FDA 510(k) clearances — page 290
clearances on record, most recent first.
Clearances — page 290
28,901–29,000 of 176,542- K160850 — Nucleoss Tpure Implant System
- K163251 — Life Essence Universal Porcelain System
- K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N)
- K170861 — Premier
- K171147 — REVEAL Bulk
- K171345 — Cellvizio 100 Series Systems with Confocal Miniprobes
- K171366 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
- K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
- K172081 — Maestro Microcatheter
- K161358 — Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
- K162507 — Arzzt 3.5 / 4.5 Small & Large Fragments System
- K162744 — Everyway OTC EMS, Model EV-805
- K170919 — The TiBow Expandable Spacer System
- K170928 — CADence System
- K171164 — U-Lite EXP
- K171322 — eCareManager 4.1
- K171356 — Clarity Reveal
- K171390 — dpl II Panel
- K171456 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K172036 — Medrobotics Flex Robotic System
- K172039 — CATHTONG II PICC Catheter
- K162832 — 731 Series Ventilators
- K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
- K170651 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
- K170712 — Accutorr 7/VS-900 Vital Signs Monitor
- K171038 — Hearing Healthcare Pro
- K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored
- K171595 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K171717 — AUTOCON III 400
- K172004 — truSculpt
- K170285 — AED Sinuscope
- K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
- K170885 — DD cubeX2 HS
- K170894 — Zirconia Dental Ceramics
- K171062 — BP5S Wireless Blood Pressure Monitor
- K171075 — Calix-C Cervical Interbody Spacer
- K171077 — HEXA100 (hexafocon A) Daily Wear Contact Lenses
- K171079 — Q-Switched Nd:YAG Laser System
- K171315 — Advanced RBC Application
- K171369 — M.U.S.T. MINI Posterior Cervical Screws System
- K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set
- K171639 — Trojan Supra Lubricated Polyurethane Male Condom
- K171758 — M.U.S.T. Combined Set Screws
- K171870 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL
- K171906 — Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
- K171975 — HardyDisk AST Delafloxacin 5 µg (DLX5)
- K161845 — Electronic Blood Pressure Monitor
- K163127 — bellavista 1000
- K163136 — Youha electric breast pump
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K170207 — Obturys
- K170842 — WEGO-PTFE
- K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K171132 — Carefusion NeutraClear Needle-free connector
- K171301 — Scanmate Flex
- K171588 — NuBODY Skin Toning Device
- K171607 — Bronchi and Gastrointestinal Cytology Brush
- K171615 — Xingyu Nitrile Powder Free Patient Examination Gloves, White color
- K171623 — Nasal Pancreatic Drainage Set
- K171999 — Performer Introducer
- K172025 — Litho 60
- K162951 — TUBETECH IV Administration Set
- K163048 — Smart Stitching Software System, Image Processing, Radiological
- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K163259 — AXS Offset Delivery Assist Catheter
- K163352 — Wheelchair
- K163633 — cobas HbA1c Test, cobas b 101 system
- K170187 — Photodynamic Therapy Device
- K171054 — Biomet Knee Joint Replacement Prostheses
- K171103 — Lumipulse G TSH-III Immunoreaction Cartridges
- K171265 — Otowave 302 Portable Tympanometer
- K171602 — Williams Cystoscopic Injection Needle
- K171699 — da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
- K171754 — NovaPACS
- K171945 — Discovery Pico, Discovery Pico Plus
- K172013 — VitalBeam
- DEN150053 — FETAL PILLOW
- K162816 — SML-OSA2 Appliances
- K163005 — TIGR Matrix Surgical Mesh
- K163031 — Bunegin-Albin Air Aspiration Set
- K163597 — VacLok AT Vacuum Syringe
- K170313 — ARIX Ankle Distal Tibia System
- K170563 — 3M Comply Hydrogen Peroxide Indicator Tape
- K171282 — Fully Automatic Blood Pressure Monitor
- K171423 — Nasal Alar SpO2 Sensor
- K171905 — VISCO 360 Viscosurgical System
- K172041 — truFreeze System
- K162867 — MagDen Dental Implant System
- K163400 — Orbit Inserter
- K163536 — MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
- K170769 — wireless thermometer
- K170812 — HygePLUS Alginate Impression Material
- K170841 — BiopSee, Mobile US
- K171515 — NHAC 16
- K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution
- K162312 — Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
- K163062 — PHMB Antimicrobial Foam Wound Dressing
- K170067 — Easyret
- K170073 — LightMed Dental Laser System
- K170305 — Spinal Manometer NRFit; Spinal Manometer LUER
Data sourced from openFDA. This site is unofficial and independent of the FDA.