FDA 510(k) clearances — page 52
clearances on record, most recent first.
Clearances — page 52
5,101–5,200 of 176,479- 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) +7 more
- K250011 — Turbett Surgical Instrument Pod (3 models)
- 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 +5 more
- 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 (3 models)
- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch +4 more
- 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 +2 more
- 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 (4 models)
- K250138 — Small Volume 0.2mL Syringe
- K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02 +3 more
- 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 +4 more
- K250018 — Medical Diode Laser Systems (THEIA808)
- K250189 — AdvaTx
- K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
- K242166 — TribusConnect
- K243178 — Digital Color Doppler Ultrasound Imaging System (8+ models)
- K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001)
- K250263 — Disposable Grasping Forceps FG-52D/FG-54D
- K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- K250946 — Denture Base Resin DT20
- K242618 — Layer 7-T
- K250601 — Neuro Omega System; NeuroSmart System
- DEN240020 — Visby Medical Women's Sexual Health Test
- K233953 — Makani Science Respiration Monitoring System
- K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
- K241927 — Synthes Graphic Case & Tray System
- K242022 — Access Toxo IgG
- K242952 — INNOVANCE Antithrombin
- K243228 — Flexi-Seal AIR (with ENFit Connector)
- K243520 — Bullsai Confirm
- K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
- K244044 — PBC Separator with Selux AST System
- K250571 — CATALYSTEM Femoral Stems
- K250596 — Arthrex FiberTak Suture Anchor
- K241785 — StarFormer (M008-3T)
- K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48)
- K241962 — Crossloop
- K242201 — HyperSuture White/Green Extension Line
- K242745 — AI-Rad Companion Organs RT
- K242919 — V5med Lung AI
- K243038 — Salix Central
- K243426 — Nurochek-Pro System
- K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more
- K243768 — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
- K244046 — Edwards eSheath Optima introducer set
- K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more
- K250092 — HC Biologics Osteopoint Spinal Fixation System
- K250555 — MallyaD injection pen adapter (MallyaD)
- K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
- K240189 — NM-01/CPT neurometer (NM-01/CPT)
- K241855 — SB Knife Jr2 (MD-47702 and MD-47702L)
- K242669 — SnapshotGLO (KB100)
- K243831 — Rayvolve LN
- K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
Data sourced from openFDA. This site is unofficial and independent of the FDA.