FDA 510(k) clearances — page 27
clearances on record, most recent first.
Clearances — page 27
2,601–2,700 of 176,479- K251988 — Boston iFace (Boston iFace)
- K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252913 — Break Wave
- K252962 — DYNAMIS Navigation System
- K253167 — Any-Paste
- K252842 — SafeOp 3: Neural Informatix System
- K251139 — KabiHelp® Uno; KabiHelp® Advance plus
- K251157 — Core Metabolic
- K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K252339 — iotaSOFT® Insertion System
- K252589 — Corvair Monza
- K252674 — Solo Pace Fusion System (SOLOFUSE1)
- K252847 — NextAR Hip Platform
- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K253075 — Mobility scooter (3 models)
- K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
- K253550 — Self-Forming Magnet (Flexagon Plus OTOLoc)
- K253957 — HemosIL Silica Clotting Time
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
- K254003 — JARVIS Metaphyseal Stem
- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K252585 — ZENEX Implant System_R-System
- K252669 — Fetal Doppler U8-25, U9-25
- K252711 — Advantage-C Ti3D Cervical Interbody Fusion Device
- K252759 — revyve® Antimicrobial Skin and Wound Cleanser
- K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- K252794 — Vision-MR Diagnostic Catheter
- K253266 — Titanium Interbody System
- K253370 — LOGIQ Totus
- K253512 — MiniMed Go App
- K253639 — View
- K253784 — 3DICOM MD Cloud
- K250305 — Reprocessed Agilis NxT Steerable Introducer
- K251207 — Sangria Thrombectomy System
- K251454 — Clear Aligner (SCF-3348)
- K252507 — SmileInspector
- K252727 — Neodent InLab Validated Workflow
- K252890 — ZenSeal Pro
- K252970 — BriefCase-Triage: CARE Multi-triage CT Body
- K253009 — DS Core Detect
- K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
- K253158 — VyBrate VBR System
- K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- K253366 — LOGIQ Fortis
- K253923 — PuraStat
- K253924 — PuraStat
- K253939 — DeltaWave Nasal Pillow System
- K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
- K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K250341 — Sensilift Pro (ST300XXYYZZZ)
- K251097 — V-DAC Catheter
- K251165 — Saans (F4-01-00-000-000)
- K252749 — Medconn 8K Glycated Hemoglobin Test System
- K252886 — Pen Needle
- K252894 — aprevo® cervical interbody system
- K253178 — TRILEAP Plating System
- K253618 — QuadLock Fixation System
- K253793 — Materialise TKA Guide System
- K251630 — Atellica IM Total PSA II (tPSAII)
- K251668 — SurfRider 13 Microcatheter
- K251757 — Puracyn® Plus Antimicrobial Irrigation Solution
- K252018 — HERA Z20 Diagnostic Ultrasound System +5 more
- K252650 — Disposable Medical Face Mask
- K252988 — ChartCheck (RADCH V1.6)
- K253008 — maiLink
- K251178 — Ready to use Nelaton Catheter
- K252817 — Mobility Scooter (BC-MS310)
- K253854 — MONTAGE XT Cranial Cement
- K253867 — FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
- K252901 — Tyber Medical Trauma Screw
- K252951 — Genesis Sleep
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
- K253888 — MOLLI 2 System
- K242492 — Multichem ID-G (09339892190) +5 more
- K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
- K251091 — Lipids
- K253532 — TruSPECT Processing Station
- K253844 — AnyScan 3.0 NM Scanner Family
- K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
- K251534 — Oxygen Concentrator (J10A)
- K253325 — ZipToe Hammertoe Fusion System
- K253343 — Celebrace Software
- K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- K253279 — Feather/numiere 05 06 07 (05)
- K253342 — PICO-K
- K253349 — Hair Regrowth Cap (Model: T-119-HRC)
- K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
- DEN250004 — QIKCAP System
- DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- K250476 — NizPlant Dental Implant System
- K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
- K251800 — Healgen® URS Test Strips
- K251958 — VEINOPLUS Back
Data sourced from openFDA. This site is unofficial and independent of the FDA.