FDA 510(k) clearances — page 325
clearances on record, most recent first.
Clearances — page 325
32,401–32,500 of 176,542- K160681 — CenterCross Ultra Catheter
- K161003 — EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
- K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
- K161045 — Monoject
- K161280 — Cervical Stand Alone System
- K161364 — BinaxNOW G6PD Test
- K153076 — silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
- K153391 — Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
- K153632 — Endoform Reconstructive Template
- K160071 — StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
- K160350 — ECG CT Gating Device
- K160645 — PreSep Oligon Oximetry Catheter
- K160795 — United Urologics Intermittent Catheter
- K160819 — Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- K152688 — LightLas Multi-Wavelength Medical Laser System
- K153496 — Disposable Surgical Face Mask
- K153607 — ROMA Calculation Tool Using Elecsys Assays
- K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
- K160498 — Dentivera Milling Disc
- K160539 — BiZact Open Sealer/Divider
- K160738 — ZUK Select Knee System
- K160821 — Tria Sapphire
- K161342 — Sonic Window
- K161346 — NormaTec PCD-T and PCD-B
- K151985 — PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
- K153456 — Megapulse III Shortwave Diathermy
- K160238 — Airborne Phototherapy Light
- K160625 — Disposable Hot Biopsy Forceps
- K160627 — Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution
- K160717 — ally Warming Liquid Personal Lubricant
- K160751 — Symphion Endoscope and Symphion Cervical Sheath
- K161156 — Full Automatic (NIBP) Blood Pressure Monitor
- K161362 — ASAHI Corsair Armet
- K161366 — ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
- DEN150007 — Magnetic Surgical System
- K153702 — M3290B Philips IntelliVue Information Center iX
- K160018 — Arrow Quickflash Arterial Catheterization Device
- K160729 — Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
- K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
- K161035 — Medline Singe Patient Use Blood Pressure Cuff
- K161062 — NR Recorder
- K160739 — Cranial COVER
- K161064 — Penumbra System ACE 68 Reperfusion Catheter
- K152251 — Endobronchial Tube
- K152744 — DIEGO ELITE DRILL
- K152747 — DSG Threaded Drill System
- K153434 — Pall-Aquasafe Water Filter
- K153659 — MaxO2ME
- K160095 — Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
- K160364 — VersaWrap Tendon Protector
- K160496 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K160555 — BLUEPRINT Patient Specific Instrumentation
- K160700 — ATTUNE Revision Knee System
- K160703 — NeuroStar TMS Therapy System
- K160975 — Aequalis PerFORM+ Shoulder System
- K160995 — NEOVIEW Plating System
- K161363 — Arsenal Spinal Fixation System
- K152011 — Lucent Intervertebral Body Fusion Device
- K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
- K152667 — ATOVEN-Reusable Laser Fiber
- K160204 — BSD4343 Digital Flat Panel X-ray Detector
- K160370 — BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
- K160510 — MAKO 7
- K160526 — Masimo O3 Regional Oximeter System
- K160546 — 3M Attest Rapid Readout Biological Indicator
- K160587 — Aquilion ONE (TSX-305A/3) V7.3
- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K160989 — NuVasive® Reline® System
- K161001 — MILAGRO ADVANCE PEEK Interference Screw
- K161180 — Oak Ridge Products Sharps Containers
- K161188 — HEPATIQ 1.1
- DEN130051 — PEDIATRIC VISION SCANNER
- K152597 — ProteXsure Safety Capsule System
- K153181 — MAIA
- K160400 — Miromatrix Biological Mesh
- K161122 — Sony IP Converter NU-IP40S
- K151137 — X-VIEW, IMAGEN
- K151250 — Smart Set
- K152786 — A Plus Internal Fixture System
- K152877 — SureFine Pen Needle
- K153388 — IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
- K153713 — Getinge Series Warming Cabinet
- K160005 — Contact Lens Case (multiple brand name)
- K160232 — Disposable Barrier Sleeves and Covers
- K160474 — DSM Biomedical Porcine Pericardium Dental Membrane
- K161147 — EndoCure Model EUR078A
- K161297 — Beta-2-Microglobulin
- K142130 — ORAL BOND
- K151239 — NMI DUAL PORT II
- K152729 — MICROPERIMETER MP-3
- K153436 — LATERAL Spine Truss System
- K153534 — NobelProcera HT ML Full Contour Zirconia Crown
- DEN150040 — WallFlex Biliary RX Fully Covered Stent System RMV
- K152276 — Wing Smart FEVI and Peak Flow Meter
- K152301 — Background Pattern Classification [BPc(TM)]
- K152521 — Seal Rite Non-Rebreathing Valve
- K152561 — Communicator Surgical Facemask with Clear Window
- K152893 — Corin Optimized Positioning System (OPS)
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
- K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
Data sourced from openFDA. This site is unofficial and independent of the FDA.