FDA 510(k) clearances — page 156
clearances on record, most recent first.
Clearances — page 156
15,501–15,600 of 175,699- K212636 — CORUS Spinal System-X
- K212959 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K212967 — AxTiHA Stand-Alone ALIF System
- K202688 — AFS Medical Sterile Single-Use Access Port System
- K202808 — Brainance MD
- K210231 — Vittra APS Unique
- K210999 — SwiftMR
- K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
- K211147 — ALGO 7i
- K211214 — Sterile Hypodermic Needles for Single Use
- K211461 — Family of Venus RF Systems - Venus Freedom
- K211753 — Sterile Syringe With Safety Needle
- K211807 — Sapphire NC 24
- K211914 — Nitrile Patient Examination Gloves
- K212205 — Medical Protective Masks
- K212261 — StrokeSENS LVO
- K213002 — SCORPION Portal Vein Access Set
- K210116 — Video Endoscopy System, 3D Video Endoscopy System
- K211374 — Proclean - Nitrile Powder Free Examination Gloves
- K211801 — SPRINT PNS System
- K211905 — UltraCal XS
- K212014 — Medical Nitrile Examination Gloves
- K212544 — MiniLoad Syringe
- K212825 — CoreLink Navigation Instruments
- K212908 — EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
- K210845 — Disposable Surgical Mask (Model: YYKZ-01)
- K211927 — Nitrile examination gloves
- K212116 — VBrain-OAR
- K212307 — BC Reflex Uni Knee System
- K212552 — Correx Software
- K212560 — Signature ONE System
- K212562 — Idys-C ZP 3DTi
- K201514 — Child Face Mask
- K203750 — Straumann CARES P-Series CAD/CAM System
- K212174 — STERRAD 100NX Sterilizer with ALLClear Technology
- K201210 — The Micro Screw System, Micro Screw System Basic
- K201989 — B4C System
- K203497 — Infrared Thermometer (Model K9)
- K203688 — Clear Aligner
- K210128 — INTEGRA Wound Matrix (Macro-Channels)
- K210211 — PuraStat-OM
- K210622 — Single-Use Medical Face Mask
- K210813 — Medical Surgical Mask
- K211680 — Streamline Surgical System
- K211706 — Esophageal TTS Stent
- K212078 — Medical Examination Gloves
- K212156 — ABCcolla Bone Matrix
- K212479 — Cohitech Reusable Tampon Applicator
- K212520 — ProLift Micro Expandable Spacer System
- K212876 — Carescape SpO2 - Masimo
- K210024 — NeoMatriX Wound Matrix
- K210376 — Superior Hair Remover
- K210906 — IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
- K211077 — Surgical Gown
- K211211 — Sterile syringes for single use with/without needle
- K211406 — OASIS MRI System
- K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
- K212279 — Digital Intraoral X-ray Imaging System
- K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
- K202063 — TrusFIL Universal Composite Restorative
- K211621 — Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
- K211719 — ZinRom Nitrile examination gloves
- K212082 — Picore
- K212191 — Adhesive Electrodes
- K212739 — ActiFlip
- K212835 — AquaBeam Robotic System
- K201394 — CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
- K201456 — Scan Monitor
- K203002 — SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
- K203288 — Cala Trio
- K210406 — Bipolar Coagulation Foreceps
- K210490 — ChM 4.5mm Cortical screws
- K211429 — NAVIPLAN - CT Planning Software for Total Hip Replacement
- K211475 — Vital Signs Monitors
- K211508 — Steinmann Pins and Kirschner Wires
- K211728 — Sterile hypodermic syringes for single use
- K212036 — Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
- K212233 — RTHawk, HeartVista Cardiac Package
- K200558 — Smart Neck Stimulator
- K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
- K211308 — INNI-CERA
- K211368 — IPL Hair Remover, Model: G993, G996, G998 and G885
- K211405 — Prelude Guide Sheath
- K211425 — Private Stock Labs Surgical Face Mask
- K211745 — RecoveryAir PRO
- K211795 — EzDent-i/ E2/ Prora View/ Smart M Viewer
- K211899 — Surgical Face Mask
- K212135 — Dry DBM- A Putty
- K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
- K202927 — EYE-SYNC
- DEN190055 — iotaSOFT Insertion System - Drive Unit, Controller and Accessories
- K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
- K201934 — Surgimatix Absorbable Fixation System
- K210002 — STELLA BIO
- K210139 — Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
- K210140 — electrocardiograph: SE-1202
- K210270 — Medical Endoscope Image Processing System
- K210562 — HRSpheres Narrow-Size Embolic Microspheres
- K211221 — Porous Patella and Porous Tibia Baseplate
- K211332 — D Camera Controller
Data sourced from openFDA. This site is unofficial and independent of the FDA.