FDA 510(k) clearances — page 51
clearances on record, most recent first.
Clearances — page 51
5,001–5,100 of 176,479- K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- K250499 — RELiZORB (100300/100301)
- K250829 — Lacevo Wearable Breast Pump (Model S70)
- K250889 — EXULT Knee Replacement System
- K241733 — HEBE (NP0000763)
- K242500 — LARALAB
- K242647 — MySegmenter (v2.0.0)
- K242806 — Medyssey Navigation System
- K243513 — DCM (PW-DCM)
- K243853 — Clarius Prostate AI
- K250809 — Stellar M22
- K250850 — Nanox.ARC X
- K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
- K242773 — Electro Lube NXT
- K242786 — TearCare MGX System
- K242932 — Skin Clinic Nitro Clear Wart Remover
- K243055 — Préime DermaFacial Collagen+
- K250212 — LapBox Power Tissue Containment System
- K250327 — OptaBlate Radiofrequency (RF) Generator System
- K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
- K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- K250824 — Percuflex Ureteral Stent +11 more
- K250833 — SwissMembrane X; SwissMembrane X Socket
- K243852 — Elfor-L
- K250094 — Atlas Stim Headbox (NK) (31-0601-0077) +9 more
- K250301 — Merge Universal Viewer (MUV)
- K250402 — AVAVA Skin Treatment System
- K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- K250823 — Any-Com Flow
- DEN240064 — CT-132
- K242098 — Cornaris Intravascular Imaging System (P80-E) +2 more
- K242120 — OTOPLAN
- K242600 — Second Opinion Periapical Radiolucency Contours
- K242646 — Dental Implant Unit
- K242748 — Oncospace
- K242772 — AirSurgN Insufflator (10030/AirSurgN)
- K243044 — Alma Harmony
- K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
- K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test
- K243356 — Asiga DentaBASE
- K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
- K243558 — Canvas Dx
- K243710 — Disposable ureteral access sheath
- K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
- K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System
- K243898 — Chlorine Sentinel II
- K243921 — LED Curing Lights (DB686 HALO)
- K250081 — Atlantis® Abutments in Titanium
- K250416 — GBrain MRI
- K250438 — CooperSurgical Milex® Pessaries
- K250748 — KLAXON (TWIST); KLAXON (TWIST R)
- K250811 — Dental Zirconia Ceramic
- K242045 — Initia T3 Acetabular Hemispherical Shell System
- K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
- K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
- K242928 — Tesera-k SC System
- K243145 — syngo.CT LVO Detection
- K243240 — Vitrea CT VScore
- K243943 — TriMed® Compression Screws
- 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) +4 more
- 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) +2 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.