FDA 510(k) clearances — page 322
clearances on record, most recent first.
Clearances — page 322
32,101–32,200 of 175,699- K142754 — Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
- K152194 — transGlide Expandable Introducer
- K152439 — U2 Bipolar Implant and 22mm Femoral Head
- K152700 — StrataMR Valves and Shunts
- K152864 — Merge Hemo
- K153093 — FIRMap Catheter
- K153163 — ReGrasp
- K153555 — EM ENT Navigated Suctions
- K160343 — SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
- K160351 — CX50N, CX50YQS
- K160355 — CX20N(CX20PUX)
- K160651 — BD FlowSmart Set, MiniMed Pro-Set
- K160659 — ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
- K151983 — KLS Martin LSS Plating System
- K153293 — Extension Set
- K153482 — KLS Martin Thoracic Plating System
- K153566 — Magma System
- K153634 — Wireless Earlens Light Driven Hearing Aid
- K153722 — SMR 3-Pegs Glenoids
- K160807 — EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K151503 — NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
- K151683 — SleepWeaver Advance Pediatric Nasal CPAP Mask
- K152652 — PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
- K152947 — Disposable Temporary Pacing Cable
- K153009 — ULTRA Telescopes
- K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
- K160160 — Non-Telescopic PenEvac
- K160360 — Barrx FLEX RFA Energy Generator
- K160368 — EVO platform
- K160734 — SonoSite SII Ultrasound System
- K151650 — SMARTez elastomeric infusion pump
- K151967 — Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
- K152228 — Hydroven 12, Hydroven 12 Garments
- K152479 — HG Pro Nitrile Powder Free Examination Gloves
- K153481 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
- K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
- K160283 — S45 Digital Color Doppler Ultrasound System
- K160325 — PRECICE Intramedullary Limb Lengthening System
- K160464 — Opticage(R) Expandable Interbody Fusion Device
- K160790 — Acclarix LX8 Diagnostic Ultrasound System
- K143548 — TRUE METRIX GO Self Monitoring Blood Glucose System
- K143690 — Ekso (version 1.1) and Ekso GT (version 1.2)
- K151156 — Fiagon Navigation System
- K152881 — SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
- K153249 — Pulpdent Solo Flowable Composite with MCP
- K153263 — Aquilion Lightning, TSX-035A/4 and /5, V7.0
- K153486 — Affirm Prone Biopsy System
- K153562 — Powder Free Blue Nitrile Examination Glove
- K153583 — BioVision Plus
- K160258 — X5 Digital Color Doppler Ultrasound System
- K160318 — PlasmaFlow
- K160320 — Premier
- K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- K151612 — NewTom VGi evo
- K151832 — NOVATECH TALCAIR
- K151932 — Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
- K151997 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
- K152021 — Pure Tilt
- K152258 — T3 Software
- K152428 — SensiCare PI Surgical Gloves
- K152480 — Revitive Medic; Revitive MV; Revitive LV
- K152969 — ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
- K153146 — Infrared Ear Thermometer
- K153291 — SICAT OPTISLEEP
- K153348 — JAZZ LOCK
- K153447 — MAGNETOM Spectra
- K153465 — AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
- K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
- K153547 — ECHELON Oval V 5.1 MRI System
- K153687 — Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
- K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove
- K153772 — Corin TriFit TS Hip
- K153779 — Abutment for Bridges
- K160267 — PRECICE Trauma Nail System
- K160861 — Proxis Ureteral Access Sheath
- K143035 — Flight 60 Ventilator
- K152578 — da Vinci Surgical System, Model IS4000
- K153160 — AVIVO Mobile Patient Management (MPM) System
- K153281 — BrightMatter Guide with Surface Trace Registration
- K153389 — Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
- K160620 — Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
- K160637 — Rotatable Snares
- K151252 — Puritan Bennett 840 Series Ventilator System
- K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
- K153284 — Synaptive ImageDrive Pro
- K153564 — PURE CRYOGEN
- K153767 — X-cera Zirconia Blanks
- K160336 — Full Automatic (NIBP) Blood Pressure Monitor
- K160621 — SIGNAPioneer
- DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
- K152640 — Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
- K153042 — TRYPTIK2C-plate Anterior Cervical Plate System
- K153371 — Sonicision Cordless Ultrasonic Dissection Device
- K160212 — ACUVUE (senofilcon C) Soft Contact Lens
- K160528 — ANATOMIC PEEK PTC Cervical Fusion System
- K160603 — SMV Scientific Schanz Screws
- K160129 — MRII Cranial Drill and Accessories
- K151765 — SOMATOM Perspective
- K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
- K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.