FDA 510(k) clearances — page 212
clearances on record, most recent first.
Clearances — page 212
21,101–21,200 of 176,479- K192096 — Omnia Medical Trauma Screws
- K192305 — Colibri Endoscopy System
- K192619 — Pitkar Locked Plating System
- K192683 — Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
- K192804 — CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
- K192876 — INTELLIO Tablet Application
- K193242 — Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
- K193268 — APrioCore Plus
- K193274 — Rodo Abutment System
- K193313 — Elecsys Anti-TSHR
- K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
- K200247 — Fusion Quattro Extraction Balloon
- K191463 — DePuy Synthes Hammertoe Continuous Compression Implant
- K192192 — VSP System
- K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
- K200189 — Luna Dental Implant System- Healing Abutment
- K200197 — ARK Fentanyl II Assay
- DEN190020 — iTind System
- K191389 — Allcem Veneer APS
- K191402 — Heater-Cooler System 3T
- K192253 — SonicEye Dual-Array Ultrasound System
- K192898 — PneumoLiner
- K193414 — Trigon HA Stand-Alone Wedge Fixation System
- K200016 — uCT 530, uCT 550
- K200178 — Ez3D-i /E3
- K200234 — Surgical laser fibers
- K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators
- K191474 — NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
- K191858 — Pylant Monitor
- K192756 — Aquadex FlexFlow System 2.0
- K192855 — DELTA XTEND(TM) Reverse Shoulder System
- K193180 — Alliance Augmented Glenoid
- K193412 — NEXXT MATRIXX System
- K193451 — Titanium Interference Screws
- K200214 — 3D Predict
- K193308 — T2 Alpha Tibia Nailing System, IMN Screws System
- DEN190023 — AmplideX Fragile X Dx & Carrier Screen Kit
- K190363 — Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
- K190641 — AR_N SLA Type Implant System
- K191030 — Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
- K191313 — Unity Subcutaneous Infusion System for Remodulin
- K191407 — Novalung System
- K191536 — Biatain Silicone Ag
- K191646 — Beamscan MR
- K191697 — Cardiac Monitor 1500
- K191728 — ULTepap Expiratory Positive Airway Pressure (EPAP) Device
- K191740 — DORO LUCENT® iXI and iMRI Headrest System
- K191894 — Upper Arm Blood Pressure Monitor
- K192072 — Tina-quant C-Reactive Protein IV
- K192263 — UCLA CCM Abutment
- K192491 — Coolief Radiofrequency Generator (CRG) System
- K192600 — Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
- K192691 — PatCom Single-Use Introducer
- K192799 — Glenoid Baseplate with Screw
- K192832 — Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
- K192851 — OASIS MRI System
- K193118 — TGS Guidewire and updated Scopis Software
- K200148 — LightForce Orthodontic System (LFO System)
- K200161 — 3MP Monochrome Digital Mammography LCD Monitor MS-S300
- K200184 — SmoothSkin Pure
- K190406 — SDS2.2 dental implant
- K190806 — Flowart
- K191719 — X-MIND Trium
- K192545 — Potenza
- K192617 — Gemini 810+980 Soft Tissue Laser
- K192624 — ApneaTrak
- K192918 — Video Laparoscope, Video Processor, Light Source
- K192922 — Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
- K193015 — HydroPICC (PICC-142)
- K193098 — Exactech® Equinoxe® Reverse Shoulder Glenospheres
- K193255 — Largo PEEK Interbody System
- K193303 — Tinnitus Sound Generator Module
- K193533 — WIN Flexible Nail System
- K193596 — Wingman 14, Wingman 14C, Wingman 18, Wingman 35
- K192000 — D R Burton OxyPAP
- K192460 — Sentinel Cerebral Protection System
- K192973 — densitas densityai
- K193012 — speX Support Catheter
- K193209 — Wego-Stainless Steel
- K200228 — ClearCam System
- K190487 — InPen Dose Calculator
- K191514 — CareStart Flu A&B Plus
- K192381 — DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
- K192674 — Mixing and Delivery System
- K192677 — Safety Insulin Pen Needle
- K192894 — Vita Flex CR System with LLI
- K193203 — MOJAVE Expandable Interbody System
- K200132 — Ashvins
- K200179 — Collaboration Live
- K193466 — Swan-Ganz Catheters
- K193554 — APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
- K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
- K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191364 — T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
- K191737 — The Graft Bone Substitute
- K191785 — Orion LifeSpan MEG
- K192120 — Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm
- K192143 — Maximus System
- K192277 — CardIQ Flow
- K192372 — ASCEND Image Viewer
Data sourced from openFDA. This site is unofficial and independent of the FDA.