FDA 510(k) clearances — page 299
clearances on record, most recent first.
Clearances — page 299
29,801–29,900 of 176,542- K170616 — van Andel Dilatation Catheter
- K170882 — ABL90 FLEX, ABL90 FLEX PLUS
- K170926 — BrainPulse 1100
- K170945 — Biodesign Staple Line Reinforcement
- K170951 — CardioCel 3D
- K170952 — syngo.CT View&GO
- K171045 — Exactech® Truliant Line Extensions
- K160730 — Instrument kits
- K161450 — HAMILTON-C3
- K162142 — Accessory Irrigation Adapter
- K162334 — U.S. Laser Worx Patriot 1 family of lasers
- K162385 — RAPIDEC CARBA NP
- K170211 — Insight Dental System
- K170220 — OneQ-SL s-Clean Implant System
- K170905 — Star Tissue Marker
- K170930 — RSM 2430C
- K170949 — RadiForce MX315W
- K162271 — Pro-Lock CT Safety Infusion Set
- K162732 — Exactech® Alteon® HA Femoral Stem
- K163149 — VisualEyes
- K163332 — Apex Revision Knee System
- K170069 — AmCAD-UV
- K170300 — Restrata Wound Matrix
- K170572 — Summit Spine Yellowstone Lumbar Interbody Fusion System
- K170592 — NuVasive BASE Interfixated Titanium System
- K170889 — HV Screw System
- K170938 — CalSet IGF-1
- K170942 — The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K170964 — Zenius Spinal System
- K160670 — ET US SS Prosthetic system
- K162237 — XO1 Knee Balancing System
- K162661 — SavDenTM MTA Root Canal Filling Materials
- K162799 — Cliniview
- K163507 — Triton Sponge System
- K163675 — Processor VP-7000, Light Source BL-7000
- K170132 — MyoCycle Home, MyoCycle Pro
- K170260 — BC-001+ Acne Purifier
- K170511 — NeoFuse HA Enhanced PLIF/TLIF
- K170936 — Cutera enlighten III Laser System
- DEN160030 — Oculeve Intranasal Tear Neurostimulator Device
- K160499 — Apnea Risk Evaluation System (ARES), Model 620
- K162067 — VX130 Ophthalmic Diagnostic Device
- K162104 — C-Flex Ureteral Stent Set
- K162154 — Pantheon Medical Balanced Plating System
- K162441 — PowerPICC Provena Catheters with SOLO Valve Technology
- K162748 — MindMotionPRO
- K163650 — ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
- K170012 — Foot and Hand Motion
- K170536 — ECG Disposable Lead Wire
- K170858 — FDR AQRO (DR-XD 1000)
- K170887 — EVOS Small Fragment Plating System
- K160179 — VivaChek Ino Blood Glucose Monitoring System
- K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System
- K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)
- K162294 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K162655 — StealthConnect Remote Viewing, Planning and Collaboration System
- K162930 — Aero Chrome* Select Breathable Performance Surgical Gowns
- K163088 — TSIII BA Fixture
- K163255 — CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor
- K163516 — Braun No Touch + Forehead NTF3000 Thermometer
- K163537 — Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
- K163645 — DERMABOND PRINEO Skin Closure System
- K170221 — syngo.CT Cardiac Planning
- K170358 — joimax Endovapor 2
- K170537 — Nexxis OR, Nexxis
- K170716 — PercuNav Image Fusion and Interventional Navigation
- K170721 — Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
- K170865 — EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
- K170869 — LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
- K170953 — Tomcat Cervical Spinal System
- K152830 — K3
- K161910 — Cardinal Health Sterilization Wrap
- K162017 — Ross Ru Wound Dressing Gel
- K162151 — PENTAX Medical ENT Video Imaging System
- K162236 — Ax Stand-Alone ALIF System
- K162354 — Sniper Staple System
- K162607 — BeneVision Central Monitoring System
- K162722 — HyperSense
- K162901 — Penumbra 3D Revascularization Device
- K163160 — Sterile Single-use Infusion Set
- K163235 — HEM-9210T
- K163415 — SlimShape System
- K163677 — Ortho System
- K163690 — DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
- K163708 — QiF Blood and Fluid Warmer
- K160502 — TEG 6s Hemostasis System
- K160680 — VisioFocus Mini, VisioFocus Smart
- K161884 — Ortho System
- K163383 — GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
- K170052 — Stellaris Elite vision enhancement system
- K170215 — LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
- K160967 — Finapres Nova Noninvasive Hemodynamic Monitor
- K162087 — NovoGro
- K162296 — OmniPod Insulin Management System
- K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- K163387 — PICO Single Use Negative Pressure Wound Therapy System
- K163523 — ECHELON CIRCULAR Powered Stapler
- K170120 — EndoRotor
- K170247 — Lacriflow CL
- K170406 — Plato MICROCATH 27B Microcatheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.