FDA 510(k) clearances — page 115
clearances on record, most recent first.
Clearances — page 115
11,401–11,500 of 175,620- K223250 — Disposable Nitrile Examination Glove
- K223503 — Access 25(OH) Vitamin D Total
- K223540 — AvalancheLase Family
- K223872 — Low Profile Companion Sheath
- K211759 — Selux AST System; Model AST Gen 1.0
- K213597 — MultiCut Solo
- K221088 — Anatomic Bone Plate
- K221726 — Uni-FuZe-C Bone Strip
- K222000 — Transit-Pellets
- K222593 — TruPlan Computed Tomography (CT) Imaging Software
- K223107 — MOLLI 2
- K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- K223804 — PercuNav Image Fusion and Interventional Navigation System
- K223819 — SI-Cure Sacroiliac Joint Fusion System
- K213655 — HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
- K220649 — Elucis
- K220884 — Disposable Endoscope Valve Sets
- K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
- K222941 — Halcyon, Ethos Radiotherapy System
- K223010 — Portable X-ray System
- K223222 — Plasma IQ
- K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- K223795 — FairFix QT Adjustable Button
- K223800 — MIM Additional Tracers
- K213514 — Spectricept Skin and Wound Cleanser
- K214078 — Silkn Toothwave
- K220495 — SignaSure Dual Mobility System
- K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
- K221252 — Scivita 4KINSIGHT ICG Imaging System
- K221317 — S-Mono
- K221542 — Galileo Vertebral Body Replacement Device
- K221682 — Ideal Med Pro 3-Ply Disposable Face Mask
- K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
- K221933 — MONTAGE Settable, Resorbable Bone Putty
- K222170 — Power Acute Triple Lumen Hemodialysis Catheter
- K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K222782 — Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
- K222913 — s-Clean Link Abutment
- K223031 — Vibrant System
- K223183 — Light-Guide Cables
- K223221 — Non-Sterile Powder Free Nitrile Examination Gloves
- K223405 — Access Testosterone
- K223429 — Contour Knee
- K223474 — PathLoc-TA Expandable Lumbar Cage System
- K223480 — Medipoint Blood Lancets
- K223502 — MR Diffusion Perfusion Mismatch V1.0
- K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- K223748 — Nitrile Exam Gloves (Chemotherapy Drug Tested)
- K221774 — Garmin ECG App
- K221873 — NeoGen PSR System
- K222011 — HandX Instrument - Monopolar Spatula
- K222150 — PreXion3D Expedition
- K222458 — AIBOLIT 3D+
- K222830 — Rainbow 360
- K222976 — MU System
- K223363 — MAMMOVISTA B.smart (VB70)
- K223644 — Neuronaute with IceCap 2 & IceCap 2 Small
- K223731 — NuVasive Modulus-C Interbody System
- K223782 — Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
- K191111 — DD Solid Connect® CAD/CAM Abutments
- K221278 — Transducer Probe Cover
- K222181 — Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
- K223000 — Artix BG
- K223181 — NuVasive Reline System
- K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
- K223465 — RadianceTx Radionuclide Brachytherapy Source
- K223719 — Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
- K223738 — Alpha Control Liner System (ACLS)
- K223764 — INFINITY OCT System
- K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) System
- K211047 — CoCr Head
- K221090 — Metal Cannulated Screw
- K222115 — ISAAC Neurovascular Navigation Catheter
- K222799 — Haymaker® Screw System
- K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV
- K222711 — HS186B Scooter
- K222787 — Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
- K222789 — VADER® Pedicle System, G21 Cement
- K223336 — Vitrea Software Package, VSTP-002A
- K223789 — 21HQ513D
- K203380 — Disposable Surgical Face Mask
- K211812 — BLUEDIAMOND IMPLANT, Abutment Screw
- K213423 — T3 Platform software
- K221260 — CSF-3
- K222296 — ARTICUL/EZE Ceramic Heads
- K222577 — TECHFIT Diagnostic Models
- K223200 — Curiteva Navigation System
- K223412 — LumiVy Lumbar IBF System
- K223675 — WatchPAT ONE (WP1)
- K223749 — U by Kotex® Click® Unscented Menstrual Tampons
- K213198 — Ax-Surgi Surgical Hemostat
- K221149 — U-Motion II Acetabular System-Extension line
- K221181 — Treace Medical Concepts (TMC) Plating System
- K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device
- K222834 — Safety Push Button Blood Collection Set
- K223650 — REMEDY Stemmed Knee Spacer
- K223671 — CONDUIT LLIF Straight Inserters
- K213263 — OnyxCeph
- K221125 — SilentCloud
- K221379 — Steriking LT-Blueline Pouches with Tyvek
Data sourced from openFDA. This site is unofficial and independent of the FDA.