FDA 510(k) clearances — page 149
clearances on record, most recent first.
Clearances — page 149
14,801–14,900 of 175,699- K210830 — VUZE System
- K213068 — Medline Smoke Evacuation Shroud
- K213187 — Disposable Nitrile Medical Powder-free Glove
- K203177 — Sterisystem Dry-Base Instrument Tray
- K202898 — Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
- K211159 — eco-x Series (eco-x, eco-x-s)
- K211263 — Intrelief
- K211458 — Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
- K212547 — Quick-Start Screws
- K212834 — Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
- K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
- K211156 — CONVIVO In Vivo Pathology Suite
- K212656 — Flexible Intubation Video Endoscope Sterile (FIVE-S)
- K213073 — Goody Gloves, Wincare, TBG Gloves
- K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
- K213776 — LiverSmart
- K212806 — Alcon (serafilcon A) soft contact lenses for daily wear
- K213016 — ATM Glove
- K213209 — EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
- K193138 — Colibri System
- K212716 — Dermoaroma Disposable Nitrile Examination Glove
- K212848 — Sterile Latex Surgical Gloves Powder Free
- K213763 — Sonosite PX Ultrasound System
- K203523 — Fixone hybrid knotless anchor
- K211770 — R3ACT Stabilization System
- K202255 — Skypro, SP02 Mask (3)
- K212921 — Nitrile Examination Golves Powder Free
- K213136 — CPL Surgical Face Mask
- K193407 — Contour® next GEN Blood Glucose Monitoring System
- K202788 — Sonomed IV, Sonomed V
- K203714 — NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
- K210976 — Curian Campy
- K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)
- K212088 — Integrity Implants Navigated Instruments
- K212436 — NBR Synthetic Nitrile Examination Gloves
- K213208 — Twist Drills
- K213219 — Vy Spine VyWasher Buttress System
- K213479 — D²RS and D²RS 9090
- K213547 — SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
- K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
- K202404 — BoneMRI
- K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
- K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
- K210147 — Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
- K210305 — Pulse Oximeter
- K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1
- K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
- K211022 — Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
- K211691 — Ultrast Gel
- K212285 — Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
- K212310 — EyeBOX (Model EBX-4)
- K212397 — StealthStation S8 Cranial v2.0
- K212603 — Non Absorbable Surgical Nylon Suture
- K212767 — SleepRight Select-Comfort Dental Guard
- K212914 — Glovmaster Nitrile Examination Glove Powder Free
- K213024 — Oren LED Perioral Light Therapy System
- K213094 — ID-500 iRestore Hair Growth System
- K213140 — Claritas iPET
- K213144 — Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
- K213159 — Encore System
- K213207 — Sheath, Stopcock Accessory
- K213225 — Diode Laser System GP900A8, Diode Laser System GP900Q8
- K213411 — iSRobot Mona Lisa 2.0
- K213428 — EdgePro
- K213691 — Solas OR
- DEN210024 — CavaClear Laser Sheath
- K203343 — Wesper Lab
- K203660 — TRI-matrix Implant Line
- K210099 — Meticuly Patient-Specific Titanium Mesh Implant
- K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix
- K210670 — BU-CAD
- K210968 — reVive Light Therapy Essentials
- K211078 — Progreat Lambda
- K211086 — The Progen Trochanteric Nail System
- K211109 — N1 TiUltra TCC Implant System
- K211918 — iCOquit® Smokerlyzer®
- K212155 — TheraFace LED
- K212266 — FIX-C PEEK Anterior Cervical Interbody System
- K212613 — Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
- K212690 — qXR-BT
- K212730 — BellaTek Encode Emergence Healing Abutments
- K212770 — Vision
- K212830 — CT3000Pro
- K213006 — Vinyl Examination Gloves
- K213045 — TearCare System
- K213129 — Restoration Modular 115mm Conical Distal Stem
- K213139 — SURGmatic S15 L Pro
- K213301 — InCore Subtalar System
- K213456 — Xenco Medical Multilevel CerviKit
- K213596 — OSSIOfiber Compression Screw, 3.5mm
- K213705 — DRSplus
- K202568 — Mpact® 3D Metal Implants - DMLS Technology
- K203468 — TCAT TKA Instrument Tray
- K203741 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
- K211185 — IPL Home Use Hair Removal Device
- K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
- K211750 — Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
- K211842 — Servator M SALF Solution
- K211847 — AdVance XP Male Sling System
Data sourced from openFDA. This site is unofficial and independent of the FDA.