FDA 510(k) clearances — page 359
clearances on record, most recent first.
Clearances — page 359
35,801–35,900 of 176,542- K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
- K150777 — Artoura Breast Tissue Expander
- K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
- K150798 — Codent Low Speed Dental Handpieces and Accessories
- K150843 — syngo®.via (version VB10A)
- K140348 — INTERBODY CAGE
- K141362 — PULSE OXIMETER CMS50EW
- K142141 — STARBAND, STARLIGHT
- K142253 — SOLSTICE OCT System
- K142282 — HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
- K142535 — ConMed Mixing and Delivery Kit
- K142817 — IntraNovo 25 Microcatheter
- K142926 — iBreastExam
- K143252 — Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
- K143280 — BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
- K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
- K143666 — Noblex Long Pulse Alexandrite Laser
- K143684 — NuVasive Reline System
- K150103 — Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
- K150110 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
- K150163 — Otowave 202 Portable Tympanometer
- K150182 — Neodent Implant System- CM Drive Implants
- K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter
- K150583 — Aequalis PerFORM+ Shoulder System
- K150656 — PRECICE Intramedullary Limb Lengthening System
- K150993 — NICO TRIOwand
- K141770 — LUNA CPAP AND AUTO-CPAP SYSTEM
- K141999 — ADVIA CENTAUR TSH
- K142058 — RAYSCAN A-EXPERT
- K143034 — Jintronix
- K143363 — VENUS Spinal Fixation System
- K143541 — Relieva SpinPlus Balloon Sinuplasty System
- K150108 — Reverse Medical Micro Vascular Plug System
- K150235 — CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
- K142216 — Tranberg CLS Thermal Therapy System
- K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- K143312 — Portrait GBS Assay
- K143341 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K143574 — Melodi Prime Breast Pump
- K150134 — Basic, Dominant Flex, KV-6
- K150499 — Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
- K132663 — I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
- K141747 — RHINOGUARD
- K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP
- K142506 — TensCare KegelFit
- K143016 — Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
- K143140 — G-Premio BOND
- K143440 — Natus Quantum
- K143527 — IPM Wound Gel Bio, IPM Derm Gel Bio
- K143739 — POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
- K150033 — Air Compressible Limb Therapy System
- K150133 — PROFEMUR Preserve Size 1-3 Hip Stems
- K150212 — DeScribe Transparent PFD Patch
- K150897 — Tosama 100% Cotton Menstrual Tampon
- K140453 — OSTEOTEC SILICONE FINGER IMPLANT
- K140506 — JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
- K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
- K142083 — TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
- K142149 — OXYTOTE INFINITY SERIES VIPR SYSTEMS
- K142186 — DIODE LASER HAIR REMOVAL SYSTEM
- K142247 — RAYSCAN A-EXPERT 3D
- K142779 — SCANIP; SCANIP: MEDICAL EDITION
- K142883 — MindChild Meridian M100 Fetal Heart Rate Monitor
- K142930 — Exam Vue DR
- K142986 — SagiNova
- K143447 — Dilapan-S
- K143599 — Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
- K150104 — Vitrea CT Myocardial Perfusion
- K150191 — GammaBeam 500
- K150416 — ProCinch Adjustable Loop Device
- K150427 — Vantage Titan 1.5T, V3.1, MRT-1510
- K150430 — Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
- 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) +6 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.