FDA 510(k) clearances — page 321
clearances on record, most recent first.
Clearances — page 321
32,001–32,100 of 176,542- K160563 — Fully Automatic Electronic Blood Pressure Monitor
- K160685 — Surveyor S4 Mobile Monitor
- K161006 — Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- K161286 — IPL Therapy Machine
- K161387 — Mont Blanc and Mont Blanc MIS Spinal Systems
- K161798 — FacetBRIDGE® System
- K161986 — SIDEKICK and USHER Support Catheters
- K151542 — A-Oss
- K151750 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
- K151757 — IMMEDIATELOAD Dental Implant System
- K160219 — Hilal Embolization MicroCoils
- K160284 — JointPoint
- K160636 — iPEP System and vPEP
- K160774 — IonoStar Plus
- K161033 — AFX Femoral Implant With Inserter
- K161234 — CASSI II Rotational Core Biopsy System
- K161289 — DURAFIBER Ag
- K161505 — DyeVert NG Contrast Modulation System
- K151824 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
- K160467 — Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K160542 — 5.0 Fr Arndt Endobronchial Blocker Set
- K160675 — Powder free vinyl patient examination glove, colored (yellow)
- K161220 — ARIES® Flu A/B & RSV Assay
- K161409 — M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
- K161864 — ARIX Foot System
- K161896 — Biomet Microfixation Sternal Closure System
- DEN140040 — Nautilus BrainPulse 1000
- K153065 — The Hammertoe Correction System
- K153205 — IDSS ForceTriad Control Module
- K153352 — Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
- K160275 — Fuse Endoscopic System with FuseBox Processor
- K160414 — Precision Point Biopsy Needle Guide
- K160664 — Aqueduct 100 Cervical Dilator
- K160699 — VIRTU Lumbar Spacer System
- K160856 — SpineView X-Pac Expandable Lumbar Cage System
- K160932 — 8ch Foot Ankle Coil
- K160937 — Senolris
- K160938 — SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
- K160999 — Infra-red forehead thermometer
- K161199 — EndyMed Contour Handpiece
- K160961 — Mozec NC-Rx PTCA Baloon Dilatation Catheter
- K161427 — Pirouette 035
- K152087 — HeatLux Pro II
- K153296 — MEDINAUT Kyphoplasty System
- K153493 — Clip Flow
- K153732 — Powder Free Blue Nitrile Examination Glove
- K160038 — UniStrip1 Generic Blood Glucose Test Strips
- K160082 — Puritan Opti-Tranz Cary-Blair Collection and Transport System
- K160107 — DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
- K160256 — Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
- K160477 — The Luco Hybrid OSA Appliance
- K161058 — Cannulated Screw
- K161256 — TheraCem
- K161499 — VertiForm Posterior Fixation System
- K161507 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
- K161563 — Allura Xper FD series and Allura Xper OR Table series
- K161627 — PASS LP Spinal System
- K161801 — CrossCath Support Catheter
- K161839 — 2D Quantitative Analysis
- K161849 — Bright
- K152099 — Genesys Spine Apache® Anchored Cervical Interbody Fusion System
- K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- K160192 — Atteris Antimicrobial Skin & Wound Cleanser
- K160339 — Cardinal Health Isolation Gown
- K160465 — Spinal Elements' Spinous Process Plate System
- K160747 — Angel Catheter
- K160863 — PBS(-), Phosphate Buffered Saline
- K160910 — Elecsys Syphilis
- K160935 — 8ch Foot Ankle Coil
- K161008 — POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
- K161020 — XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
- K161118 — SIMPLANT Online Case Review and SIMPLANT Editor
- K161382 — LVivo Software Application
- K161509 — 3D OCT-1 Maestro
- K161631 — MAMMI
- K161669 — Waterlase Express
- K161771 — Medilas H Laser Fibers
- K161787 — ACUSON NX2 Diagnostic Ultrasound Systems
- K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- DEN150029 — Permaseal
- K151424 — The Progressive Orthopaedic Total Hip System
- K152385 — Zeramex P6 Dental Implant System
- K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
- K153484 — Dillard Airway Dilatation System
- K160101 — SinuBand
- K160367 — Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K160385 — Precision Screw
- K160596 — BEAUTIFIL II LS
- K160755 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K160893 — HANAROCare ReJu
- K161817 — Tina-quant Cystatin C Gen.2
- K153010 — Hudson RCI AquaPak Sterile Prefilled Nebulizers
- K153070 — Watch-PAT200U
- K153124 — DuraLazeTM HoLEP Laser Fiber
- K153363 — Red2Green Reusable Sharps Container
- K160629 — InPen
- K160684 — Atteris No-Sting Skin Protectant
- K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
- K160813 — EasyStep
Data sourced from openFDA. This site is unofficial and independent of the FDA.