FDA 510(k) clearances — page 28
clearances on record, most recent first.
Clearances — page 28
2,701–2,800 of 176,479- K251978 — LIAISON NES FLU A/B, RSV & COVID-19
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K252145 — GEN5 and GEN5+ 3.3mmD Dental Implants
- K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K252187 — Aura Glide (FC40)
- K252379 — AIR Recon DL
- K252493 — NOVEOS Specific IgE (sIgE) +4 more
- K252633 — UNITY DX (UDX)
- K252835 — Electric Scooter (S202572J, S2060, M2089, S2050)
- K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
- K253091 — ART-Plan+ (v3.1.0)
- K253122 — Sim&Size
- K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
- K253217 — MiiS Horus Arthroscope (EJA 100) +2 more
- K253239 — Active-V Total Knee System; World Total Knee System
- K253281 — UpDoc
- K253312 — OrangeCAD Med Abutments
- K253341 — Custom Abutments AS
- K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K253675 — OsteoRemedies Hip Spacer System
- K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- K253754 — Philips Lumea IPL
- K254163 — VarioSurg 4
- K243342 — KP Protective Face Mask
- K250756 — Pression Wave PRO External Counter-Pulsation System
- K250959 — BioticsAI
- K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
- K251105 — Tetra (TM-20); Tetra (TM-50)
- K251159 — Power wheelchair
- K251605 — DIMPLO Implant System
- K251764 — Oxygen Concentrator-P2-O5E
- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K252068 — MC2 Portable X-ray System
- K252109 — RayStation (2024A SP3)
- K252361 — AccurECG Analysis System (v2.0)
- K252557 — Lumify Diagnostic Ultrasound System
- K252611 — aprevo® cervical plating system
- K252616 — Portable oxygen concentrator (JLO-190P)
- K252673 — LacertaMatrix
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K252856 — PeekMed web
- K252981 — EmbraceMini
- K253222 — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
- K253339 — Theracor
- K253661 — TMINI Miniature Robotic System
- K253664 — SKOUT system
- K253727 — Syndesmosis TightRope PRO
- K253769 — Instylla Delivery Kit
- K253781 — InnoClip Clip Applier
- K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
- K253903 — InnoClip Disposable Clip Applier
- K232365 — Vivo 45 LS
- K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- K250864 — MatriDerm pluS+ Bi-Layer
- K250976 — Airbile-100
- K250998 — CO2 Laser Therapy System (Model: LFS-D9U)
- K251011 — Chiavaye Personal Moisturizer
- K251037 — Rectal Applicator
- K251050 — Pectus Versa System
- K251074 — Tru Liver Health Test Panel
- K251077 — JOULE 1064nm System and Accessories
- K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
- K251152 — DBLG2
- K251402 — LIA-1 Catheter (542-1)
- K251469 — Endura Ureteral Stent and Stent Set
- K251572 — eRapid with eTrack System
- K251730 — LIA Console (542-7)
- K251751 — Spo2 Sensor CSS032D
- K252029 — AI-CVD
- K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- K252284 — eMurmur Heart AI
- K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
- K252480 — CE Deliver (DLV)
- K252670 — Alzevita
- K252754 — Wearable Electric Breast Pump (YM-8803)
- K252780 — LCD Monitor (CL1902A, CL2103F)
- K252781 — MSFX MIKRON PEEK CAGES
- K252838 — MAGNETOM Sola +9 more
- K252863 — ClearCalc Model RADCA V2.6
- K252877 — SANDRO Dual
- K252892 — SCOUT MD Surgical Guidance System
- K252974 — EMPOWR Knee
- K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
- K253086 — LED Light Therapy Device (Models: SG-FM, SG-FE)
- K253161 — Balanced Knee System TriMax Porous Femoral Components
- K253202 — Hoffmann LRF System
- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K253373 — Southern Craniomaxillofacial (CMF) System
- K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
- K253613 — Monkey Rings External Ring Fixation System
- K253616 — ProtekDilate Vascular Access Kit
- K253733 — STAR Apollo Mapping System
- K254063 — iCEM Universal Plus
- K250914 — MediAI-BA
- K250993 — Single Use Cytology Brush V (BC-V600P-3010)
- K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)
- K251915 — Amethyst HP PTA OTW 0.035 Catheter
- K252071 — RefleXion Medical Radiotherapy System, Reflexion X2
Data sourced from openFDA. This site is unofficial and independent of the FDA.