FDA 510(k) clearances — page 64
clearances on record, most recent first.
Clearances — page 64
6,301–6,400 of 176,479- 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) +1 more
- 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
- K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
- K241981 — Change Healthcare Stratus Imaging PACS
- K242018 — UbiqVue 2A Multi-parameter System (UX2550)
- K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
- K242420 — pNOVUS 21 Microcatheter
- K242430 — Power-Flex (3 models)
- K242502 — Aurelia Surgical Mask ASTM Level-3 (2130)
- K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
- K242791 — Electric wheelchair (KR-8807)
- K241575 — Straumann® Anatomic Healing Abutments XC (AHA)
- K243233 — esolution® Esophageal Retractor
- K240417 — ProFound Detection (V4.0)
- K240510 — Microdacyn Hydrogel
- K240794 — Frontier X Plus
- K241099 — Plasonic (Plasonic)
- K241342 — Hair Growth Comb (SZ-23,SZ-23A)
- K241364 — Hybrid Viewer (00859873006189)
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K241802 — Device 300397 Putty
- K242231 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
- K242286 — Superflow Prime Treatment System (ASP-1M)
- K242382 — décoLITE LED Device
- K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent
- K242756 — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
- K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
- K243004 — Xpine Spinal Fixation System
- K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
- K243231 — Trigon PEEK HA Wedges
- K212425 — MicroTrend System
- K240415 — Newclip Patient-matched instrumentation non sterile PSI
- K240429 — Trilogy Tissue Marker
- K240712 — icobrain aria
- K241346 — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
- K241468 — Vertiwedge® Intraosseous System
- K241719 — NeuroICH
- K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
- K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093)
- K242361 — OZARK Cervical Plate System +13 more
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K242373 — Mako Shoulder Application (1.0)
- K242379 — LL Implant System
Data sourced from openFDA. This site is unofficial and independent of the FDA.