FDA 510(k) clearances — page 156
clearances on record, most recent first.
Clearances — page 156
15,501–15,600 of 176,479- K213308 — Venus BlissMAX
- K213915 — BIB Stent Placement Catheter
- K214012 — Straight Arm DDR
- K191356 — i3 Foldable Mobility Scooter
- K202094 — Cardiovascular Suite 4.2.1
- K211851 — Ora-Aid
- K212591 — Disposable Surgical Gown
- K212735 — Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
- K213102 — ES1 System
- K213168 — Medical Examination Gloves
- K213199 — Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
- K213380 — 360CAS
- K213391 — High Retention Attachment System
- K213942 — Esteya
- K211260 — Sheng Jing Tang Surgical Mask
- K211274 — iQ 2 Nasal Mask, Phantom 2 Nasal Mask
- K211419 — Gingi-Aid Gel
- K212358 — Romero Cervical Cage
- K212505 — DUMI ManipulatOR
- K212541 — 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
- K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
- K212854 — Powered Wheelchair
- K212954 — G-Tech Wireless Patch System (WPS)
- K213111 — MagnetOs granules
- K211666 — Powder Free Nitrile Examination Gloves, Blue Chemotest
- K212801 — Powder free nitrile examination glove- black, non sterile
- DEN210015 — Sunrise Sleep Disorder Diagnostic Aid
- K203360 — EK Implants and Abutments System
- K210039 — CORE1 Implant System
- K210198 — GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
- K210564 — Infrared Thermometer
- K211110 — Agile Devices Angler Steerable, Deflectable Microcatheter
- K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4)
- K211349 — Selebrek PTCA Balloon Dilatation Catheter
- K211443 — AIBOLIT 3D+
- K211716 — DropSafe Safety Pen Needles
- K211742 — SignaSure Dual Mobility System
- K211940 — Fetal Doppler
- K212127 — Picocaremajesty
- K212152 — Prelude IDeal 9F Hydrophilic Sheath Introducer
- K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K212841 — Pectus Blu Support Bar System
- K212980 — Tesera-k ALIF System
- K212990 — Acumed Ankle Syndesmosis Repair System
- K213262 — CELERITY HP Chemical Indicator
- K213570 — Dental Zirconia Ceramic
- K213720 — Vital Navigation System
- K213880 — Custom Stable Rigid Gas Permeable Scleral Contact Lens
- K213901 — Cyclops Anterior Cervical Plate System
- K211135 — Enlight 2100
- K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
- K212468 — Tigereye CTO-Crossing Catheter
- K212797 — iPrime Viscodelivery System
- K212847 — Penta Glove
- K213053 — Gold Anchor
- K213544 — TOMTEC-ARENA
- K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K213839 — DePuy Corail AMT Hip Prosthesis
- K213841 — ENEO TOTALE (Model: ENEOT947)
- K211149 — Urethral Warming Catheter Kit
- K211318 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
- K211978 — Jplant
- K212115 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
- K212609 — BHA100 Series Braun Clear Hearing Aid
- K213019 — Vinyl Exam Gloves
- K213281 — PASS LP Spinal System, CD Horizon Spinal System
- K213342 — PRO-DENSE LoVisc Bone Graft Substitute
- K213344 — BTL-899A
- K213816 — MPO Hip Instruments
- K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments
- K213879 — Self-adhesive Electrode
- K213951 — FORZA XP Expandable Spacer System
- K202994 — InnoClip Disposable Clip Applier, InnoClip Clip Applier
- K203595 — DynaFuse Fixation System
- K211647 — HP358EA Electrically Powered Wheelchair
- K211789 — restor3d Pin Implants
- K212299 — Medical Surgical Mask
- K212375 — Disposable Medical Surgical Mask
- K213080 — T-Edge 10, T-Edge 11
- K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
- K210830 — VUZE System
- K213068 — Medline Smoke Evacuation Shroud
- K213187 — Disposable Nitrile Medical Powder-free Glove
- K203177 — Sterisystem Dry-Base Instrument Tray
- K202898 — Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
- K211159 — eco-x Series (eco-x, eco-x-s)
- K211263 — Intrelief
- K211458 — Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
- K212547 — Quick-Start Screws
- K212834 — Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
- K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
- K211156 — CONVIVO In Vivo Pathology Suite
- K212656 — Flexible Intubation Video Endoscope Sterile (FIVE-S)
- K213073 — Goody Gloves, Wincare, TBG Gloves
- K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
- K213776 — LiverSmart
- K212806 — Alcon (serafilcon A) soft contact lenses for daily wear
- K213016 — ATM Glove
- K213209 — EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.