FDA 510(k) clearances — page 296
clearances on record, most recent first.
Clearances — page 296
29,501–29,600 of 176,542- K163356 — Pulse* Spray Infusion System, Uni*Fuse Infusion System
- K163505 — ARIETTA PRECISION
- K163702 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
- K170521 — TRINITY/3D PROSTATE SUITE
- K170604 — FilmArray Respiratory Panel 2 (RP2)
- K170695 — VenaCure EVLT NeverTouch Direct Introducer Sheath
- K170899 — 27HJ713S
- K170954 — Portable ECG Monitor
- K171306 — gammaCore-S
- K171314 — QLAB Advanced Quantification Software
- K162448 — White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
- K162526 — Creatine Kinase-MB
- K162603 — Masimo O3 Regional Oximeter System
- K163065 — T3 Software
- K163140 — SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
- K163349 — MIS V3 Conical Connection Dental Implant System
- K170093 — AcceleDent Optima
- K170133 — FFR V2.5
- K170178 — Ultravision Visual Field Clearing System
- K170216 — Flexitouch System
- K170659 — IQ Technologies
- K170692 — Respire Pink Series with DentiTrac
- K170839 — RAPID Web
- K171059 — Nova StatSensor Creatinine Hospital Meter System
- K171217 — DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
- K171229 — DELL UP3017 with QUBYX PerfectLum bundle
- K171230 — My Dose Coach
- K171234 — Mistral-Air Warming Unit
- K171294 — da Vinci X Surgical System
- K171296 — SutureTape
- K170242 — MultiGen 2 RF Generator System
- K170259 — TruAbutment DS
- K170486 — CATHTONG II PICC Catheter
- K170557 — GenePOC GBS LB
- K170558 — revogene
- K170597 — PicoWay Laser System
- K170611 — SETx Pedicle Screw System
- K170892 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
- K170944 — LCD Monitor (MD310C, MD310G, MD210G)
- K171170 — M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
- K171238 — KARL STORZ ICG Imaging System
- K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
- K162409 — Gems Vitrification Set, Gems Warming Set
- K162433 — GCE Zen-O Portable Oxygen Concentrator
- K162463 — Matrix Data Management System
- K163071 — vascuCAP
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163196 — ACTION II Laser System
- K163197 — Cook Holmium Laser Fiber
- K163244 — truFreeze System
- K163257 — VitreOx Anti-fog Solution
- K163618 — INDIGO Aspiration System
- K170172 — UNiD Spine Analyzer
- K170287 — Dental Implants OKTAGON Bone Level Tapered Design
- K170290 — Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
- K170306 — FIBERGRAFT BG Putty Bone Graft Substitute
- K170349 — RA-308 Excimer Laser System, Excimer Laser Catheter
- K170514 — Central Monitoring System
- K170603 — Tao Brush I.U.M.C. Endometrial Sampler
- K170779 — Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
- K170891 — Mako Partial Knee Application
- K171194 — AS-10, CXDI-401RF
- K161833 — LATEX EXAMINATION GLOVE POWDER FREE
- K162598 — HAPI Seal
- K163090 — Plasma Edge System
- K163430 — Prontosan Wound Gel
- K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
- K163673 — Fortilink-C with TETRAfuse 3D Technology
- K170489 — Skylit Phototherapy System
- K161689 — OSSTEM Implant System - Abutment
- K163394 — Hybrid3D
- K163553 — Powder Free Nitrile Patient Examination Gloves, Blue
- K170021 — SMV Scientific Cannulated Screws
- K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
- K170282 — Smith & Nephew VISIONAIRE Adaptive Guides
- K170586 — Strep B Carrot Broth One-Step
- K170989 — Dymaxeon Spine System
- K171348 — Pinpoint GT Needle Guide Kits
- K170446 — LT-300 SD Digital Video Colposcope
- K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
- K160677 — MICRORUPTOR 6
- K161807 — BEAMSCAN
- K161813 — Frova Intubating Introducer
- K162212 — DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
- K162542 — OsteoMed PINNACLE Driver
- K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
- K163261 — AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
- K163564 — SLIT LAMP SL-2000
- K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece
- K163644 — Nihon Kohden QP-160AK EEG Trend Program
- K170018 — StealthStationTM S8 ENT Software
- K170303 — E5 Series Digital Color Doppler Ultrasound System
- K170322 — Catalys Precision Laser System
- K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- K170752 — OEC Elite
- K170874 — Eko Model E5 System (EME5), Eko DUO
- K170908 — PK AIM
- K171152 — Stryker Universal Neuro III System AXS Screw
- DEN170019 — Vitamin D 200M Assay for the Topaz System
- K160509 — Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
Data sourced from openFDA. This site is unofficial and independent of the FDA.