FDA 510(k) clearances — page 327
clearances on record, most recent first.
Clearances — page 327
32,601–32,700 of 176,542- K152423 — Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
- K152507 — Dr. Wolff Vagisan Moisturising Cream
- K152559 — TruAbutment DS
- K153127 — everX Posterior
- K153334 — Oral-B 5% Sodium Fluoride Varnish
- K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports
- K153650 — Microdent Ektos Implant System
- K160052 — CUR Model 1
- K160065 — GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
- K160091 — Temperature Probe, Affinity Temperature Probe
- K160152 — Trillium Oval V 5.1 MRI System
- K160289 — MasterLoc Stem
- K160416 — CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
- K160463 — Reliance Lumbar IBF System
- K160506 — Planmeca ProMax 3D Max, Planmeca Maximity
- K160810 — ViZion DR + Wireless
- K160877 — United Urologics Closed System Catheter
- K160889 — BIB Stent Placement Catheter
- K161123 — Baha 5 Power Sound Processor
- K161140 — VITROS Chemistry Products Calibrator Kit 3
- K150553 — Filbloc
- K152452 — Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
- K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
- K153107 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
- K153264 — EasyPass Guidewire
- K153658 — Target Detachable Coils
- K153778 — Nester Embolization Coils, Tornado Embolization Coils
- K160290 — Valleylab REM Polyhesive Infant Patient Return Electrode
- K160342 — EMPOWR PS Knee System
- K160403 — SmartStart Air/Water and Suction Valves
- K160537 — Navio
- K160994 — C2 CryoBalloon Focal Pear Catheter
- K161041 — OsteoMed ExtremiLOCK Wrist Plating System
- K161102 — Nanostim Introducer Kit
- K161125 — OptiCross X, 40 MHz Coronary Imaging Catheter
- K153663 — Vario 8/18/ci
- K160226 — JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
- K160332 — Stryker SDC3 HD Information Management System with Wireless Device Control Capability
- K161229 — Mammo Tomosynthesis (MDMG-5221)
- K152062 — BIOFOAM Bone Wedge
- K152657 — SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
- K153331 — SafeCT-29
- K153553 — SiO2 Coated syringe 3 ml
- K153716 — GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
- K160356 — Third Eye Panoramic Auxiliary Endoscopy System - Resposable
- K160480 — PicoSure Workstation
- K161080 — Escalade Legend Acetabular Shell
- K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
- K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
- K153396 — Aesculap OrthoPilot Next Generation
- K153683 — Trak Male Fertility Testing System
- K160090 — Lumipulse G ROMA
- K160280 — MagPro R20
- DEN140032 — Cereve Sleep System
- K152020 — Bindex BI-100
- K152068 — Astral 100/150
- K152353 — SeraQuest HSV Type 2 Specific IgG
- K152510 — UltraCor Twirl Breast Tissue Marker
- K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
- K153236 — Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
- K153490 — DD medical polymers
- K153563 — AirFit F20
- K160057 — ArcCHECK-MR
- K160154 — ALTA Anterior Cervical Interbody Spacer
- K160240 — Perimeter Otis 1.0 Optical Coherence Tomography System
- K160380 — LT-300 HD
- K160710 — Oasis Lacrimal Intubation Set
- K161057 — Diagnostic Imaging Color LCD Monitor
- K161117 — EzDent-i / E2 / Prora View
- K161119 — SonoSite iViz Ultrasound System
- K150980 — Venous Assist System
- K152630 — VERIFY STEAM Integrating Indicator
- K152745 — ReNew Sterilization Trays(Catalog #3708 and #3709)
- K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
- K153239 — LSFG-NAVI
- K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
- K153670 — Genteel Lancing Device
- K153703 — Guiding Catheter
- K160254 — GORE DrySeal Flex Introducer Sheath
- K160419 — Monoject Enteral Feeding Syringe with ENFit Connector
- K161046 — Laser Helmet LH40-EVO
- K152429 — Slit Lamp Microscope
- K152443 — Vericore Gradient Temporary Disc
- K152825 — Catalyst CSR Shoulder System
- K161000 — Biodesign Otologic Repair Graft
- K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
- K153657 — Vanguard XP Knee System
- K160242 — Reprocessed Livewire Steerable Diagnostic EP Catheter
- K160303 — Reprocessed Polaris X Steerable Diagnostic EP Catheter
- K160319 — FiberTak DR
- K152431 — LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
- K153350 — IBS Implant System
- K161017 — True HD 3MOS Camera System
- K152043 — Diagnostic Station DS20
- K152205 — Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
- K152415 — Digital Blood Pressure Monitor
- K152680 — TD-1035 Thermometer
- K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
- K152769 — FREMAP ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.