FDA 510(k) clearances — page 222
clearances on record, most recent first.
Clearances — page 222
22,101–22,200 of 176,542- K192824 — Parcus Knotless AP Suture Anchors
- K181993 — STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
- K183018 — VPro5
- K190119 — Foryou NPWT Dressing Kit
- K190189 — MDT2 BLE Self-Monitoring Blood Glucose System
- K190190 — WV1 Endoscope
- K190334 — MIMOSA Imager
- K190344 — DePuy Corail AMT Hip Prosthesis
- K190544 — XIHPOS ZFUZE Interbody Fusion System
- K190855 — BD Acute Central Line
- K190898 — Sight OLO
- K191016 — COPAL exchange G Hip and Knee Spacers
- K191312 — Perfect PFE
- K191497 — NextDent Denture 3D+
- K191597 — Stealth Autoguide System, Midas Rex Legend Depth Stop System
- K191622 — Delta Multihole TT Pro Acetabular System
- K191631 — ZMAXX Dental Zirconia Blanks
- K191650 — LEGION System
- K191693 — BC-5
- K192087 — Combo Electrotherapy Device
- K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera
- K192117 — Small VBR
- K192278 — Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
- K192440 — FDR SE Lite
- K183412 — mediCAD Web
- K190047 — StimRouter Neuromodulation System
- K190281 — Ultrasonic Surgical System
- K190747 — Claritag
- K191002 — OR3O Dual Mobility System
- K191769 — ePM Series Patient monitors
- K191896 — Belimed Steam Sterilizer MST-H TOP 5000
- K192110 — Vitek Densichek
- K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
- K192525 — 087 Balloon Guide Catheter System
- K192743 — VisionX 2.4
- K192867 — Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
- K192961 — ADH19
- K190267 — EZE SIT Valvulotome
- K190921 — Arthrex Low Profile Screws
- K191134 — IB3D ALIF
- K191170 — Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
- K191264 — Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)
- K192083 — Okami Medical LOBO Vascular Occlusion System
- K192504 — Treace Medical Concepts (TMC) Plating System
- K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
- K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile +2 more
- K192790 — Atellica IM Total hCG (ThCG)
- K191385 — BRILLIANT COMPONEER
- K191855 — EmFace Device
- K191862 — Compression Therapy Device Model LGT-2200SP
- K191925 — MATRx Plus
- K192041 — G21 SpaceFlex Hip
- K192053 — W Zirconia Implants
- K192114 — Game Ready GRPro 2.1 System
- K192121 — Black Diamond Pedicle Screw System
- K192133 — Zimmer Biomet Universal Navigation System
- K192173 — ROSA ONE Spine application
- K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K192494 — NexGen Anterior Cervical Plate System
- K180347 — 3d Cage
- K182605 — HS AMICA devices family
- K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
- K192029 — Straumann PUREloc abutments
- K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- K192673 — 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K192802 — primeMidline Catheters
- K190624 — EarlyVue VS30
- K190181 — Instruments for LINK MEGASYSTEM-C Family
- K190221 — IOB Warming Blankets
- K190847 — REDAPT Blade Augments
- K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
- K191085 — Maverick RNP Assay and Maverick Diagnostic System
- K191470 — C-CAT Anaesthesia Catheter kit
- K191563 — FILTRAY 2G Disposable Water Filters
- K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
- K191874 — F5 Corpus VS
- K192360 — IntellaMap Orion High Resolution Mapping Catheter
- K192518 — Reusable Monopolar Active Cord
- K192667 — gel-e Flex+ gel OTC
- K192705 — MiniCap Extended Life PD Transfer Sets
- K192725 — Cytal Wound Matrix 3-Layer
- K192787 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
- K181660 — Acapella Choice Blue Vibratory PEP Device
- K190037 — Cronus HP PTA Balloon Catheter
- K190210 — Tear Pool Dissolvable Punctum Plugs
- K190349 — MediExpand TL Expandable VBR System
- K190426 — ALTA Anterior Cervical Corpectomy System
- K190556 — Zimmer Biomet Universal Navigation System
- K190632 — Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
- K191358 — Trident II Acetabular System
- K191812 — ADI Cervical Interbody Fusion Device
- K191944 — MU2net
- K192678 — Genesys Spine Binary® Lumbar Plate System
- K192686 — Revolution Maxima, Revolution Ace
- K192690 — Upgrade Kit MR GUI PRO, MrJ 3300 Plus
- K192722 — Padlock Clip defect closure system, Padlock Pro-Select defect closure device
- K192728 — Agnes
- K182743 — Patient-Specific Airway Stent
- K183562 — Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
- K190157 — Diana ChemoClave Transfer Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.