FDA 510(k) clearances — page 308
clearances on record, most recent first.
Clearances — page 308
30,701–30,800 of 175,699- K161379 — ELSA Spacers
- K161424 — Phasix Mesh
- K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
- K161672 — SpeediCath Flex Coude
- K162059 — EZEE RETRIEVAL
- K162126 — Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
- K162332 — Nexcore GI Insufflator
- K162416 — IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
- K162426 — nva, nvp, and nvt
- K153546 — PINK CAD/CAM disc
- K160136 — Flowable Wound Matrix
- K160365 — BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
- K161002 — Aprima Smartesis Centesis Pump
- K161014 — NuVasive® Reline® System
- K161173 — Avenue® T TLIF Cage
- K161442 — NuVasive® CoRoent® Small Interlock System
- K161562 — Sound Options Tinnitus Treatment
- K162417 — Acuson Freestyle Ultrasound System
- K152865 — TRACOE smart Cuff Manager
- K160630 — Invacare Platinum Mobile Oxygen Concentrator
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160825 — MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
- K160957 — CDB Self Ligating Bracket 8F
- K161446 — Biopor Porous Polyethylene Implants
- K161814 — Solana Influenza A+B Assay
- K161984 — Interlocked Circular Small Field Collimators, Elekta Integrated
- K162107 — TPH Spectra+ Universal Composite Restorative
- K162307 — OrthoPediatrics Locking Proximal Femur System Cortical Screws
- DEN150033 — Sensor Monitored Alimentary Restriction Therapy (SMART) Device
- K160167 — DePuy Synthes TFNA Augmentation System
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
- K160945 — Endophys Blood Pressure Monitor
- K161185 — LUCERNA Dental Laser
- K161506 — Penumbra Aspiration System
- K161825 — PK AIM
- K161838 — Xenocor Xenoscope Laparoscopic System
- K161878 — PORTAGE System
- K151285 — VSP Cranial System
- K160640 — PASS XS Spinal System
- K160657 — BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
- K160880 — Photonica Professional
- K161832 — O2VENT T
- K161945 — EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
- K162143 — FixxSure® X-Link
- K153565 — DONASORB SILVER WOUND DRESSING
- K153761 — Emergency Transtracheal Airway Catheter
- K160015 — Pure Vu
- K160860 — MiniMed Quick-serter
- K161068 — Ahead 300
- K161368 — DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
- K161451 — BIB Stent Placement Catheter
- K161992 — Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
- K161994 — Aerin Medical Stylus
- K162188 — Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
- K162224 — ArtPix Mobile EZ2GO
- K162377 — PowerGlide Pro Midline Catheter
- K162384 — TrailBlazer Angled Support Catheter
- K151090 — CPL Insulin Pen Needle
- K160207 — ATLANTIS ISUS Implant Suprastructures
- K160413 — Sterling 5W Diode Laser
- K160816 — Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
- K161151 — Spinal fixation system
- K161439 — E-CUBE 11
- K161591 — QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
- K161746 — ARIX Hand System
- K161843 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
- K161879 — Solitaire Platinum Revascularization Device
- K162016 — Affinity NT Oxygenator with Cortiva BioActive Surface
- K162112 — CAAS MRV
- K162264 — Cascadia Interbody System
- K162338 — Full Automatic (NIBP) Blood Pressure Monitor
- K162339 — Scenium
- K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
- K162359 — Surefire Guiding Catheter
- K162411 — da Vinci Xi 12 8 mm Reducer
- K153505 — F&P Eson 2 Nasal Mask
- K160919 — Hansen Medical Magellan Robotic Catheter 9Fr
- K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
- K161344 — GentleCath Glide Intermittent Catheter
- K161455 — Catalys Precision Laser System
- K161717 — Personal Kinetigraph (PKG) System
- K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
- K161792 — PINPOINT Endoscopic Fluorescence Imaging System
- K161887 — Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
- K162306 — SomnoDent ALPHA
- K160862 — AirStrip RPM
- K161262 — Super Distal Access (SDA)
- K161625 — PixelShine
- K162497 — 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
- K161940 — Guidewire 0.6 Single Use
- K161112 — KARL STORZ Flexible Video-Neuro-Endoscope System
- DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation System
- K153654 — Sentry WEB SmartInterp
- K153733 — VORTRAN Manometer
- K160262 — n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,
- K160728 — NutraStim Hair Laser Helmet
- K160735 — CATSmart
- K160964 — Neodent Implant System - Titanium Base for CEREC
- K161162 — Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
- K161489 — Syntorr K-wire and Pin System
Data sourced from openFDA. This site is unofficial and independent of the FDA.