FDA 510(k) clearances — page 235
clearances on record, most recent first.
Clearances — page 235
23,401–23,500 of 176,542- K190482 — IGNITE Bone Void Filler
- K190606 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
- K190686 — Optilite IgM CSF Kit
- K182515 — Surgical Face Mask
- K181157 — Conical Plus Implant System
- K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
- K182321 — MobileLink Acetabular Cup System
- K182575 — Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K183530 — TruDiagnosis System
- K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
- K190231 — InCore® Lapidus Sterile Kits
- K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
- K190378 — Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
- K190448 — LightLas Pattern Scanning System - TruScan Pro
- K190542 — Soliton Acoustic Wave Device
- K190603 — Tria Firm Ureteral Stent
- K190802 — Envision ultrasound pad and cover
- K191083 — COMPLETE CONTROL System Gen2
- DEN180032 — Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
- DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA
- K182362 — MaxCap Ped and MaxCap Neo
- K182390 — IMPEDE-FX Embolization Plug
- K182458 — Longterm NPWT Foam Dressing Kit
- K182937 — Upstream GoBack Crossing Catheter
- K183054 — SYNMESH System
- K183560 — Luna 3D GEN2 Interbody Fusion System
- K183639 — Mariner Outrigger Revision System
- K183654 — PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
- K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
- K190436 — KATANA Zirconia Block
- K190441 — Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
- K190452 — Aptima BV Assay
- K190469 — ERBEFLO 2 Disposable Tubing System
- K190515 — Aptima Combo 2 Assay (Panther System)
- K191091 — Rampart One Lumbar Interbody Fusion System
- K182350 — Dental Ceramic
- K182374 — LIAC S
- K183611 — Soniquence RF Generator and Soniquence Electrodes
- K183644 — Stealth-Midas MR8 System
- K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
- K190444 — HERA I10 Diagnostic Ultrasound System
- K190751 — Connector System
- K190769 — Bladder Scanner (Models: M2, M2-W, M1, M1-W)
- K190823 — Erbe ESU Model VIO 3 with Accessories
- K190902 — RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
- K191080 — Ambu aScope 4 RhinoLaryngo Slim
- K182342 — IntraLock Lapidus System
- K182576 — Solax Powered Wheelchair
- K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
- K182975 — MAKO 7
- K183242 — ET IV SA Dental Implants
- K183646 — Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure
- K190367 — Smith & Nephew Tablet Application
- DEN180059 — Nerivio Migra
- K182235 — OnSite Waste Sharps Container
- K183655 — VersaCross Transseptal Sheath
- K190134 — Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
- K190332 — Aperio AT2 DX System
- K190125 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- K183597 — QIAstat-Dx Respiratory Panel
- K173570 — SD Abutment
- K182252 — Cook Unimpregnated Central Venous Catheter
- K182302 — CardioGard Emboli Protection Cannula
- K182394 — WiZARD 310/320 Series CPAP Mask
- K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
- K183077 — Delta Xtend Reverse Shoulder System
- K183381 — Navigation Enabled Instruments
- K183417 — iRestore Professional 282
- K183505 — KY Banksy Moisture
- K183618 — Revolution Radial Head
- K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
- K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
- K191025 — DRX-Revolution Mobile X-ray System
- K191029 — Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
- K173895 — Tel-O-Graph
- K182251 — EVOLUTION NitrX Medial-Pivot Knee
- K182734 — Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
- K183534 — Fully Automatic Electronic Blood Pressure Monitor
- K190345 — VPC
- K190355 — Precision Casting Solutions Total Knee System
- K190372 — Aveta System
- K190472 — Aptima CV/TV Assay
- K191000 — Carnation Ambulatory Monitor
- K191023 — Dolphin/IQ, Dolphin/4D and Dolphin/MAX
- K191040 — syngo.via (Version VB40A)
- K191051 — ARGOS
- K182328 — VeriClear Digital Early Result Pregnancy Test
- K182408 — Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
- K182520 — Flexible Overtube
- K182532 — Liba3 System
- K182602 — SOFIA EX Intracranial Support Catheter
- K183277 — SpO2 Sensor
- K183292 — Topaz Mobile DR System
- K183648 — APAS Independence with Urine Analysis Module
- K183697 — Masimo Rad-97 and Accessories
- K190034 — REMY Medical Therapy Laser System
- K190405 — BACT/ALERT MP Reagent System
- K190493 — Recovery Pump, 737R (RPX)
- K190584 — CAYMAN LP Plate System
- K190639 — Endosee System
Data sourced from openFDA. This site is unofficial and independent of the FDA.