FDA 510(k) clearances — page 238
clearances on record, most recent first.
Clearances — page 238
23,701–23,800 of 176,542- K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
- K190369 — M-Y Sheath
- K190688 — VersaCross Steerable Sheath, VersaCross Transseptal Dilator
- K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor
- K190728 — Arthrex SwiveLock Anchors
- K181541 — Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
- K182217 — Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
- K182246 — MIST IC
- K182999 — General Cutting Contra Handpiece
- K183302 — KY Banksy Aloe
- K183332 — BRAXX Esophageal Brachytherapy Applicator
- K183428 — Avulsion Forceps
- K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- K190773 — Elecsys TSH
- K181673 — Rigi10 Malleable Penile Prosthesis
- K181844 — One Touch
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
- K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- K182924 — Diode Laser Treatment System
- K183548 — SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
- K190072 — BriefCase
- K190320 — PreXion3D Explorer
- K190420 — NDOHD High Definition Imaging System (NDOHD)
- K190705 — WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
- K190690 — INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
- DEN180060 — Plenity
- K180757 — D-Clip; D-Clip Applier
- K181912 — Ascent Cardiorespiratory Diagnostic Software
- K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K182396 — KardiaMobile, KardiaStation
- K182572 — InstaRISPACS / InstaZFP / InstaMobi v5.0
- K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K182640 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
- K182737 — 3T 32 Channel Head Coil
- K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
- K183015 — PuraSinus
- K183202 — Deep Learning Image Reconstruction
- K183490 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
- K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
- K190079 — ArgenZ HT+
- K190365 — Baby Gorilla/Gorilla Plating System
- K190626 — SyncVision System
- K190658 — MIS Bunion Plating System
- K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K181296 — Syntec Femoral Nail System
- K181361 — Brux Night Guard
- K181758 — ELRA Electrode
- K183398 — Endoform Restella
- K183526 — Codman Electrosurgical Generator, Foot Pedal
- K190058 — PureSleep (OTC use)
- K190070 — Sonopet iQ Ultrasonic Aspirator System
- K190317 — Zavation Spinal System
- K190453 — VisCalor bulk
- K190786 — Eye Prime
- K181110 — PROPHYflex 4
- K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator
- K182662 — NAV PAK Needle, NIM NAV PAK Needle
- K183057 — PUMA-G System
- K183306 — GLUCOCARD® W onyx Blood Glucose Monitoring System
- K190175 — S-MAK XL
- K190295 — Confirm Rx Insertable Cardiac Monitor
- K190631 — M.U.S.T. MINI Posterior Cervical Screws System
- K181832 — Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
- K182333 — Vera
- K182341 — Pantheris SV
- K182770 — Adult Intraosseous Infusion Device
- K183660 — DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
- K190327 — ENConnect 40 mm Screw Cap to ENPlus Adapter
- K190653 — ExcelsiusGPS
- K182375 — CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
- K183204 — Bone VCAR (BVCAR)
- K183496 — JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
- K183539 — Ergoline Sunrise 7200 Hybrid Technology
- K183550 — Vitality® Spinal Fixation System
- K183606 — Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
- K183682 — OIC External Fixation System
- K190040 — Straumann BLX Line Extension - New Abutments
- K190611 — VIVIX-S 1751S
- K182287 — MEDINAUT Plus
- K173770 — OJR215 Pressure Relief Manifold
- K181919 — Patient Monitor
- K182175 — TCD-X
- K182268 — EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
- K183287 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +2 more
- K183361 — EkoSonic Endovascular Device with Control Unit 4.0
- K183494 — R190/R191 LCD Monitor
- K190038 — Xbody Newave USA
- K190103 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
- K190581 — Amplatzer Trevisio Intravascular Delivery System
- K190598 — CROSSWAY Spinal Access System
- K173238 — ToxCO
- K180843 — HIgH-Flo Super26 Subcutaneous Needle Sets
- K181931 — GMC Upper Arm Automatic Blood Pressure Monitor
- K182253 — FUJIFILM Video Bronchoscopes
- K182399 — Park Blade Septostomy Catheter
- K182943 — VERTEX Nitinol Staple System
- K183197 — PYRAMESH Implant System
- K183304 — Prettau, ICE, Z-White zirconia blanks
- K183377 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
- K183445 — Erbe APCapplicators
Data sourced from openFDA. This site is unofficial and independent of the FDA.