FDA 510(k) clearances — page 141
clearances on record, most recent first.
Clearances — page 141
14,001–14,100 of 175,699- K212274 — INT Contour
- K212309 — Non-sterile, Powder-Free Latex Examination Glove
- K212372 — Fitbit Irregular Rhythm Notifications
- K212882 — SCOUT BX Delivery System
- K213015 — DORA Disposable A.V. Fistula Needle Sets
- K213063 — TLX SRAs and TLX Gold Abutments
- K213509 — Latex Examination Gloves, Powder Free
- K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
- K213958 — Bioabsorbable Anchor
- K220144 — Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
- K220192 — Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
- K220490 — ImaCor Zura Handheld ZHH-010
- K220699 — Prestige Coil System
- K220724 — CD Horizon Spinal System and PASS LP Spinal System
- K220809 — Drive Rail System
- K210860 — Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
- K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer
- K212069 — Corin MetaFix Hip Stem
- K212203 — Dong Hai Xiang Surgical Mask
- K212278 — Electrocardiograph
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.