FDA 510(k) clearances — page 149
clearances on record, most recent first.
Clearances — page 149
14,801–14,900 of 176,479- K220287 — Invisalign System
- K202106 — Plasmage System
- K202534 — MTM301 Blood Glucose and Ketone Monitoring System
- K203783 — ClariPulmo
- K210593 — Onera Sleep Test System (Onera STS)
- K210714 — Extended Reservoir
- K213506 — NB 1 SA Implant System
- K213578 — Balloon Dilatation Catheter
- K213809 — 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
- K214085 — Disposable Medical Mask
- K214114 — Prodigy Thrombectomy System
- K220625 — ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
- K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
- K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
- K212463 — Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
- K212601 — DRPx Locking Distal Radius Plate System
- K213011 — Infrared Thermometer (model: E201)
- K213450 — Medical surgical mask (Black mask, Level 1 and Level 3)
- K213560 — Verifine Safety Syringe with Fixed Needle
- K213746 — Digital thermometer, Model DT101, DT102
- K213783 — Apyx
- K213808 — Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
- K214081 — MRCAT Head & Neck
- K220043 — HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
- K220335 — Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
- K220364 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K212126 — MediExpand Cervical Expandable VBR System
- K212624 — EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
- K213282 — ERI Handheld Dental X-ray System (Model AG100)
- K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
- K214006 — Invictus® Spinal Fixation System
- K220022 — TRATE Dental Implant System
- K213604 — ELAZ Nitrile Powder Free Examination Glove
- K220066 — Medical Nitrile Examination Gloves
- K212947 — Trinity Plus Wrinkle Reducer
- K220343 — Nitrile Examination Gloves
- K210052 — Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
- K210558 — LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
- K211882 — HD-550 Video Endoscope System
- K212184 — TENS and EMS Stimulation (OTC)
- K212216 — Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
- K212392 — Intri24 Sheath
- K213118 — Dakota ALIF System
- K213432 — MIS Angulated multi-unit abutments
- K213490 — Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
- K213494 — Aveir Retrieval Catheter
- K213552 — PuraStat-RM
- K213657 — DEEPVESSEL FFR
- K213793 — EMPOWR Revision Knee
- K220005 — TENS & PMS Unit
- K220151 — MAGNETOM Avanto Fit
- K220518 — SKANRAD 400
- K220601 — CoolTone
- K220668 — Wireless Digital Flat Panel Detector
- K210546 — Elecsys proBNP II, Elecsys proBNP II STAT
- K211043 — Alexis Contained Extraction System
- K211120 — ERIC Retrieval Device
- K212888 — Golnit Nylon Monofilament Suture
- K212894 — PhasTIPP
- K213736 — Medical Face Mask
- K213745 — Air Compression Therapy Device, model: ST-502
- K213843 — Nitrile Examination Gloves
- K214057 — STATIM 6000B Vacuum Autoclave
- K220025 — ARx® Spinal System
- K220160 — PediGuard Threaded
- K220202 — Uterine ElevatOR PRO with OccludOR Balloon
- K220240 — Vinyl Co-Polymer Powder-free Examination Gloves, Black
- K220260 — Hercules Syndesmosis Implant System
- K220291 — NEXXT SPINE NAVIGATION System
- K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
- K220584 — BD Cathena Safety IV Catheter
- K220674 — TargetCool
- K220678 — APX-24 Portable X-ray System
- K210422 — INTAI Surgical Mask (non-sterile)
- K211681 — EON
- K212159 — Shield System
- K212464 — Dukal Corporation AAMI Level 4 Open-Back Protective Gown
- K213370 — VERIQA
- K213699 — CareTaker Monitor App
- K213896 — BD Trek Powered Bone Biopsy System
- K214047 — EL CAPITAN Anterior Lumbar Interbody Fusion System
- K214093 — VSP Bolus
- K220182 — Aggeris-C
- K220213 — Empulse R90
- DEN200042 — BrainTemp Neonate System (BTNeo System)
- K202266 — Reliance Cervical IBF System
- K210321 — Dukal Corporation Level 1 Pediatric Face Mask
- K213529 — Focus HD 43 Detector
- K213646 — Focus HD 35 Detector
- K213887 — GAL-1A Plus Blood Glucose Monitoring System
- K220247 — Guidewire Locking Device
- K220255 — REAL INTELLIGENCE CORI
- K212037 — SancDam Latex Oral Dam
- K212889 — Syngo.CT Dual Energy
- K213147 — CERABIEN MiLai
- K213415 — OSSIOfiber Suture Anchor
- K213662 — Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
- K213672 — T3 Pro Implants
- K214113 — Hand-held IPL device(JOVS Graphene Hair Removal Device)
- K210352 — GGM Breathing Circuit Bacterial Filter
Data sourced from openFDA. This site is unofficial and independent of the FDA.