FDA 510(k) clearances — page 55
clearances on record, most recent first.
Clearances — page 55
5,401–5,500 of 175,620- K242884 — Additively Manufactured Denture Resin
- K242913 — Jasmate® Toothpaste
- K242927 — Suction Irrigation Tubing Set
- K242968 — Giftlife® Single-Step Medium Plus
- K243334 — Nooro Body & Foot Stimulator (SM9141, SM9142)
- K232520 — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
- K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- K241157 — Secret MAX Multi-platform RF System
- K241210 — Luja Coude
- K241319 — SKR 3000
- K241495 — Jazz Classic
- K242414 — TiLink-P Joint Fusion System
- K242553 — MIRARI® Cold Plasma System ( GV-M2-01)
- K242596 — Versalock Mini and Micro Plating System
- K242799 — PliaFX Flo
- K242871 — ATTUNE Revision Hinge Knee
- K242874 — Gating Reflector Block
- K242998 — GMReis Ankle Plating System
- K243405 — Xpert vanA
- K232965 — Leg Massager (Models:RP-ALM070H, RP-ALM071H)
- K240716 — AETOS Shoulder System Stemless Humeral Prosthesis
- K240746 — Neurovascular Access System Family
- K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- K241603 — Powered Wheelchair (NXN20-208, NXN20-211)
- K241843 — TD-7301 Spirometer (TD-7301)
- K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
- K242359 — Strain AI (SAI001)
- K242363 — HIGHERDOSE Red Light Hat (HG-120K)
- K242517 — ProAM ACDF System
- K242520 — Element Vascular Access System
- K242521 — Estar-ZE
- K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
- K243164 — INDIBA COMPACT devices
- K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
- K242102 — CerroZone Mini
- K242293 — Medical Thulium Fiber Laser Systems (UroFiber 60Q)
- K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
- K242516 — EUROPA Posterior Cervical Fusion System
- K242523 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
- K242930 — Natus BrainWatch System
- K243045 — BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
- K243277 — Freedom® Medial Congruent Liner
- K243316 — XENOVIEW 3.0T Chest Coil
- K243323 — Iconix Knotless Anchor
- K240871 — Synxess Neurovascular Guidewire
- K241498 — Diode laser Treatment System (K18)
- K241633 — Informed Vital Core Application (IVC App)
- K241700 — Tenex 2nd Generation System
- K241747 — Saige-Dx
- K241814 — da Vinci SP Instruments (SP1098)
- K242092 — MICRO Arterial Filters
- K242329 — CT Collaboration Live
- K242402 — Power wheelchair
- K242471 — Power Wheelchair (W5538)
- K243320 — Air Pressure Therapy System (VU-IPC04B)
- K243506 — Montage-XT Settable Bone Putty
- K233081 — NUVENTUS NV.C Dental Implant System
- K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- K240528 — b-ONE® Total Hip System
- K240860 — EchoGo Amyloidosis (1.0)
- K241070 — Gelsoft Plus Vascular Prostheses
- K241125 — VIVIX-S 1751S
- K241138 — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K241439 — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
- K242062 — 1CMR Pro
- K242130 — Koios DS
- K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
- K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
- K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
- K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- K242800 — The 5000 Compact Series Ultrasound Systems
- K242960 — AdVance XP Male Sling System (720163-03)
- K243285 — TMINI Miniature Robotic System
- K243299 — ACUSON Redwood Diagnostic Ultrasound System
- K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
- K241339 — Besmed Bacterial Filter and HMEF
- K241397 — Hinscope
- K241930 — Veincare
- K242079 — Arthrex Elbow Fracture Plating System
- K242342 — Fetal EchoScan
- K242436 — Proximal Humerus Fixation System
- K242440 — Intense Pulsed Light Treatment System (LK-PT)
- K242598 — DEFINE System (AG612444A)
- K242814 — Tandry Q-Locking Plate System
- K242940 — Xrecovery (XR-001)
- DEN240023 — SmartFlow Neuro Cannula
- K211498 — Nonin OTC Pulse Oximeter Model 3250
- K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
- K241135 — RESPOND(R) Ventilator
- K242407 — Dental Glass Ceramics Blocks (HT, LT, MT)
- K242764 — MediRod Pedicle Screw System
- K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- K243273 — CeQur Simplicity On-Demand Insulin Delivery System
- DEN230085 — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
- K230915 — AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
- K240771 — PRORAD X-Ray Flat Panel Detector with DROC
Data sourced from openFDA. This site is unofficial and independent of the FDA.