FDA 510(k) clearances — page 4

176,428 clearances on record, most recent first.

Clearances — page 4

301–400 of 176,428

K262050 — Vioseal XSpident Co., Ltd.·Product code KIF·2026-09-11
K262151 — SpaceOAR Flex SystemBoston Scientific Corporation·Product code OVB·2026-09-11
K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETEBone Solutions, Inc.·Product code MQV·2026-09-11
K262397 — CuratOR EX2742Eizo Corporation·Product code GCJ·2026-09-11
K262763 — iLet Dosing Decision SoftwareBeta Bionics, Inc.·Product code QJI·2026-09-11
K262861 — PureLift Pro MaxXtreem Pulse, LLC·Product code NFO·2026-09-11
K262874 — CraniUS PlateCraniUS, LLC·Product code GWO·2026-09-11
K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.·Product code HAW·2026-09-10
K254009 — Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)Lakong Medical Devices Co., Ltd.·Product code SJH·2026-09-10
K254074 — TruPressProcerus Enterprises·Product code DRS·2026-09-10
K254111 — Irrigation/Urology SetsB.Braun Medical, Inc.·Product code LJH·2026-09-10
K254246 — LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.·Product code NAD·2026-09-10
K260110 — danumed Extension Set for Gastrostomy ButtonDanumed Medizintechnik GmbH·Product code PIF·2026-09-10
K260879 — 4DMINVIA, LLC·Product code QIH·2026-09-10
K261409 — BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.·Product code NFT·2026-09-10
K261562 — Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.·Product code GEX·2026-09-10
K261696 — ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.·Product code OBJ·2026-09-10
K261795 — Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.·Product code QIH·2026-09-10
K261929 — Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.·Product code DXN·2026-09-10
K262079 — 4K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.·Product code FET·2026-09-10
K262202 — Cerasmart ForteGC America, Inc.·Product code EBF·2026-09-10
K262293 — EVOLUTION MPX Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.·Product code JWH·2026-09-10
K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.·Product code GEX·2026-09-10
K251417 — ReVISION 2Argus Cognitive, Inc.·Product code QIH·2026-09-09
K252486 — ChestView US (1.1)Gleamer·Product code MYN·2026-09-09
K260652 — ColActive PlusCovalon Technologies, Ltd.·Product code KGN·2026-09-09
K260997 — SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01)Endoclot Plus Co., Ltd.·Product code PLL·2026-09-09
K261470 — QF10E.A.M Benelux B.V·Product code NHV·2026-09-09
K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.·Product code LZA·2026-09-09
K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.·Product code FGB·2026-09-09
K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 moreTop Glove Sdn. Bhd.·Product code LZA·2026-09-09
K253988 — LiteSet TraysNobel Biocare AB·Product code KCT·2026-09-08
K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.·Product code HIH·2026-09-08
K260053 — Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.·Product code ITI·2026-09-08
K260062 — MODI SystemDreaMed Diabetes, Ltd.·Product code QRX·2026-09-08
K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH Corporation·Product code KPR·2026-09-08
K260229 — Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.·Product code ITI·2026-09-08
K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 moreGmp Medicare Sdn. Bhd.·Product code LZA·2026-09-08
K261462 — LANDMARK Total Knee SystemSmith & Nephew, Inc.·Product code MBH·2026-09-08
K261715 — Emboliner Embolic Protection System (EPC-03)Emboline, Inc.·Product code PUM·2026-09-08
K261823 — da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.·Product code NAY·2026-09-08
K261956 — Dental Barriers and Sleeves (AB0006)ANI Co., Ltd.·Product code PEM·2026-09-08
K261987 — Reusable SmartPegOsstell AB·Product code EKX·2026-09-08
K262173 — N22 Offset Humeral HeadShoulder Innovations, Inc.·Product code KWT·2026-09-08
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.·Product code JWH·2026-09-08
K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.·Product code OBP·2026-09-06
K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 moreShenzhen Osto Medical Technology Co.,Ltd·Product code NUH·2026-09-06
K254135 — LipoSurg ARTISTNOUVAG AG·Product code QPB·2026-09-05
K261684 — FreezeSpray TACryosurgery, Inc.·Product code MLY·2026-09-05
K253529 — Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.·Product code MWJ·2026-09-04
K253836 — FCT iStream Phase 2Fujifilm Corporation·Product code JAK·2026-09-04
K253909 — NeoPEX Pre-Mixed Obturation PasteNuSmile, Ltd.·Product code KIF·2026-09-04
K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)·Product code PSZ·2026-09-04
K254264 — Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)·Product code QVF·2026-09-04
K260035 — Digital Indeflator INFLANTEUAB Telemedicina·Product code MAV·2026-09-04
K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd.·Product code DHB·2026-09-04
K260525 — NextMR SpineMRI2CT, Inc.·Product code QIH·2026-09-04
K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,·Product code EZL·2026-09-04
K261057 — ActivaScrew Cannulated COMBioretec, Ltd.·Product code HWC·2026-09-04
K261935 — Surgical and Prosthetic TraysDentsply Sirona, Inc.·Product code KCT·2026-09-04
K262060 — 3D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC·Product code LLZ·2026-09-04
K262130 — ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.·Product code JWH·2026-09-04
K262235 — ApexCut Blade with Automated EM Tracking (6 models)Medtronic Xomed, Inc.·Product code PGW·2026-09-04
K262277 — 70 NeuGlide CatheterPiraeus Medical, Inc.·Product code QJP·2026-09-04
K262292 — Gastric AlimetryAlimetry , Ltd.·Product code MYE·2026-09-04
K262828 — KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O·Product code NKB·2026-09-04
DEN250044 — Queen of Hearts (ACS AI ECG Model)Powerful Medical, Inc.·Product code SHS·2026-09-03
K251794 — Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.·Product code BTR·2026-09-03
K253673 — Mcare System (MW-20)Marani Health, Inc.·Product code LQK·2026-09-03
K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 moreMaxigen Biotech, Inc.·Product code NUC·2026-09-03
K254000 — Happy Health Blood Pressure MonitorHappy Health, Inc.·Product code DXN·2026-09-03
K254035 — Mayumi Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro·Product code QEZ·2026-09-03
K260503 — Triton 1 SystemNeptune Medical, Inc.·Product code FDF·2026-09-03
K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.·Product code DQX·2026-09-03
K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 morePhilips Consumer Lifestyle B.V.·Product code HGX·2026-09-03
K261647 — Tempo Plating System; Ultra Compression Screw SystemPace Surgical·Product code HRS·2026-09-03
K261800 — Helo Max Thrombectomy System (HEL2090)Endovascular Engineering·Product code QEW·2026-09-03
K262243 — Profisil FreeKettenbach GmbH & Co. KG·Product code LBH·2026-09-03
K262315 — NeuroBlate SystemMonteris Medical·Product code ONO·2026-09-03
K262460 — Rezum SystemBoston Scientific·Product code KNS·2026-09-03
K262769 — Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.·Product code MTJ·2026-09-03
K253065 — Aevumed SUPERCYNCH Button SystemAevumed, Inc.·Product code MBI·2026-09-02
K253948 — Momentum Acetabular Cup SystemUnited Orthopedic Corporation·Product code LZO·2026-09-02
K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 moreFlexicare Medical Limited.·Product code EOQ·2026-09-02
K254090 — I-View®Hologic, Inc.·Product code MUE·2026-09-02
K254198 — Trexo TheoTrexo Robotics, Inc.·Product code PHL·2026-09-02
K260432 — Ruby Intravascular CatheterVenocare, Inc.·Product code FOZ·2026-09-02
K261311 — HYALOMATRIXAnika Therapeutics, Inc.·Product code QSZ·2026-09-02
K261313 — Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics·Product code IYN·2026-09-02
K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.·Product code GEX·2026-09-02
K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth·Product code LZA·2026-09-02
K262153 — Pivot Insulin Delivery SystemModular Medical, Inc.·Product code LZG·2026-09-02
K262364 — Ellian Enigma RF DeviceEllian Corp·Product code GEI·2026-09-02
K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical·Product code GEH·2026-09-02
K262809 — ArthroTAK Tendon Anchor KitArthroTAK, LLC·Product code MBI·2026-09-02
K253961 — SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.·Product code JWH·2026-09-01
K260613 — AMI Plasma Cartridge, AMISequitur Health Corp.·Product code JID·2026-09-01
K260656 — Carescape ONE +6 moreGE Healthcare Finland Oy·Product code MHX·2026-09-01
K260758 — MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.·Product code LNH·2026-09-01
K260884 — UNIDRIVE Select SystemKarl Storz SE & CO. KG·Product code GCJ·2026-09-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.