FDA 510(k) clearances — page 351
clearances on record, most recent first.
Clearances — page 351
35,001–35,100 of 175,770- K150283 — Republic Spine Dark Star Spinal System
- K150456 — Arthrex Plates, Screws, and Staples
- K150520 — DARCO Locking Bone Plate System
- K150579 — Cardinal Health External Fixation System
- K150633 — ULTRA Telescopes
- K150836 — OUTBACK Elite Re-Entry Catheter
- K150837 — IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
- K150974 — aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
- K142196 — Visage Ease Pro
- K143024 — CAS-One Liver
- K143551 — Compex Wireless USA
- K150045 — S30/S40 Digital Color Doppler Ultraound System
- K150059 — BD FlowSmart Set
- K150223 — Facet-Link Stabilization Platform
- K150254 — Streamline OCT Occipito-Cervico-Thoracic System
- K150460 — KYPHON (R) HV-R(R) Bone Cement
- K150842 — JUSHA-M53 Medical Display
- K150286 — Medline Enteral Feeding Sets
- K141482 — KI-20
- K141643 — YARLAP
- K142061 — SILHOUETTE INSTALIFT
- K142371 — Luminesse PMMA
- K142624 — Neuromaster G1 MEE200
- K142909 — Flexible 19G EBUS Needle
- K142918 — EndoTool SubQ
- K143238 — C3 Wave
- K143530 — Aespire View
- K143741 — Lipofina Laser System
- 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; SCANIP: MED
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.