FDA 510(k) clearances — page 314
clearances on record, most recent first.
Clearances — page 314
31,301–31,400 of 175,699- K152905 — ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
- K153268 — NR Line Implant System
- K153328 — SUNCO Mechanical Wheelchair, model SKW-9003
- K153498 — Operio
- K160333 — Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
- K160984 — MultiScan G-Arm System
- K161052 — OsteoFab Patient Specific Facial Device
- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- K161138 — St. Louis Band
- K161227 — VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
- K153557 — ABPM 7100, Hypertension Management Software
- K160804 — INTRAFIX(TM) Advance Tibial Fastener System
- K160907 — DePuy Actis DuoFix Hip Prosthesis
- K161155 — Origin Coxa Vara Hip Stem
- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
- K161443 — Ekso (version 1.1) and Ekso GT (version 1.2)
- K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer
- K160504 — RI Witness Embryology Heated Plate
- DEN150004 — EPIC ClearView System
- K151978 — EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
- K152294 — FDR Visionary Suite
- K153097 — Belvedere Lateral Plating System
- K153621 — Juliet® Ti
- K160016 — Steth IO
- K160271 — N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
- K160308 — Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
- K160425 — CAD/CAMouflage Milling Bock
- K160631 — Keos Lumbar IBFD
- K160704 — myPatch-s
- K161223 — TransContinental® M Spacers and InterContinental® Plate-Spacers
- K161265 — NuVasive® VersaTie System
- K161407 — Ascential IBD PEEKc Spacer
- K161659 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
- K161694 — Threshold Pedicular Fixation System
- K161920 — Comfort Cover
- K151790 — PMT Platinum Depthalon Depth Electrode
- K153087 — IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
- K153230 — ShefaBone SCPC Resorbable Bone Graft
- K153422 — Panpac Disposable Pessary Fitting Set
- K160031 — Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
- K160102 — Amber Mill Series and Amber Press Series
- K160518 — LEONI ORION System
- K160613 — Soberlink Cellular Device and Sober Sky Web Portal
- K160846 — AmplifEYE
- K160848 — Wingman 18 Crossing Catheter
- K160906 — Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
- K160988 — Biopor, AOC Porous Polyethylene, Cerepor
- K161072 — Powder Free Grey Vinyl Examination Gloves
- K152764 — EXACTECH GPS
- K152952 — E-Cath
- K160431 — ActiveCare Home
- K160482 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K160551 — VALO Grand
- K160744 — LOOK PTFE Suture
- K160803 — Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
- K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
- K160977 — PolyDev Soft Contact Lenses
- K161163 — PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
- K161419 — Multi Modality Viewer
- K161525 — TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
- K152803 — SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
- K153325 — Gradia Plus
- K153568 — InMode Plus System
- K160077 — RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
- K160123 — Apinator
- K160448 — ARTLINE
- K161055 — Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
- K161175 — Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
- K161337 — CryoDose H or Similar
- K161640 — Penumbra System ACE 68 Reperfusion Catheter
- K161726 — E-Pack Procedure Kit
- K152166 — JSM Insulin Pen Needle
- K152511 — Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
- K152628 — Pulse H20h!
- K152671 — Pulse Aloe-ahh
- K153055 — ACE Electrosurgical Resection and Vaporization Electrodes Series
- K153105 — MLX - Medial Lateral Expandable Lumbar Interbody System
- K153786 — PROW FUSION-V
- K160758 — PeriCoach OTC
- K160875 — Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
- K161149 — PASS OCT Spinal System
- K161271 — da Vinci Xi Surgical System
- K161685 — syngo®.via protoNeo (Version VA10A)
- K153272 — INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
- K151870 — BD U-500 INSULIN SYRINGE
- K152461 — The Time Machine Series Lasers
- K152622 — Alta ACDF System
- K152703 — PlasmaBlade TnA Tonsil and Adenoid Dissection Device
- K152920 — Savannah-T® Pedicle Screw System
- K153048 — AcceleDent Aura
- K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
- K153357 — i-STAT Alinity System with i-STAT Sodium test
- K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
- K160715 — AccuLIF TL and PL Cage
- K160896 — ULTRASHAPE POWER SYSTEM
- K160978 — LITe BIO Delivery System
- K161089 — sensiLight Mini
- K161192 — Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
- K161238 — S-scan
Data sourced from openFDA. This site is unofficial and independent of the FDA.