FDA 510(k) clearances — page 75

176,479 clearances on record, most recent first.

Clearances — page 75

7,401–7,500 of 176,479

K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG·Product code KPS·2024-07-15
K241385 — Omnifix Syringe NRFitB.Braun Medical, Inc.·Product code QEH·2024-07-13
DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)Terragene S.A.·Product code QVB·2024-07-12
K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical·Product code GAM·2024-07-12
K233457 — RUSHutom, Inc.·Product code QIH·2024-07-12
K233557 — HemoCare Hemodialysis SystemDeka Research and Development·Product code KDI·2024-07-12
K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)Megadyne Medical Products, Inc.·Product code GEI·2024-07-12
K233834 — Infinity Gateway SuiteDraeger Medical Systems, Inc.·Product code MSX·2024-07-12
K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical·Product code QIH·2024-07-12
K234077 — SPIRA® Anterior Lumbar SpacersCamber Spine Technologies·Product code MAX·2024-07-12
K234124 — Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd.·Product code PKL·2024-07-12
K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsPrismatik Dentalcraft, Inc.·Product code NHA·2024-07-12
K240247 — MoFi Cell Culture Basal MediumDuogenic Stemcells Corporation·Product code NDS·2024-07-12
K240651 — MRI UniversalStryker Leibinger GmbH & Co KG·Product code JEY·2024-07-12
K240661 — Geistlich Bio-Oss®Geistlich Pharma AG·Product code NPM·2024-07-12
K240920 — HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development·Product code KPO·2024-07-12
K241018 — KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.·Product code HRS·2024-07-12
K241031 — TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.·Product code OLO·2024-07-12
K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC·Product code GEI·2024-07-12
K241378 — S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.·Product code KCT·2024-07-12
K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.·Product code FAJ·2024-07-12
K241705 — MilkMate Breast Pump (A0006) +2 moreMilkmate Products, Inc.·Product code HGX·2024-07-12
K241707 — OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEALUnicon Optical Co., Ltd.·Product code LPL·2024-07-12
K241713 — HiRise (1040-230)Curvebeam, LLC·Product code JAK·2024-07-12
K241715 — Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd.·Product code EIH·2024-07-12
K241720 — VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc.·Product code DRE·2024-07-12
K241727 — BriefCase-TriageAidoc Medical , Ltd.·Product code QAS·2024-07-12
K233791 — Drivewire 24 GuidewireRapid-Medical , Ltd.·Product code MOF·2024-07-11
K233874 — tmCMF SolutionTechmah Cmf·Product code JEY·2024-07-11
K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation·Product code LFL·2024-07-11
K241000 — ATTUNE Revision Knee System +6 moreDepuy Ireland UC·Product code JWH·2024-07-11
K241006 — Natural CyclesNatural Cycles Nordic AB·Product code PYT·2024-07-11
K241022 — Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd·Product code GEI·2024-07-11
K241329 — SubtleSYNTH (1.x)Subtle Medical, Inc.·Product code QIH·2024-07-11
K241460 — Manual WheelchairLichtmega Technology Co., Ltd.·Product code IOR·2024-07-11
K241706 — MicroMatrix® UBM ParticulateAcell, Inc.·Product code KGN·2024-07-11
K241711 — Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.·Product code LIT·2024-07-11
K241724 — Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.·Product code KGN·2024-07-11
K232177 — Lightin System, Lightin, Lightin GeneratorSolmedix Co., Ltd.·Product code SBS·2024-07-10
K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR KitLife Technologies Corporation·Product code QQX·2024-07-10
K233628 — AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc.·Product code JAQ·2024-07-10
K240016 — IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.·Product code OHT·2024-07-10
K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc.·Product code NEU·2024-07-10
K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB·Product code PFO·2024-07-10
K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) +2 moreMedtronic Perfusion Systems·Product code DTZ·2024-07-10
K241426 — GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.·Product code FMF·2024-07-10
K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation·Product code BZD·2024-07-10
K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (6+ models)Boston Scientific Corporation·Product code LIT·2024-07-10
K232551 — EM-07 Cordless Endo MotorForum Engineering Technologies (96) , Ltd.·Product code EKX·2024-07-09
K233937 — OW100SSoftwave/Trt, LLC·Product code PZL·2024-07-09
K240610 — deepLiveDamae Medical·Product code NQQ·2024-07-09
K240966 — Prima Plus Conical Implant SystemKeystone Dental, Inc.·Product code DZE·2024-07-09
K241019 — aprevo® TLIF-C Articulating SystemCarlsmed·Product code MAX·2024-07-09
K241316 — Zirconia BlockHunan Hualian Special Ceramics Co., Ltd.·Product code EIH·2024-07-09
K241343 — IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)Shenzhen Lescolton Electrical Appliance Co., Ltd.·Product code OHT·2024-07-09
K241372 — Advisor HD Grid X Mapping Catheter, Sensor EnabledABBOTT MEDICAL·Product code MTD·2024-07-09
K233584 — RhythmStar SystemRhythMedix, LLC·Product code QYX·2024-07-08
K240502 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.·Product code NAY·2024-07-08
K241293 — LED Light Therapy Device, ELIXIR MDYassen Wellness, LLC·Product code GEX·2024-07-08
K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 moreAdvanced Sterilization Products·Product code MLR·2024-07-05
K234084 — STERRAD Chemical Indicator (CI) Strip (14100) +5 moreAdvanced Sterilization Products, Inc.·Product code JOJ·2024-07-05
K240120 — Merlexi Craft Bariatric series of manual wheelchairsTurbo Wheelchair Co., Inc.·Product code IOR·2024-07-05
K240252 — UniCel DxH 900 Coulter Cellular Analysis System +2 moreBeckman Coulter, Inc.·Product code GKZ·2024-07-05
K241111 — AMT Suture PasserApplied Medical Technology, Inc.·Product code GCJ·2024-07-05
K241305 — LifeRay Intraoral Handheld X-ray SystemLucas Lifecare·Product code EHD·2024-07-05
K241625 — Anatase Navi Disposable InstrumentRemex Medical Corp.·Product code OLO·2024-07-05
K241649 — DUO1 and DUO2Zinnovi, Inc.·Product code MUH·2024-07-05
K241660 — SiOxD® Wound MatrixSioxmed, LLC·Product code QSZ·2024-07-05
K233574 — Total Wrist Arthroplasty System (TWA)Skeletal Dynamics·Product code JWJ·2024-07-03
K240009 — iQFlex ProFirst Source, Inc.·Product code IZL·2024-07-03
K240052 — Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.·Product code PIF·2024-07-03
K240946 — Gastric AlimetryAlimetry , Ltd.·Product code MYE·2024-07-03
K240987 — Access sTfRBeckman Coulter, Inc.·Product code DDG·2024-07-03
K240996 — Access Thyroglobulin Antibody IIBeckman Coulter, Inc.·Product code JNL·2024-07-03
K241129 — Upper Arm Electronic Blood Pressure MonitorShenzhen Goodlymed Technology Co., Ltd.·Product code DXN·2024-07-03
K241277 — OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.·Product code HWC·2024-07-03
K241284 — da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.·Product code NAY·2024-07-03
K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation·Product code FET·2024-07-03
K241508 — SKOUT® systemIterative Scopes, Inc.·Product code QNP·2024-07-03
K241577 — Iconix® AnchorRiverpoint Medical·Product code MBI·2024-07-03
K241591 — Blue EyeThe Standard Co., Ltd.·Product code PLL·2024-07-03
K241600 — DermablateAsclepion Laser Technologies GmbH·Product code GEX·2024-07-03
K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 moreStryker Sustainability Solutions·Product code NLQ·2024-07-03
K241615 — Transducer Probe CoverHony Medical Co., Ltd.·Product code ITX·2024-07-03
K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 moreEthicon Endo-Surgery, LLC·Product code GAG·2024-07-03
DEN240013 — MagDI SystemGt Metabolic Solutions, Inc.·Product code SAH·2024-07-02
K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) +2 moreOwens & Minor (O&M) Halyard, Inc.·Product code FXX·2024-07-02
K233415 — DELTAWAVE Nasal Pillows SystemRemsleep Holdings·Product code BZD·2024-07-02
K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH·Product code HGM·2024-07-02
K233626 — AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc.·Product code JAQ·2024-07-02
K234074 — Next Generation Access CatheterBalt USA, LLC·Product code QJP·2024-07-02
K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC·Product code NRY·2024-07-02
K240555 — Tyto Insights for Crackles DetectionTyto Care , Ltd.·Product code PHZ·2024-07-02
K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.·Product code ELC·2024-07-02
K240736 — SMART Bun-Yo-Matic X-RayDisior, Ltd.·Product code QIH·2024-07-02
K240863 — Freedom® Total Knee SystemMaxx Orthopedics, Inc.·Product code JWH·2024-07-02
K240915 — ZIEN IO Intraosseous Access SystemZien Medical Technologies, Inc.·Product code FMI·2024-07-02
K240930 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue +1 moreSri Trang Gloves Thailand (Public Company Limited)·Product code LZA·2024-07-02
K241300 — ViewPoint 6Ge Healthcare GmbH·Product code LLZ·2024-07-02
K241330 — Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences·Product code DXE·2024-07-02

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