FDA 510(k) clearances — page 324
clearances on record, most recent first.
Clearances — page 324
32,301–32,400 of 176,542- K160130 — BloodSTOP iX Battle Matrix
- K160578 — Nustat XR
- K160752 — HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
- K160763 — ally Liquid Personal Lubricant
- K160770 — Vent-Os Sinus Dilation family
- K160878 — OPTIS Metallic Stent Optimization E.4 SW
- K160901 — Xpert Carba-R
- K161186 — Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
- K161285 — Ablation Confirmation
- K152350 — Regular and Special Umbilical Cord Clamp and Cutter
- K152606 — Jeesung Safety Syringe and Single Use Needles
- K153078 — LED Curing Light GT-2000
- K153312 — SCATTER CORRECTION FOR CXDI SERIES
- K153393 — PowerMidline Catheter
- K153739 — MRI Patient Monitor TeslaDUO
- K160584 — Surgical Navigation Advanced Platform (SNAP)
- K160697 — Gibralt® Spine System and Gibralt® Occipital Spine System
- K160820 — PressON Pro Spinal Fixation System
- K160874 — Nanovis Intervertebral Body Fusion System and FortiCore®
- K160911 — VIDAS B.R.A.H.M.S. PCT (PCT)
- K160916 — CoRoent® Ti-C System
- K160926 — F1 MPS Modular Pedicle Screw System
- K161024 — Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
- K161479 — hipEOS
- K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
- K160853 — Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
- K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
- K161482 — EndoChoice Water Bottle Cap Irrigation System
- K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
- K152339 — Unifine Pentips/ Unifine Pentips Plus
- K152585 — Resmon PRO FULL
- K152843 — Liger Medical HTU-110
- K153033 — Digital Blood Pressure Monitor
- K153201 — SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
- K153517 — AnyPlus® Cervical PEEK Cage System
- K153692 — Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
- K160430 — Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
- K160511 — Naya Breast Pump System
- K160523 — BrightMatter Guide with BrightMatter Pointer
- K160669 — ClariFix Device
- K160891 — Ultrathane Endoureterotomy Stent Set
- K161136 — Precision Treatment Planning System
- K161144 — iDMS Data Management System
- K161146 — Radixact Treatment Delivery System
- K161164 — CareEvent inclusive of the CareEvent Mobile Application accessory
- K161421 — Single Use Surgical Suction Irrigator
- K161476 — SMR Shoulder System
- K150404 — QiF Blood and Fluid Warmer
- K152600 — Collagen Dental Wound Dressings
- K152937 — EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
- K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
- K153018 — CELALUX 3
- K153057 — FitRite Total Hip Arthroplasty System
- K153353 — SANDMAN ELITE
- K153472 — Quiver Laparoscopic Extendable
- K153682 — Chocolate XD PTCA Balloon Catheter
- K160156 — StatStrip Xpress Blood Glucose Monitoring System
- K160169 — The Life Spine Subtalar Implant System
- K160468 — Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
- K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
- K160602 — JustRight Surgical Vessel Sealing System
- K160805 — NIO-P
- K160823 — NC Quantum Apex PTCA Dilatation Catheter
- K161191 — Latera Absorbable Nasal Implant
- K161559 — Kuvia3D
- K152863 — Portable ECG Monitor
- K152967 — NERBRIDGE
- K153545 — Portable Slit Lamp
- K153569 — Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
- K160514 — OptiCross 18, 30 MHz Peripheral Imaging Catheter
- K161061 — IMPAX Volume Viewing 4.0
- K161101 — PolypVac Microdebrider (3.3mm and 4.0mm)
- K161325 — CliniCloud Non-contact Thermometer, Model SPL1024
- K161429 — Target Detachable Coils
- K152246 — Aquarius Stoma Measuring Device
- K153106 — ASAHI Fielder XT-A, ASAHI Fielder XT-R
- K153225 — Masimo Root Monitoring System and Accessories
- K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
- K160131 — OEC Elite MiniView
- K160209 — Gold Anchor
- K160213 — s-Clean Tapered II RBM Implant System
- K160334 — Advanced Medical Imaging Software Suite (KSWVWR)
- K160691 — Acne Light Therapy Wand
- K161444 — DBSWIN and VistaEasy Imaging Software
- K152244 — RADspeed Pro
- K152884 — DermaTherapy Bed Linens
- K160170 — Lehman Manometry Catheter
- K160451 — V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
- K160458 — BI IMAGE-X EVOLUTION
- K160525 — RCT700
- K160598 — REBOA Balloon Catheter
- K161134 — Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator
- K152734 — Kerrison Rongeurs
- K152771 — SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
- K153351 — Quantib Brain 1
- K153367 — S698 Symbioz flow
- K153374 — CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
- K153537 — Sol-M Insulin Syringe, Sol-M TB Syringe
- K160265 — Image Navigator by Immuno Concepts
- K160544 — Withings Thermo (Model SCT01)
Data sourced from openFDA. This site is unofficial and independent of the FDA.