FDA 510(k) clearances — page 349
clearances on record, most recent first.
Clearances — page 349
34,801–34,900 of 176,542- K151333 — LightStim for Pain LED Belt
- K151422 — Reform Pedicle Screw System
- K151516 — Capillus82
- K151756 — STERISPINE LC CAGE
- K152045 — SALVATION® External Fixation System
- K141017 — PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
- K143325 — OC-Light S FIT
- K143354 — Natrelle 133 Plus Tissue Expander
- K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
- K150481 — Cascadia Interbody System
- K150648 — Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
- K151117 — Laparoscope Lens Shield Device
- K151153 — Pirouette 018
- K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- K151341 — Turbo High-Flow Non-coring Needle
- K151346 — Frontier Medical Devices Posterior Cable Screw System
- K151741 — HA Minuteman G3 MIS Fusion Plate
- K152186 — HealthMyne PACS
- K150220 — STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
- K150519 — ManipulatOR PRO, ManipulatOR
- K151180 — ScandiDos Delta4 Phantom+
- K151371 — Corporate Dental Imaging (CDI) Application
- K151837 — CS 3D Imaging
- K151998 — TraceIT Tissue Marker - 3mL
- K152033 — Cook ECM Powder
- K152209 — FUJIFILM SonoSite X-Porte Ultrasound System
- K143289 — NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
- K143729 — SterilContainer S
- K150311 — Full Automatic (NIBP)Blood Pressure Monitor
- K150621 — OsteoSelect PLUS Demineralized Bone Matrix Putty
- K151009 — Nexus Suture
- K151140 — LnK Lumbar Interbody Fusion Cage System
- K151166 — Instru-Safe Instrument Protection System
- K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
- K151463 — Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
- K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
- K142995 — SOPIX
- K150767 — EDOSE
- K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
- K151332 — Nexus Universal, Nexus Universal Chroma
- K151598 — VesselNavigator Rel. 1.0
- K143538 — MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
- K143613 — PaxWire Occlusion Balloon System
- K150043 — Transcutaneous Electrical Nerve Stimulators (TENS)
- K150169 — Sertera Biopsy Device
- K150432 — IDODENTINE DISC, IDODENTINE BLOCK
- K150728 — XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
- K150810 — Vyntus / SentrySuite Product Line
- K150857 — Banana Gold
- K151172 — MASTERGRAFT Contain
- K151309 — Wartie Advanced Wart Remover or other proprietary name
- K151372 — Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
- K152044 — Flexor Radial Hydrophilic Introducer Access Set
- K143233 — Mitsar-EEG
- K143446 — Accu-Chek FlexLink Plus infusion set
- K143458 — Neurosplint
- K143623 — Narval Brux
- K150452 — ComboCath OTW PTA Dilatation Catheter
- K150584 — Stryker Suture Tape
- K150695 — Modpod
- K150703 — CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
- K150847 — Foundation Interbody Devices
- K151056 — Aesculap T-Space PEEK and XP Spinal System
- K151142 — IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
- K151200 — STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K151277 — Airlock® osteosynthesis plate system
- K151316 — U2 Hip Stem, Ti Porous Coated, Matrix
- K151379 — Conventus PRS System
- K151380 — syngo.via RT Image Suite
- K151448 — Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
- K151533 — Respiratory Gating for Scanners
- K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
- K151702 — Reusable Full Silicone Cover
- K151801 — Arc Endocuff Vision
- K151981 — Turnpike catheter
- K150564 — Spaulding Electrocardiograph 2100iQ
- K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
- K151256 — Arthrex BioSync® Bone Wedge
- K151407 — RECON system
- K151462 — SI-TECHNOLOGY® SI-DESIS® SCREWS
- K151663 — RS80A Diagnostic Ultrasound System
- K151776 — Central Venous Pressure System
- K151859 — Synapse Cardiovascular
- K151929 — PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
- K151935 — Alere Signify H. pylori Whole Blood, Serum, Plasma +3 more
- K151947 — LightSheer Desire Light Laser System
- K142765 — TM SAFETY NEEDLE
- K143148 — Disposable Pressure Manometer (DPM)
- K143583 — Cathivex ¿GV filter units
- K150745 — syngo.CT Single Source Dual Energy
- K150757 — syngo.CT Dual Energy
- K151850 — McKesson Cardiology
- K141594 — Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
- K150395 — Omega LIF System
- K150814 — Straumann Screw-Retained Abutment
- K150928 — Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
- K151057 — WASTON Metallic Bone Plate and Screw Systems
- K151216 — Everest Spinal System
- K151247 — NC Straumann Screw Retained Abutments
- K151264 — Restoration Anatomic Shell
Data sourced from openFDA. This site is unofficial and independent of the FDA.