FDA 510(k) clearances — page 296
clearances on record, most recent first.
Clearances — page 296
29,501–29,600 of 175,699- K163056 — Revolution Spinal Fixation System
- K163480 — Renamel NANO +plus
- K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K170218 — Vesco Medical NRFit Tip Syringes
- K170257 — Sydney IVF Culture Oil
- DEN160032 — Accelerate Pheno system, Accelerate Phenotest BC Kit
- K160837 — MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
- K161099 — Powder Free Nitrile Examination Gloves, Black
- K161316 — George King Coumadin Plasma
- K161335 — Dual Top Screw System
- K161607 — VISULUX
- K161693 — Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
- K161848 — Family of Steam sterilizers B17 B22 Series
- K161907 — Pressure Therapy System
- K162484 — Lung Nodule Assessment and Comparison Option (LNA)
- K162670 — RSM 1824C with RConsole1
- K162827 — VIDAS B.R.A.H.M.S. PCT (PCT)
- K162855 — Reveal LINQ
- K162922 — GalaFORM 3D
- K162926 — Air-Powered Handpieces and Handpiece Attachments
- K162937 — Stryker OrthoMap Versatile Hip System
- K163168 — Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
- K163279 — Medtronic Transportation/Sterilization Cassettes
- K163322 — TZ SKULL PIN Adult
- K163688 — Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
- K170209 — ImPACT
- K170240 — Truliant Femoral Components
- K170265 — GRAVITYTM PEEK-OPTIMA Suture Anchor
- K151834 — BEMER Classic Set, BEMER Pro-Set
- K152022 — SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer
- K161500 — MEG-TORQ
- K161534 — EasyOne Pro Respiratory Analysis System
- K161926 — ND YAG Q-switch Laser Therapy Machine
- K162795 — PROPHECY INVISION Preoperative Navigation Alignment System
- K162800 — BLUEPRINT Patient Specific Instrumentation
- K162911 — Sofia RSV FIA on Sofia 2 analyzer
- K162929 — Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
- K163041 — Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
- K163126 — Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
- K163298 — Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
- K163535 — my Patch sl
- K163691 — HS70A Diagnostic Ultrasound System
- K170202 — Aquarius 8600
- K161120 — SMR TT Metal Back Glenoid, Bone Graft instruments
- K161894 — SurgTech Trauma System
- K161987 — UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
- K162032 — Arrowhead Mini-Rail Fixator
- K162391 — AlignMATE Lapidus Arthrodesis System
- K162841 — VariAx Distal Radius Plating System, VariAx 2 System
- K163045 — Omron HEM-6400T-Z Wrist Blood Pressure Monitor
- K163051 — ClearLumen II Peripheral Thrombectomy System
- K163091 — VibraPEP
- K163273 — TRU Legionella
- K163317 — ELECTROmatic
- K170258 — SpeedLyser Infusion Catheter Kit
- K162565 — VIA 17 Microcatheter
- K163272 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- K160799 — GenNarino
- K161411 — Care Cycle Connect Application
- K161953 — ReDe Mask
- K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
- K162824 — Z-Span Plate System
- K162875 — Sentry IVC filter
- K163037 — Intra medullary endo-transilluminating device (iMET device)
- K163260 — SeptiCyte LAB
- K163651 — ExpressBraid Graft Manipulation
- DEN140033 — Companion
- K153561 — AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
- K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
- K161521 — TAP Blood Collection Device
- K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
- K161764 — SLIT LAMP, Model: YF-100
- K161996 — 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
- K162007 — STERRAD NX Sterilizer
- K162365 — T-Cuff
- K162402 — 4CIS® Marlin ACIF Cage System
- K162481 — RF1400 Active Compression Wrap
- K162570 — Miromatrix Biological Mesh TW
- K162760 — Spine Wave Anterior Cervical Spine System
- K162833 — VitriGuard
- K162849 — Huvex Interspinous Fixation System
- K162965 — SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
- K163165 — AM-100
- K163374 — ALLY Facet Screws
- K163416 — Fiagon Navigation PointerTube Straight and PointerTube Keat
- K163549 — ClotTriever Thrombectomy System
- K163602 — Kepler I Cervical Plate System
- K170103 — Laparoscope Lens Shield Device (LENS)
- K170170 — Valleylab FT10 Electrosurgical Platform
- K160876 — PC ECG
- K161811 — Medela Low Dose Enteral Syringe
- K162099 — IBS Implant System II
- K170160 — Abbott ARCHITECT Free T3
- DEN160048 — FilmArray NGDS Warrior Panel
- K162590 — Bashan TDP Heat Lamp
- K162608 — ClariFix Device
- K162668 — Fully Automatic Electronic Blood Pressure Monitor
- K162830 — SIS Software
- K162987 — FA100 SCCD (Sequential Continuous Contraction Device)
Data sourced from openFDA. This site is unofficial and independent of the FDA.