FDA 510(k) clearances — page 343
clearances on record, most recent first.
Clearances — page 343
34,201–34,300 of 176,542- K151212 — Ziostation2
- K151383 — NeuViz 128 Multi-slice CT Scanner System
- K152236 — KATOR Suture Anchor
- K151019 — SternaLock® 360 Sternal Closure System
- K152295 — Talon DistalFix Antegrade/Retrograde Femoral Nail
- K152580 — rescuenet
- DEN150008 — INVOcell
- K142941 — Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
- K143584 — PGA RESORBA, PGA RESOQUICK, GLYCOLON
- K150713 — syngo.CT Myocardial Perfusion
- K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
- K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency +3 more
- K151872 — Avance Y-Connector S
- K151992 — FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
- K152183 — EXELINT SecureTouch Safety Hypodermic Needle
- K152570 — Bovie J-Plasma Precise 360 Handpiece
- K152592 — PROBEAT-V
- K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
- K152962 — HS70A Diagnostic Ultrasound System
- K142410 — Elliquence Electrodes
- K143420 — SYMBIS Surgical System
- K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
- K150462 — Vera
- K150595 — SCENARIA Phase 3 Whole-body X-ray CT System
- K151109 — Lumenis Smart532 Laser System
- K151283 — Lung Analysis Software
- K151366 — Philips CS770 IntelliSpace Critical Care and Anesthesia
- K151531 — MasterLoc Stem
- K151619 — Prime&Bond Elect Universal Dental Adhesive
- K151788 — Cardinal Health Sterilization Wrap
- K151886 — Acumed Ankle and Small Fragment Base Set Update
- K151888 — Frontier Medical Devices In-line Orthopedic Cable Cerclage System
- K152040 — X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
- K152273 — Cosmedico Ultraviolet Lamps of Various Models
- K152312 — RECON system-V-TEK-IVP Plates and Screws
- K152357 — MicroSTAAR Injector System Cartridges
- K152381 — Prelude SNAP Splittable Hydrophilic Sheath Introducer
- K152481 — DURAFORM Dural Graft Implant
- K152899 — Philips Lumify Diagnostic Ultrasound System
- K141854 — INSTRUMENT CASSETTE (EFCCL1-F)
- K143117 — Wire Sterilization Package with Indicators
- K143582 — MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
- K143716 — DSM Biomedical DPR Cable
- K143727 — PENTAX Medical EKP-i5010 Video Processor with EB Family
- K150523 — AVAmax Vertebral Balloon
- K150568 — ARROW Humeral stems size 6 and 16
- K151159 — Leksell Gamma Knife Perfexion
- K151456 — Small Bone Nail Implant
- K151715 — T3 Software
- K151718 — iFuse Implant System
- K151758 — ALAR Nasal Valve Stent
- K151875 — Pavati Zirconia
- K151894 — IPS Ivocolor
- K151971 — STERRAD CYCLESURE 24 Biological Indicator
- K152008 — Physica PS Knee System
- K152120 — OPTIS Mobile System
- K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
- K152159 — Oravan Herbst
- K152367 — Optiflux dialyzer
- K152465 — Disposable Blood Pressure Cuff
- K152468 — Reusable Blood Pressure Cuff
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
- K152543 — M9/M9CV/M9T Diagnostic Ultrasound System
- K152605 — Impulse Angiographic Catheter, Expo Angiographic Catheter
- K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
- K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
- K151535 — Cavex Cream Alginate
- K151723 — Rainbow Trans
- K152039 — Genesys Spine TiLock2 Spinal System
- K152095 — Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
- K152124 — Tempus IC2
- K152204 — VS3-IR system
- K152315 — JOURNEY II Uni Tibial Base and Insert
- K152338 — VERTEX(r) Reconstruction System
- K152795 — RiverLon (Nylon) Suture
- K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
- K150241 — Genesis II XLPE Resurfacing Patellar Components
- K150780 — Acetabular Cup Orientation System
- K151629 — Guardian 1000
- K151769 — Anchorage 2 CP System
- K151865 — PremiPatch PTFE Pledget
- K151954 — A7 Anesthesia System
- K152152 — Codman Certas Plus Programmable Valve
- K152169 — Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
- K152363 — Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
- K152457 — CD HORIZON Spinal System
- K152607 — Express SD Biliary Monorail Premounted Stent System
- K152801 — ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
- K152870 — BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
- K152874 — BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
- K153003 — SIGNA Pioneer
- K150270 — ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
- K151182 — LiquiBand Exceed
- K151489 — Retrieval bag system
- K151882 — Varian Treatment (VTx)
- K152028 — Volpara Imaging Software
- K152092 — Resection Electrodes
- K152665 — PolarCath Peripheral Dilatation System
- K143235 — RF20000a Controller, FLOW 50 Wand
- K143670 — ICS CHARTR EP 200 WITH VEMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.