FDA 510(k) clearances — page 265
clearances on record, most recent first.
Clearances — page 265
26,401–26,500 of 175,699- K173561 — Vinyl Patient Examination Glove (Yellow)
- K173579 — Thorecon Fixation System
- K173634 — CELERITY 20 Steam Biological Indicator
- K173670 — CELERITY 20 Steam Incubator
- K173710 — MotoBAND CP Implant System
- K180118 — Arthrex NanoSuture Anchor
- K180082 — geko T-2 and geko Plus R-2
- K170131 — TAV Medical Dental Implants System
- K171179 — BR Type Implant System
- K171455 — AT-6XX Series Infrared Thermometer
- K171631 — Standard Catheter Set
- K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
- K172160 — Southern Implants PEEK Abutments
- K172180 — OSCAR 15
- K172284 — NAPA LP-15 Airway Pressure Monitor
- K172422 — Kohli Urinary Drainage Catheter
- K172504 — Tosama Biobased Applicator Tube Menstrual Tampon
- K172746 — VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
- K172748 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
- K172749 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K172751 — iVitri Straw
- K172752 — CELERITY 20 HP Biological Indicator
- K172753 — VERIFY VH2O2 Indicator Tape
- K172754 — V-PRO maX 2 Low Temperature Sterilization System
- K172755 — PRO-LITE Sterilization Trays
- K173163 — ChlorCid, ChlorCid V, ChlorCid Surf
- K173272 — Ergonomic Handle
- K173400 — ORISE Tissue Retractor System
- K173435 — 3M Attest Rapid Readout Biological Indicator
- K173501 — Meridian Vaginal Positioning System (VPS)
- K173523 — BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
- K173791 — Leksell GammaPlan
- K173823 — Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System
- K173894 — Jade PTA Balloon Dilatation Catheter
- K180107 — Blue Sky Bio Aligner
- K162727 — SENYINT Remote Consultation System
- K173025 — NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System
- K173244 — superDimension Navigation System V7.2
- K173335 — Gazelle PTFE and Suture Delivery Device
- K173411 — Comprehensive Segmental Revision System (SRS)
- K173537 — CONCORDE LIFT
- K173553 — LUCAS 3 Chest Compression System
- K173805 — NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
- K180084 — Ultrasound System SONIMAGE MX1
- K180091 — UNiD Spine Analyzer
- K161222 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope
- K171520 — SteriZign Signatur Device Protection System
- K171861 — CAPILLARYS Hb A1c
- K172698 — G-Beam Fusion Beaming System
- K173199 — PicoSure Workstation
- K173450 — PRESS DUO elite, PRESS DUO elite AG
- K173826 — THP Hip Fracture Plating System
- K180067 — ACUSON X800 Diagnostic Ultrasound System
- K171375 — Gammex PI Breach Detect Powder Free Surgical Glove
- K171557 — AcQRef Introducer Sheath
- K171641 — Accula Flu A/Flu B Test
- K172490 — eUnity
- K172832 — Insight BD
- K172953 — Acid Etchant
- K173528 — Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
- K173882 — SeaSpine Mariner Pedicle Screw System
- K171208 — Trans-anal Introducer
- K171361 — BETTERCARE PLATFORM - ADVANCED WEB CLIENT
- K171516 — Flip Lube
- K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
- K172040 — Aquilex Fluid Control System AQL-100S
- K173204 — RS85 Diagnostic Ultrasound System
- K173433 — ProxiDiagnost N90
- K173512 — MFI-Cardiac
- K173672 — FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
- K173924 — DRX-Revolution Nano Mobile X-ray System
- K170112 — IMD's Lumbar Puncture Needle
- K171402 — KARL STORZ Slim Nasopharyngolaryngoscope
- K171403 — OralTox Oral Fluid Drug Test
- K171450 — Glooko Mobile Insulin Dosing System
- K172005 — PICO 7 Single Use Negative Pressure Wound Therapy System
- K172105 — The Plateau-LO Spacer System
- K172237 — Bicera Resorbable Bone Substitute
- K172512 — ACRO HCG Pregnancy Rapid Test
- K173445 — Materialise TKA Guide System
- K173800 — Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage
- K173849 — Triathlon Total Knee System
- K173981 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
- K180036 — SMAXEL CO2 Surgical Laser System
- K180070 — SpeediCath Flex Coude Pro
- K161989 — PREMIUM Implant Systems SHELTA Implant Systems
- K171287 — Sporview VH202 BI
- K171384 — Micromed BRAIN QUICK system
- K171629 — ABCcolla Bone Graft
- K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
- K172146 — MERISTEEL
- K172395 — Duatene bilayer mesh
- K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test
- K172789 — Specimen Retrieval Bag
- K172828 — Double Medical Cage System
- K173047 — The Solstice OCT System
- K173443 — AEON Endoscopic Stapler
- K173957 — ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
- K180039 — ACUSON P600 Diagnostic Ultrasound System
- K171297 — AR_N Type Implant System
Data sourced from openFDA. This site is unofficial and independent of the FDA.