FDA 510(k) clearances — page 18
clearances on record, most recent first.
Clearances — page 18
1,701–1,800 of 175,620- K251357 — Esperance pHLO Aspiration System
- K251458 — Electric Wheelchair (DH01168)
- K251831 — Bio-Medicus Life Support Catheter and Introducer
- K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- K251961 — SDS Growing Rod
- K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
- K252283 — Nano-Check Influenza A+B Test
- K252516 — N22 EZ Glenosphere
- K252567 — AltiVate Reverse® ADLC Glenosphere
- K252934 — Diagnocat
- K253023 — BIOGRAPH One
- K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
- K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
- K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
- K253925 — Aventus Thrombectomy System
- K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
- K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System
- K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP
- K251996 — ENTire IRE System
- K252219 — Cervical Interbody and VBR Fusion System
- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K252579 — Orthoscan TAU MVP Mini C-Arm System
- K252958 — METICULY Patient-specific titanium mesh implant
- K253511 — Concerto Versa Detachable Coil
- K253585 — SmartGuard technology; Predictive Low Glucose technology
- K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
- K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant
- K252461 — Swedge Pedicle Screw Fixation System Bezier Rod
- K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
- K253248 — Bright Cavity Liner
- K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
- K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K250890 — SBC1 Cream
- K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K251524 — Dr. Yglo Skin Tag Remover
- K251558 — Precision AI Surgical Planning System (PAI-SPS)
- K251701 — Star E900 Electric System
- K251886 — EmpowerRide NAVIGATOR
- 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 (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.