 2025-02-06 |
| Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (K243465) | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2025-02-06 |
| Caliber Intramedullary Fixation System (K242896) | Nvision Biomedical Technologies | 2025-02-05 |
| GraftGun Universal Graft Delivery System (GDS) (K243580) | SurGenTec, LLC | 2025-02-05 |
| Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327) | Claronav | 2025-02-05 |
| GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (K243790) | Depuy Mitek | 2025-02-05 |
| Accurate Mini Non-invasive blood pressure monitor (AMB-001) (K242352) | Accurate Meditech, Inc. | 2025-02-05 |
| TrainFES Advance (K241488) | Trainfes | 2025-02-05 |
| BoneMetrics (US) (K241593) | Gleamer Sas | 2025-02-05 |
| CROMA Electrosurgical Generator (PRD-EMR-050) (K242983) | Creo Medical, Ltd. | 2025-02-05 |
| LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (K243555) | Shenzhen Eyco Technology Co., Ltd. | 2025-02-05 |
| Venclose digiRF Generator (VCRFG1) (K250068) | Venclose, Inc. | 2025-02-04 |
| rTOP (K243333) | Roclub GmbH | 2025-02-04 |
| Geon (S2) Nasal Aspirator (K243138) | Geon Corporation | 2025-02-04 |
| Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (K242916) | Largan Medical Co., Ltd. | 2025-02-04 |
| Tiger 2 System (K243908) | Zavation Medical Products, LLC | 2025-02-03 |
| Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454) | Guangzhou Hehong Biotech Co., Ltd. | 2025-02-03 |
| Sonicaid Team3 (K241368) | Huntleigh Healthcare , Ltd. | 2025-02-03 |
| Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (K243182) | Momentis Surgical , Ltd. | 2025-02-03 |
| JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (K243393) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-02-03 |
| TipTraQ (TTQ001) (K243268) | Pranaq Pte. , Ltd. | 2025-02-03 |
| Contour ProtégéAI+ (K250035) | Mim Software, Inc. | 2025-02-03 |
| IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (K241375) | Alphatec Spine | 2025-02-03 |
| Cito CBC System (K240402) | Cytochip, Inc. | 2025-02-03 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (K241590) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 |
| Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (K241334) | C.R. Bard, Inc. | 2025-01-31 |
| Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135) | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (K243441) | Basic Medical Technology, Inc. | 2025-01-31 |
| Mobility Scooter (MS160A) (K242982) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-01-31 |
| Nuance Audio Hearing Aid Software (K243150) | Luxottica Group S.P.A. | 2025-01-31 |
| AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (K241193) | Marzzan Lucas Jorge | 2025-01-31 |
| Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966) | Gentuity, LLC | 2025-01-31 |
| SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348) | Motilitycount Aps | 2025-01-31 |
| Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K242442) | Innovate Orthopaedics, Ltd. | 2025-01-31 |
| Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (K243665) | ZheJiang Decans Medical Devices Co., Ltd. | 2025-01-31 |
| Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (K243572) | Avanos Medical, Inc. | 2025-01-31 |
| ZeTTA PACS (K241694) | Tae Young Soft Co., Ltd. | 2025-01-31 |
| Arthrex DynaNite Nitinol Staples (K243742) | Arthrex, Inc. | 2025-01-31 |
| Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (K243820) | Dornier Medtech America | 2025-01-31 |
| MyShoulder Planner (5.3SSWPL) (K241292) | Medacta International S.A. | 2025-01-30 |
| BTL-754 (K241270) | BTL Industries, Inc. | 2025-01-30 |
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
| iBOT® PMD (K243442) | Mobius Mobility | 2025-01-30 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717) | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| Ureteral Access Sheath (K243025) | Seplou (Zhuhai) Co., Ltd. | 2025-01-30 |
| Osprey Suture Anchor (K243726) | Responsive Arthroscopy, Inc. | 2025-01-30 |
| Rotarex Atherectomy System (K242757) | Bard Peripheral Vascular, Inc. | 2025-01-30 |
| TeleRPM Gen2 Blood Glucose Monitoring System (K243060) | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 |
| Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025-01-30 |
| Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (K233956) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-01-30 |
| MTS Ceftobiprole 0.002-32 µg/mL (K243202) | Liofilchem s.r.l. | 2025-01-30 |
| WasherCap™ Mini Fixation System (Model 45) (K243712) | Abanza Tecnomed S.L | 2025-01-30 |
| Surcam Dental Implant System (K242217) | Surcam Medical Devices and Developments, Ltd. | 2025-01-29 |
| CareSuperb™ COVID-19 Antigen Home Test (K241915) | Access Bio, Inc. | 2025-01-29 |
| Co-Ablation System with Sterile Co-Ablation Probe (K243042) | Hygea Medical Technology Co., Ltd. | 2025-01-29 |