FDA 510(k) clearances — page 352
clearances on record, most recent first.
Clearances — page 352
35,101–35,200 of 175,770- K150490 — UnicLine Mobile
- K150714 — SI-BONE iFuse Implant System
- K133002 — i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
- K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
- K142551 — QANS (Quantitative Autonomic Nervous System) Monitoring System
- K143405 — Option (TM) ELITE Vena Cava Filter 100cm System
- K143416 — SOMATOM Definition Flash (VA48)
- K143506 — BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)
- K143536 — Voyant Fine Fusion Device
- K143592 — GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
- K150326 — PicoWay Laser System
- K150428 — Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
- K150473 — FlexPointer 1.5 mm
- K150660 — Alcyone MEMS Cannula (AMC) System
- K150860 — Nitroglycerin Sets with DUO-VENT Spike
- K141888 — RUSCH ENDOBRONCHIAL TUBES
- K141914 — PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
- K142519 — InterActive Complete Surgical Tray
- K143591 — Dorsal Appliance
- K150293 — EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
- K141047 — LC CALCIUMHYDROXIDE LINER
- K141324 — HONGYU DISPOSABLE SURGICAL DRAPES
- K142824 — LX-100 Hair Growth Stimulation System
- K143265 — Acrylic Block
- K143269 — Delivery Analysis
- K143332 — Fast Sphyg by Koven
- K143333 — Revital-Ox RESERT Solution Test Strip
- K143664 — HeartSee
- K143731 — IMPLANET Spine System (ISS)
- K143744 — MicroCross Catheter
- K150072 — TheyFit Male Condom
- K150083 — Sidecar External Working Channel
- K150746 — JUSHA-M52C Medical Display
- K142208 — Monopolar Laparascopic Accessories
- K142445 — PINPOINT GT SAFETY INTRODUCER NEEDLE
- K142473 — Lubricating Jelly
- K142647 — mint Lesion
- K142687 — Pulse Oximeter
- K143241 — MDT Navigable Brain Biopsy Cannula
- K143327 — Neoss Ti Reinforced Membrane
- K150065 — SoundCure Serenade Tinnitus Treatment System
- K150132 — IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
- K150516 — DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K150705 — FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
- K150732 — Diamondback 360 Peripheral Orbital Atherectomy System
- K133697 — BREAST-MED TISSUE MARKER
- K140360 — HEALTH KIOSK
- K141349 — Disposable sterile needle retractable safety syringe
- K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
- K142094 — COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
- K142262 — AUTION CHECK PLUS
- K142456 — GPS Spacers
- K142911 — ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K143675 — FORE-SIGHT Elite Absolute Tissue Oximeter
- K143706 — FortiBridge Anterior Cervical Plate System
- K150204 — DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
- K150302 — PROFEMUR Preserve Classic Stem
- K150457 — AlfaSight 9000 Thermographic System
- K150821 — MDNG-3220 (Nio 3MP LED)
- DEN140039 — NOVA View Automated Fluorescense Microscope
- K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES
- K142056 — LIOLI IOL DELIVERY SYSTEM
- K142330 — Kobold Ring and Tandem Applicator Set
- K142421 — G-scan Brio
- K142581 — APTUS Foot System
- K143008 — Vantage Titan 3T
- K143253 — O-MAR
- K143255 — Prelude SNAP Splittable Sheath Introducer
- K143258 — PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)
- K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector
- K143465 — MASTERmatic LUX
- K143610 — BD INTIMA II CLOSED IV CATHETER
- K143659 — Equinoxe Mega Prosthesis
- K143702 — Arthrex Blunt Tip Screws with Fiber Tape
- K143723 — SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
- K150098 — LightStim Professional 2-Panel Light
- K150183 — ApexM
- K150292 — Chocolate PTCA Balloon Catheter
- K150331 — 18ch T/R Knee Coil
- K150567 — MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
- K150607 — Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
- K133033 — HIDREX PSP1000
- K141737 — CONVENTUS PHS SYSTEM
- K143019 — CD HORIZON Spinal System, IPC POWEREASE System
- K143374 — BLUEPRINT Patient Specific Instrumentation
- K143400 — SOMATOM Definition AS/AS+
- K150051 — Exilite
- K150155 — NOVA Lite DAPI ANA Kit
- K150506 — ELIAN Digital Diagnostic X-ray System
- K150634 — AngioSculpt PTA Scoring Baloon Catheters
- K150647 — Polyscrew Pedicle Screw System
- K143249 — SOLSTICE OCT System
- K150172 — ACCLARENT SE Inflation Device
- K150229 — SOLSTICE OCT System
- K150580 — UltraVision 2 Diagnostic Ultrasound System
- K150602 — CR3 Keyless Split Sample Cup Morphine - Methamphetamine
- K140233 — ULTRASONIC SCALER
- K141619 — LUOFUCON SILVER FOAM DRESSING
- K141913 — PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
- K142740 — Ziehm Vision RFD 3D
Data sourced from openFDA. This site is unofficial and independent of the FDA.