FDA 510(k) clearances — page 268
clearances on record, most recent first.
Clearances — page 268
26,701–26,800 of 175,699- 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
- K173073 — AltiVate Anatomic to Reverse Conversion Module
- K170960 — CoaguChek Vantus System
- DEN160014 — remOVE System
- K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
- K171581 — Neuro Omega System
- K171584 — B. Braun Tear-Away Introducer Needle
- K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
- K172383 — Arthrosurface Bone Screws
- K172388 — VPOD ITPR
- K172507 — SOZO
- K172688 — Align Radial Head System
- K172706 — GammaPod - Model A
- K172785 — CONQUEST FN
- K172978 — SurgeoBite
- K173492 — MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
- DEN170024 — AQUABEAM System
- K170005 — FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
- K170028 — FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
- K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
- K171102 — Ives MR Conditional Cup Electrode
- K171109 — Praxiject 0.9% NaCl
- K171434 — ROCCIA® MultiLIF
- K171530 — Deltaven XiV Max, Deltaven XiV Max FF
- K171848 — FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
- K171877 — SLM-1ER, SLM-2ER, SLM-3ER
- K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer
- K172185 — Tyber Medical PT Interbody Spacer System
- K172321 — Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
- K172330 — Blustone Synergy Silica System
- K172448 — Riptide Aspiration System
- K172467 — OMNI ARC Anteverted Neck Hip Stem
- K172560 — PREMIUM ONE Implant Systems
- K172623 — NuVasive Navigation Instruments
- K172893 — SafeSept Needle Free Transseptal Guidewire
- K172922 — MMPC-4127F1
- K172926 — SeaSpine Vu cPOD, Zuma-C, Complete Cervical
- K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
- K172973 — Life Spine Foot and Ankle Plating System
- K173250 — Solana GBS Assay
- K173287 — Elite HV Radial
- K173332 — OMNI Surgical System
- K173375 — Anterior Cervical Plate System
- K163550 — Pobling MIITY 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.