FDA 510(k) clearances — page 323
clearances on record, most recent first.
Clearances — page 323
32,201–32,300 of 176,542- 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
- K161333 — TightRail Sub-C Rotating Dilator Sheath
- K152564 — Gemini Sterilization Wrap
- K153234 — AirLife Adult Heated Wire Circuit
- K153240 — Styrker OrthoMap Express Knee System
- K160088 — Cydar EV
- K160722 — CorticaLINK Spinal Fusion Platform
- K161305 — Habib EUS RFA
- K153017 — Voyant Fine Fusion
- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- K153231 — G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
- K160433 — V-PRO® 1 Plus and V-PRO® maX Low Temperature
- K160439 — SunTech CT40 Spot-check Vital Signs Device
- K160557 — Full Automatic (NIBP) Blood Pressure Monitor
- K160569 — NeuGuide
- K160830 — Integra External Fixation System
- K160956 — LD-Oxi system
- K160996 — Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
- K160997 — GC85A
- K161012 — Easy-Load Lens Delivery System
- K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K161296 — Cool Renewal
- K161314 — FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
- K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
- K161395 — SPEC Model M13
- K161553 — BD SafeAssist
- K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set
- K153399 — LightStim Professional LED Bed
- K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
- K160607 — PicoWay Laser System
- K160947 — LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
- K153674 — Sorbact Foam Gentle Border, Sorbact Superabsorbent
- K160604 — Cure Anterior Cervical Plate (ACP) System
- K160904 — Expedium Spine System, VIPER and VIPER 2 Systems
- K161302 — PC ECG
- K161523 — INDIGO Aspiration System
- K161531 — IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2 +4 more
- K153136 — Initial LiSi Press
- K153177 — Admira Fusion Flow
- K153372 — Repagyn vaginal suppositories
- K153645 — VITA ENAMIC Implant Solutions (IS)
- K153689 — STERIZONE Sterilizer
- K153740 — RTHawk, HeartVista Cardiac Package
- K153749 — 3 Series Phototherapy Unit
- K160235 — ViaValve Safety I.V. Catheter
- K160441 — Identic and KromaFaze Alginate Dental Impression Materials
- K160644 — Lelo Hex Natural Rubber Latex Condom
- K161247 — Relizorb
- K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- K161522 — LIAISON EBV IgM Serum Control Set
- K161526 — LIAISON CMV IgM Serum Control Set
- K161539 — Arthrosurface Bone Screws
- K161556 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
- K151986 — ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
- K152501 — Spinal Jaxx Interbody Fusion Device
- K152737 — Lite Touch
- K153273 — MySpine Pedicle Screw Placement Guides - LP
- K153360 — ADMIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.