FDA 510(k) clearances — page 331
clearances on record, most recent first.
Clearances — page 331
33,001–33,100 of 176,542- 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)
- K151943 — Vas-Q-Clip
- K152200 — SurgTech Interbody System
- K152274 — MSCB-001
- K152470 — Great Basin Staph ID/R Blood Culture Panel
- K152808 — U&U Insulin Syringe with/without Safety Retractable Device
- K152978 — DeRoyal Angiography Kits
- K153337 — Corvocet Biopsy System
- K153441 — VibraPEP
- K153595 — Optetrak Logic Metaphyseal Cones
- K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System
- K153725 — Corin TaperFit Hip Stem
- K160191 — Align Anterior Ankle Fusion Plate
- K160273 — truFreeze System
- K160277 — LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
- K150702 — Exceed Tx
- K151342 — Arthrex SwiveLock Anchors
- K151461 — Hybernite RT
- K151778 — Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
- K151881 — X-Fix Line Additions
- K152253 — Biomet Microfixation RibFix Blu Thoracic Fixation System
- K152716 — EV Insite System
- K153202 — iMESH Tacker
- K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
- K153392 — STERIZONE VP4 Sterilizer
- K153667 — TRUESPAN Meniscal Repair System
- K153782 — NuVasive® Lumbar Interbody Implants
- K160547 — Cascadia Interbody System
- K152090 — Reprocessed Steerable Introducer
- K152199 — RejuvatoneMD
- K152631 — MPO Total Knee Systems MR Labeling
- K152933 — Vesalius
- K152975 — VDT985US Vicks SmartTemp Thermometer
- K153758 — Straumann Bone Level Tapered Implants
- K160259 — ZELTIQ CoolSculpting System
- K160466 — Response 5.5 Spine System
- K160479 — PointerShell Universal, PointerShell LS
- K143468 — QbCheck
- K151754 — Glide-On Vinyl Examination Gloves
- K152051 — ClearMet
- K152337 — cryoFORM cryoICE cryoablation probe
- K152955 — Great Basin Shiga Toxin Direct Test
- K153324 — Ingenia 1.5T and Ingenia 1.5T S R5.2
- K160098 — Single Use Aspiration Needle NA-U401SX
- K160362 — Z-Span Plate System
- K160521 — ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
- K150566 — Oniris
- K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
- K153510 — Powder Free Polychloroprene Examination Glove Green
- K153554 — Genesis Low Temperature Reusable Rigid Container System
- K153717 — Venus Versa System
- K153770 — OS2(R)-VP Varisation Staple
- K160120 — D-SPECT Processing and Reviewing Workstation
- K160229 — Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
- K160420 — SpeqT
- K150588 — OVA1 Next Generation
- K150915 — SPINAUT-P
- K151433 — AUDICOR CA300/CC100 Analyzer with SDB
Data sourced from openFDA. This site is unofficial and independent of the FDA.