FDA 510(k) clearances — page 335
clearances on record, most recent first.
Clearances — page 335
33,401–33,500 of 175,770- K151361 — Nox RIP Belts & Cables
- K151609 — ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
- K151713 — LILLIPUP PMP, LILLIPUT PMP INTEGRATED
- K151759 — Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
- K151903 — Slendertone connect Abs
- K151925 — Elation Wireguided Balloon Dilation Catheter
- K151928 — PUR Dental Implant System
- K152203 — UTERMOHLEN CRYO PROFESSIONAL
- K152567 — Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
- K153023 — Ablatherm Integrated Imaging
- K150102 — SnoreSounds
- K150219 — Equashield Closed System drug Transfer Device (CSTD)
- K150329 — elance Vital Signs Monitor, Central Monitor Software
- K150386 — Tyece OTC TENS Device
- K150688 — IdentEvent
- K150963 — AnsCare ChitoClot Pad
- K151080 — Nihon Kohden CSM 1901 Bedside Monitor
- K151376 — superDimension Navigation System
- K151432 — NaturalLine Abutment
- K151632 — Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
- K151901 — AirView
- K152138 — FDR D-EVO GL Flat Panel Detector System
- K152248 — CD HORIZON Spinal System
- K152256 — RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
- K152923 — BD ChloraShield IV Dressing with CHG Antimicrobial
- K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K143497 — Safety Auto-Disable Syrine with Needle (Auto-Lock)
- K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
- K151212 — Ziostation2
- K151383 — NeuViz 128 Multi-slice CT Scanner System
- K152236 — KATOR Suture Anchor
- K151019 — SternaLock® 360 Sternal Closure System
- K152295 — Talon DistalFix Antegrade/Retrograde Femoral Nail
- K152580 — rescuenet
- DEN150008 — INVOcell
- K142941 — Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
- K143584 — PGA RESORBA, PGA RESOQUICK, GLYCOLON
- K150713 — syngo.CT Myocardial Perfusion
- K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
- K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
- K151872 — Avance Y-Connector S
- K151992 — FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
- K152183 — EXELINT SecureTouch Safety Hypodermic Needle
- K152570 — Bovie J-Plasma Precise 360 Handpiece
- K152592 — PROBEAT-V
- K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
- K152962 — HS70A Diagnostic Ultrasound System
- K142410 — Elliquence Electrodes
- K143420 — SYMBIS Surgical System
- K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
- K150462 — Vera
- K150595 — SCENARIA Phase 3 Whole-body X-ray CT System
- K151109 — Lumenis Smart532 Laser System
- K151283 — Lung Analysis Software
- K151366 — Philips CS770 IntelliSpace Critical Care and Anesthesia
- K151531 — MasterLoc Stem
- K151619 — Prime&Bond Elect Universal Dental Adhesive
- K151788 — Cardinal Health Sterilization Wrap
- K151886 — Acumed Ankle and Small Fragment Base Set Update
- K151888 — Frontier Medical Devices In-line Orthopedic Cable Cerclage System
- K152040 — X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
- K152273 — Cosmedico Ultraviolet Lamps of Various Models
- K152312 — RECON system-V-TEK-IVP Plates and Screws
- K152357 — MicroSTAAR Injector System Cartridges
- K152381 — Prelude SNAP Splittable Hydrophilic Sheath Introducer
- K152481 — DURAFORM Dural Graft Implant
- K152899 — Philips Lumify Diagnostic Ultrasound System
- K141854 — INSTRUMENT CASSETTE (EFCCL1-F)
- K143117 — Wire Sterilization Package with Indicators
- K143582 — MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
- K143716 — DSM Biomedical DPR Cable
- K143727 — PENTAX Medical EKP-i5010 Video Processor with EB Family
- K150523 — AVAmax Vertebral Balloon
- K150568 — ARROW Humeral stems size 6 and 16
- K151159 — Leksell Gamma Knife Perfexion
- K151456 — Small Bone Nail Implant
- K151715 — T3 Software
- K151718 — iFuse Implant System
- K151758 — ALAR Nasal Valve Stent
- K151875 — Pavati Zirconia
- K151894 — IPS Ivocolor
- K151971 — STERRAD CYCLESURE 24 Biological Indicator
- K152008 — Physica PS Knee System
- K152120 — OPTIS Mobile System
- K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
- K152159 — Oravan Herbst
- K152367 — Optiflux dialyzer
- K152465 — Disposable Blood Pressure Cuff
- K152468 — Reusable Blood Pressure Cuff
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
- K152543 — M9/M9CV/M9T Diagnostic Ultrasound System
- K152605 — Impulse Angiographic Catheter, Expo Angiographic Catheter
- K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
- K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
- K151535 — Cavex Cream Alginate
- K151723 — Rainbow Trans
- K152039 — Genesys Spine TiLock2 Spinal System
- K152095 — Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
- K152124 — Tempus IC2
- K152204 — VS3-IR system
Data sourced from openFDA. This site is unofficial and independent of the FDA.