FDA 510(k) clearances — page 43
clearances on record, most recent first.
Clearances — page 43
4,201–4,300 of 175,620- K243953 — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
- K250009 — LED Curing Light (C01-X, C02-X)
- K250058 — NEAT 001
- K250112 — FitboneTM Trochanteric
- K250177 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K250371 — cryoICE cryoXT cryoablation probe (cryoXT)
- K250389 — XNY Disposable Gastric Calibration Tube
- K250486 — Skyway Anterior Cervical Plate System
- K250754 — cmAngio® (V1.6)
- DEN240021 — Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
- K241589 — Ceribell Seizure Detection Software
- K242429 — CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System
- K243613 — Patch-TEA (Model TRI-21)
- K243743 — autoSCORE (V 2.0.0)
- K243819 — Luminopia
- K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
- K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- K250373 — ProLift Expandable Spacer System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K242151 — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
- K242295 — BunkerHill BMD
- K242552 — Horos Mobile
- K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
- K243722 — Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
- K243749 — Jmoon Conductive Gel
- K243967 — ONE Nitrile Condom
- K250136 — Globalcare Blood Pressure Monitor (GUS610)
- K250343 — LuxCreo Clear Aligner System
- K250366 — Electric Wheelchair (LW01301A07)
- K250708 — NPseal
- K250948 — TriMed Fusion Cup System
- K242385 — LED Therapy Mask (MN1, M226)
- K243143 — E-PEN (E-PEN)
- K243567 — Tyto Insights for Rhonchi Detection
- K250033 — Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
- K250395 — BioBrace ® RC Delivery System
- K250425 — Ultraviolet Phototherapy Device
- K250521 — NanoBone® SBX Putty ; NanoBone® QD
- DEN240031 — Prapela SVS hospital bassinet pad (model P01)
- K240398 — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
- K241982 — DeepFoqus (DeepFoqus-Accelerate)
- K242001 — Philips VSC-MEDlib
- K242068 — LED Light Therapy Mask (RT01)
- K242103 — TRIOS Ready Tip
- K242116 — EyeBOX EBX-4.1
- K242209 — UASure II Blood Uric Acid Monitoring System
- K242576 — AllTest Viral Transport Medium
- K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
- K242807 — HeartFocus (V.1.1.1)
- K243074 — Spectrum Spine Lumbar Cage System
- K243236 — WHOOP ECG (electrocardiogram) Feature (1.0)
- K243549 — JETi Hydrodynamic Thrombectomy System
- K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
- K243691 — LiquID .051 LP Guide Catheter Extension
- K243769 — QFR (3.0)
- K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
- K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
- K250332 — Virage® OCT Spinal Fixation System
- K250656 — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
- K250667 — DeGen Medical Patient Specific Implant (PSI) System
- K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
- K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
- K240615 — Leos Laser and Endoscopy System
- K242358 — Powered wheelchair (mobility robot) (M4, M4U)
- K242551 — syngo Dynamics (Version VA41D)
- K243298 — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
- K243305 — Masimo W1
- K243514 — Salvo® Robotic Navigation Instruments
- K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm
- K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
- K250658 — SureFine Pen Needle
- K241984 — Hi-D Imaging 4TAVR
- K242031 — Béa Applicator (BAP-GB-01)
- K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
- K242113 — Nerve Wrap (07-DW-001-TAB)
- K242114 — Plum Solo Precision IV Pump
- K242115 — Plum Duo Precision IV Pump
- K242117 — LifeShield Infusion Safety Software Suite
- K242460 — Progenix Select Stim
- K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
- K243733 — SION blue PLUS
- K243889 — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
- K250138 — Small Volume 0.2mL Syringe
- K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
- K250613 — SnapHammer Hammertoe Correction System
- K250677 — LEGION Total Knee System
- K250705 — Sonata Transcervical Fibroid Ablation System 2.2
- K250760 — SPECTRUM GV Bone Cement
- K250930 — twiist system
- K242041 — STOPWET iontophoresis apparatus (SW01)
- K242105 — SABA Tampons
- K242427 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K242925 — MR Contour DL
- K243072 — Préime DermaFacial (MicroT)
- K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
- K250018 — Medical Diode Laser Systems (THEIA808)
- K250189 — AdvaTx
- K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Data sourced from openFDA. This site is unofficial and independent of the FDA.