FDA 510(k) clearances — page 297
clearances on record, most recent first.
Clearances — page 297
29,601–29,700 of 175,699- K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
- K163285 — syngo Application Software
- K163460 — Reveal LINQ Insertable Cardiac Monitor
- K163548 — ENSEAL X1 Large Jaw Tissue Sealer
- K163619 — SIGNA PET/MR
- K170163 — Erisma® LP Spinal Fixation System
- K160610 — Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
- K160918 — JUVORA Dental Disc, Ceramill PEEK by JUVORA
- K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
- K162456 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K162508 — KerraCel Ag Gelling Fiber Silver Dressing
- K162860 — MCS Bone Graft
- K163146 — POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
- K163380 — Serranator Alto PTA Serration Balloon Catheter
- K163487 — Ultima HA Coated Half Pins and Wire
- K170193 — Advance 14LP Low Profile PTA Balloon Dilatation Catheter
- K161213 — XSmart iQ
- K161226 — Revision Femoral Stem
- K161415 — SteriTite Containers System & MediTray Products
- K161606 — Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
- K161629 — CRYLREX
- K162089 — Blood Pressure Monitor
- K162321 — EasyClip Xpress
- K162697 — Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
- K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
- K163217 — GORE BIO-A Tissue Reinforcement
- K163395 — Astroglide Diamond Silicone Gel Personal Lubricant
- K163596 — LOGIQ P9 and LOGIQ P7
- K161334 — RASL Repair Kit
- K161413 — Low Profile Balloon Feeding Device
- K161491 — Scopis Hybrid Navigation System EM
- K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- K161861 — APTUS® Coronoid 2.0
- K162158 — Porcine Anorganic Bone Mineral in Delivery Applicator
- K162331 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K162611 — PeriFLEX
- K162710 — Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
- K162918 — Atlas Spine Expandable Interbody System
- K163046 — DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
- K163184 — cobas® CT/NG v2.0 Test
- K163289 — syngo. CT Single Source Dual Energy (twin beam)
- K163341 — syngo.CT Extended Functionality
- K163478 — AcuNav Volume ICE Catheter
- K163508 — PIVO
- K163566 — Hubble I System
- K170086 — Pinnacle Radiation Therapy Planning System
- K170091 — UA-Cellular Complete
- K170113 — pixium 4343RCE
- K160444 — FB-U Hemodialyzer
- K161432 — MyNeWT Negative Pressure Wound Therapy System
- K161468 — Transformair Indoor Air Purifier
- K161577 — Arm-Type Fully Automatic Digital Blood Pressure Monitor
- K162039 — OptosAdvance 4.0 Software
- K162479 — Smart Pain Reliever, Model LT5019
- K162491 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
- K162852 — Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
- K162915 — Fully Automatic Electronic Blood Pressure Monitor
- K163173 — Handheld Diode Laser for Hair Removal
- K163703 — VIVIX-S 1417N
- K153262 — PUREtrace
- K161715 — EndyGel
- K161980 — Fuselier Intraoral Nighttime Device (FIND)
- K162639 — Proficient Posterior Cervical Spine System
- K163169 — Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
- K163214 — Unicare System, Unicare Manipulator
- K170072 — Fitmore® Hip Stem
- DEN160016 — Variola virus Real-Time PCR Assay
- K160934 — UC-CARE NaviGo Workstation
- K162014 — Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
- K162283 — DCM Kyphoplasty System
- K162923 — NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE
- K162973 — EndoWrist Suction Irrigator
- K163061 — Altus Spine Cervical Plate System
- K163294 — syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
- K170330 — 3M Protemp Cement Temporary Dental Cement
- DEN150035 — SEEKER System
- K152432 — ActiPatch(R)
- K161025 — priti multidisc ZrO2 High Translucent
- K161056 — Telemetry Transmitter
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
- K161901 — TrapLiner catheter
- K162106 — Micro-current Wrinkle Reduction Facial service, model EP-400
- K162388 — CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
- K162439 — AxSOS 3 Ti; Stryker Plating System
- K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
- K162683 — RehaStim 2
- K163155 — MTM Clear Aligner
- K163452 — PICC Maximal Barrier Nursing Kit
- K163551 — LenSx Laser System
- K160835 — Titan 3W
- K161103 — US SA Implant System
- K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
- K163123 — Q-Switched Nd:YAG Laser Therapy Systems
- K163268 — FlexCath Select Steerable Shealth and Dilator
- K163428 — HA Minuteman G3-R MIS Fusion Plate
- K163511 — NovaGuard SA Pro Safety System
- K170019 — Aquilion Lightning, TSX-036A/1, V8.4
- K170061 — ProMIS Fixation System
- K161279 — Life Spine Metatarsal Hemi Implant
Data sourced from openFDA. This site is unofficial and independent of the FDA.