FDA 510(k) clearances — page 272
clearances on record, most recent first.
Clearances — page 272
27,101–27,200 of 176,542- K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- K173145 — CereMetrix Silver
- K173186 — S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
- K173367 — MC 300* Nebulizer
- K173633 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
- K173678 — Diode Laser Cap
- K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- K173707 — P200TE
- K173729 — REVIAN RED
- K173736 — TrackX
- K173739 — ALOKA ARIETTA 850
- K173763 — iovera system
- K173817 — Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
- K180242 — HeRO Symphony, HeRO ES, HeRO solo/duet
- K180244 — EnsoETM
- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K170623 — ACE Hemoglobin A1c (HbA1c) Reagent
- K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
- K172042 — NeuroNav System, NeuroSmart System
- K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
- K173275 — OMNICHROMA
- K173324 — ALTA Anterior Cervical Interbody Spacer
- K173343 — Zygomatic Implant System
- K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
- K173746 — Activmotion Range
- K180237 — Rezum System
- K170175 — ENDOSEAL MTA
- K171637 — OpClear System
- K171668 — Bluetooth blood pressure monitor
- K171797 — TRYPTIK2 C-Plate Anterior Cervical Plate System
- K172320 — Neurostructures Cavetto® Cervical Cage System
- K172899 — Vygon PICCs
- K180327 — Stryker iVAS 13g Bone Biopsy Kit
- K173643 — Trilor Disks, Blocks and Arches
- K170540 — DM-Density
- K171601 — Ultraxx Nephrostomy Balloon Catheter
- K171671 — Prismaflex System 8.10
- K171869 — Sutter CURIS RF Generator
- K172324 — Axiostat Chitosan Hemostatic Dressing
- K173077 — Cavetto-SA Cervical Cage System
- K173224 — SPIN-SWI
- K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
- K173320 — KLS Martin L1 MMF System
- K173468 — Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
- K173491 — RTS Lesser MTP Implant System
- K173493 — Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
- K173569 — Ultrasound System 1300
- K173677 — InMode VLaze
- K173689 — Ophthalmic Software Platform RX
- K173693 — Orbitum Bone Staple Implant, X and VI
- K173863 — Ez3D-i /E3
- K180130 — ELEOS Bipolar Acetabular System
- K171171 — KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
- K171568 — SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
- K171576 — The Panthera Anti-Snoring X3 Device
- K171649 — Straumann CARES M-Series CAD/CAM System
- K171823 — U&U Indicator tape and strip
- K171994 — Silicone Peripherally Inserted Central Venous Catheter Set/Tray
- K172294 — Osteotomy Truss System (OTS)
- K172541 — Medline Catheter Specimen Collector
- K173067 — LightForce LTS Model 1000, 1500, 2500, and 4000
- K173236 — Sentry IVC Filter
- K173255 — Talon DistalFix Humeral Nail
- K173334 — SeaSpine Spinous Process System
- K173381 — Nexxis OR
- K173402 — Neocis Guidance System (NGS) with Chairside Splint
- K173485 — Amsco Evolution Medium Steam Sterilizer
- K173490 — Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
- K173967 — Remedy Acetabular Cup
- K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
- K180181 — Natus Quantum
- K163377 — Captura Disposable Bronchoscope Biopsy Forceps
- K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
- K171620 — PiCCO Catheter
- K172338 — Catasyn Advanced Technology Wound Hydrogel
- K172647 — Reprocessed ArthroCare ENT Coblator
- K172950 — TSN Transseptal Needle
- K173626 — Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- K173629 — CELERITY 20 Steam Process Challenge Device for Gravity Cycles
- K173963 — DRI Benzodiazepine Assay
- K180193 — DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
- K170683 — Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
- K171605 — Elecsys CA 15-3 II
- K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- K172885 — HydroPICC
- K173228 — U-MED Powder Free Polyethylene Examination Gloves,Blue Color
- K173270 — Tri-Staple 2.0 Reinforced Reload
- K173513 — WS80A Diagnostic Ultrasound System
- K180176 — SeaSpine NewPort Spinal System
- K172390 — Optima Coil System
- K171521 — DUS R-50S (Urine Chemistry system)
- K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter
- K171646 — ACISTCVi® Contrast Delivery System
- K172208 — NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
- K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
- K172361 — EEA Circular Stapler with Tri-Staple Technology
- K172934 — Needle Free Transseptal Cannula
- K173409 — Wireless Audio System
- K173460 — NeuroEEG
- K173587 — Magseed Magnetic Marker Systtem
Data sourced from openFDA. This site is unofficial and independent of the FDA.