FDA 510(k) clearances — page 276
clearances on record, most recent first.
Clearances — page 276
27,501–27,600 of 176,542- K172110 — ECHELON OVAL V6.0A MRI System
- K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control
- K172205 — ExoToe Staple
- K172224 — DTX Studio diagnose
- K172452 — Bruxor
- K172655 — Automated ankle brachial pressure index measuring device
- K172804 — Besmed Peak Flow Meter
- K172992 — Diazyme EZ Vitamin D Assay
- K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
- K171421 — VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
- K171445 — Amplatz Support Wire Guide with Apex Curve
- K171722 — Electrodes with snap / Electrodes with pigtail
- K171833 — Digital Blood Pressure Monitor-Wrist Style
- K172051 — Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
- K172336 — Smith & Nephew Patient Matched Cutting Blocks
- K172358 — Instalief
- K172929 — Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
- K173170 — Epicardia Anywhere
- K173234 — Swiss LithoClast Trilogy
- K173563 — ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
- K173768 — Tempus Pro Patient Monitor
- K163026 — Ultra/Phonic Scanning Gel
- K163027 — Ultra/Phonic Free Conductivity Gel
- K171295 — ULab Systems Treatment Planning Software
- K171775 — Theradome LH80 PRO
- K172183 — Guided Growth Plate System Plus
- K172193 — Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
- K172212 — MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK
- K172662 — reVive Perioral
- K173021 — Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
- K173263 — Xpert Carba-R
- K173469 — 16ch T/R Hand Wrist Coil
- K173508 — Everest Spinal System
- K163023 — Other-Sonic Transmission Gel
- K163024 — Ultra/Phonic Conductivity Gel
- K171328 — cNeuro cMRI
- K172858 — PreOp
- K172942 — Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
- K173085 — invendoscopy E210 System
- K173159 — Cervical Spinal Truss System (CSTS) Interbody Fusion Device
- K173293 — EVOS Small Fragment Upper Extremity Plates
- K173471 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
- K173759 — Thermage CPT System and Accessories
- K171099 — EON Portable Reverse Osmosis Water Purification System
- K171436 — STRONG Dental Handpieces
- K171518 — Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
- K171721 — Electrodes with silver conductive
- K171860 — Sureclear aligners
- K171948 — Roadrunner Extra Support Wire Guide
- K172029 — EnsoETM
- K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP
- K172518 — Spineology Navigation Instruments
- K172968 — Hair Up
- K173252 — BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
- K173278 — ToggleLoc System
- K173456 — ViewPoint 6
- K173650 — AquaShield System CO2- Fujifilm
- K171056 — WAVE Clinical Platform
- K171113 — LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
- K171235 — OmniCap
- K171372 — Alians Elbow Locking Plating System
- K171410 — ePatch
- K171819 — Attain Assist CS Access Catheter
- K171836 — EarlySense Bed Sensing Unit
- K172456 — Bone Screws 6.5mm
- K172701 — BIO-C SEALER
- K172702 — Tec 820, Tec 850
- K170924 — AirFit F20
- K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
- K172798 — Straumann CARES Abutments CoCr
- K173198 — Facet Screw Fixation System
- K173702 — Juliet Ti LL
- K163712 — Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
- K171529 — Snorer's Friend
- K172860 — Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
- K170165 — Osteo-P Bone Graft Substitute
- K171108 — AUTOBAHN Nailing System
- K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
- K172357 — Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
- K172474 — Celerity 20 HP Biological Indicator
- K173102 — Reliance Cervical IBF System
- K173403 — GEM Premier 5000
- K173664 — Medtronic O-arm O2 Imaging System
- DEN160037 — dermaPACE System
- K163328 — Planmed Clarity
- K171061 — MRSASelect II
- K171269 — X-PSI Knee System
- K172505 — MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
- K173087 — UroLift System (UL400 and UL500)
- K173652 — Piccolo Composite Nailing System
- K170104 — COMPACT S, COMPACT S (LED)
- K171037 — PoreStar Patient Specific Implant
- K172848 — MEVION S250i Proton Beam Radiation Therapy Device
- K173420 — Radiomics App v1.0
- K170138 — NEURONAUTE
- K171049 — Real Time Image Gating System for Proton Beam Therapy Systems
- K172645 — iLux Instrument, iLux Disposable
- K172904 — IntelliVue Capnography Extension, IntelliVue Microstream Extension
- K173008 — SCS 17-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.