FDA 510(k) clearances — page 316
clearances on record, most recent first.
Clearances — page 316
31,501–31,600 of 175,699- K161146 — Radixact Treatment Delivery System
- K161164 — CareEvent inclusive of the CareEvent Mobile Application accessory
- K161421 — Single Use Surgical Suction Irrigator
- K161476 — SMR Shoulder System
- K150404 — QiF Blood and Fluid Warmer
- K152600 — Collagen Dental Wound Dressings
- K152937 — EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
- K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
- K153018 — CELALUX 3
- K153057 — FitRite Total Hip Arthroplasty System
- K153353 — SANDMAN ELITE
- K153472 — Quiver Laparoscopic Extendable
- K153682 — Chocolate XD PTCA Balloon Catheter
- K160156 — StatStrip Xpress Blood Glucose Monitoring System
- K160169 — The Life Spine Subtalar Implant System
- K160468 — Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
- K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
- K160602 — JustRight Surgical Vessel Sealing System
- K160805 — NIO-P
- K160823 — NC Quantum Apex PTCA Dilatation Catheter
- K161191 — Latera Absorbable Nasal Implant
- K161559 — Kuvia3D
- K152863 — Portable ECG Monitor
- K152967 — NERBRIDGE
- K153545 — Portable Slit Lamp
- K153569 — Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
- K160514 — OptiCross 18, 30 MHz Peripheral Imaging Catheter
- K161061 — IMPAX Volume Viewing 4.0
- K161101 — PolypVac Microdebrider (3.3mm and 4.0mm)
- K161325 — CliniCloud Non-contact Thermometer, Model SPL1024
- K161429 — Target Detachable Coils
- K152246 — Aquarius Stoma Measuring Device
- K153106 — ASAHI Fielder XT-A, ASAHI Fielder XT-R
- K153225 — Masimo Root Monitoring System and Accessories
- K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
- K160131 — OEC Elite MiniView
- K160209 — Gold Anchor
- K160213 — s-Clean Tapered II RBM Implant System
- K160334 — Advanced Medical Imaging Software Suite (KSWVWR)
- K160691 — Acne Light Therapy Wand
- K161444 — DBSWIN and VistaEasy Imaging Software
- K152244 — RADspeed Pro
- K152884 — DermaTherapy Bed Linens
- K160170 — Lehman Manometry Catheter
- K160451 — V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
- K160458 — BI IMAGE-X EVOLUTION
- K160525 — RCT700
- K160598 — REBOA Balloon Catheter
- K161134 — Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator
- K152734 — Kerrison Rongeurs
- K152771 — SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
- K153351 — Quantib Brain 1
- K153367 — S698 Symbioz flow
- K153374 — CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
- K153537 — Sol-M Insulin Syringe, Sol-M TB Syringe
- K160265 — Image Navigator by Immuno Concepts
- K160544 — Withings Thermo (Model SCT01)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.