FDA 510(k) clearances — page 277
clearances on record, most recent first.
Clearances — page 277
27,601–27,700 of 176,542- 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
- K170950 — Well-Root ST
- K170972 — Apex Tibial Nailing System
- K171275 — Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
- K171866 — Sentrant Introducer Sheath with Hydrophilic Coating
- K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
- K172886 — Breakaway Screw System
- K172989 — Electric Breast Pump
- K173115 — COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
- K173125 — T2 STRATOSPHERE Expandable Corpectomy System
- K173182 — ProLift® Expandable System
- K173349 — Operio
- K173555 — LOGIQ E10
- K173578 — Biograph mCT Family of PET/CT Systems
- K173662 — speX Support Catheter
- K173685 — Peel-Away Introducer Set
- DEN160062 — IlluminOss Bone Stabilization System
- DEN170075 — ContainOR
- K170862 — Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
- K171012 — Veraview X800
- K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K171834 — G Surgical OCT Spinal System
- K171889 — Reusable Blood Pressure Cuff
- K172677 — Advantage Plus Pass-Thru
- K172743 — Natus VikingQuest
- K172861 — Digital thermometer(with disposable thermometer cover)
- K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL
- K172982 — SuperGrow 272, Ultimate 272
- K172986 — Zmachine Synergy
- K173130 — Reform® Midline Cortical Screw System
- K173251 — LumiCoil Platinum Fiducial Marker
- K173307 — Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
- K173600 — MAGNETOM Amira
- K173618 — ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
- K173646 — FS Ergo
- K173696 — TBL-ABI System
- K171174 — PERIO-FLOW nozzle
- K171193 — Certa Catheter
- K171858 — Sidus Stem-Free Shoulder
- K172286 — Automated Blood Coagulation Analyzer CS-2500
- K172918 — DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
- K173124 — PEEK Biosolution
- K171909 — HAL for Medical Use (Lower Limb Type)
- K163607 — ECG Acquisition Systems
- K170029 — FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
- K170497 — V10
- K170913 — Composite Removable Sinus Stent System
- K171271 — Polyform Synthetic Mesh
- K171483 — ArchFlo CT Midline
- K171611 — Double Lumen Ovum Aspiration Needles
- K172228 — pioli IOL Delivery System
- K172311 — BioFlux Device
- K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
- K172350 — AxSOS 3 Ti
- K172465 — Idys TLIF 3DTi Cages
- K172473 — LifeStyles® SKYN® Intimate Moments Personal Lubricant
- K172482 — The Nellcor pulse oximetry monitor interface cable
- K172494 — PROTEUS PTA Balloon Catheter with Embolic Capture Feature
Data sourced from openFDA. This site is unofficial and independent of the FDA.