FDA 510(k) clearances — page 301
clearances on record, most recent first.
Clearances — page 301
30,001–30,100 of 176,542- K163076 — Segment CMR
- K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
- K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
- K163435 — Entellus Medical Reinforced Anesthesia Needle
- K163509 — XprESS ENT Dilation System
- K163711 — IQon Spectral CT
- K170377 — TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
- K170456 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K170668 — HeartSpan Steerable Sheath Introducer
- K170677 — Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
- K170719 — Anzai Respiratory Gating System
- K170837 — Nio Color 3MP (MDNC-3421)
- K162206 — Zavation IBF
- K162544 — OsteoMed PINNACLE Driver
- K162782 — iHelmet Hair Growth System
- K163221 — Mazor X
- K163303 — OsteoMed ExtremiFix Mid and Large Screw System
- K163458 — Zenysis Short-Term Dialysis Catheter
- K163459 — Nihon Kohden Vital Sign Telemeter
- K163613 — Bluephase Style 20i
- K170040 — BePOD Cannulated Arthrodesis Screws
- K170315 — Acuson SC2000 Diagnostic Ultrasound System
- K170347 — CD HORIZON Fenestrated Screw Set
- K170411 — ER-REBOA Catheter
- K170560 — SAGE Vitrification Kit and SAGE Vitrification Warming Kit
- K170678 — Beta-CrossLaps CalCheck 5
- K170731 — System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
- K170781 — MX50N(MX50YQS)
- K161353 — ESTELITE BULK FILL Flow
- K162241 — TITAN 3-D Wedge System
- K163426 — ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
- K170075 — AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
- K161257 — MultiPulse HoPLUS
- K161530 — Bluetooth blood pressure monitor
- K161635 — AMIStem-H Proximal Coating
- K162167 — Caphosol Artifical Saliva Tablets
- K162186 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
- K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software
- K162413 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K162530 — Multichem IA Plus
- K162559 — Move Forward 3D Motion Simulation Service
- K162626 — THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
- K162627 — EnsoSleep
- K162820 — AC3 Series IABP System
- K162873 — MEP Monitor
- K163096 — GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
- K163350 — Multibase Abutments EV and ATLANTIS Suprastructures
- K163649 — SureSigns VS3; SureSigns VS4
- K170098 — ICONIX TT All Suture Anchor
- K170243 — LOSPA IS TLIF & DLIF Cages
- K170284 — Great Basin Bordetella Direct Test
- K170449 — Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
- K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
- K170628 — BioMonitor 2-AF, BioMonitor 2-S
- K170783 — CX50N(CX50YQS)
- K162471 — Hach CM130 Chlorine Monitoring System
- K162995 — Ibis® Pedicle Screw System
- K170009 — Esophageal Cooling Device
- K170077 — LUOFUCON Silicone Ag Foam Dressing with Border
- K170271 — NuVasive(r) Monolith Corpectomy System
- K170310 — Alians Clavicle range
- K170327 — Parcus SLiK Anchors
- K170635 — Chameleon PTA Balloon Catheter
- K170743 — AngioDynamics Total Abscession Biliary Drainage Catheter
- K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
- K161929 — Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
- K162124 — Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
- K162693 — VertebraLINK Fusion Platform
- K162999 — V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
- K163052 — Brevera Biopsy System with Corlumina Imaging Technology
- K163529 — ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
- K163700 — Bodycad Unicompartmental Knee System
- K170161 — New Deantronics E Green Electrosurgical Monopolar Pencils
- K170654 — USS System
- K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
- K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
- K162405 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White) +1 more
- K162789 — Foresight Intracardiac Echocardiology (ICE) System
- K163565 — MR8 Drill System
- K170476 — Nio Color 5.8MP (MDNC-6121)
- K170493 — HS50 / HS60 Diagnostic Ultrasound System
- DEN160028 — ipsogen JAK2 RGQ PCR Kit
- K161667 — Sapphire Infusion Pump
- K161731 — Cleveland Multiport Ventricular Catheter Set
- K161812 — Freedom Syringe
- K163248 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K162784 — Silk'n HST
- K160581 — K3PRO Konus Additional Abutments and Implants
- K161680 — MEDICON Spinal Spreading Systems
- K161835 — iovera system
- K162023 — CardioDay V2.5
- K162028 — PREMIUM - SHELTA Prosthetic Components
- K162235 — LUVENA VAGINAL MOISTURIZER & LUBRICANT
- K162342 — Stellaris Elite Vision Enhancement System
- K162503 — Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
- K162556 — LIGHTFUSION LED SYSTEM
- K162615 — Mould Applicator Set
- K162701 — VERIFY Assert Self-Contained Biological Indicator
- K162850 — GuideMia Ortho+
- K162967 — nuance UNIVERSAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.