FDA 510(k) clearances — page 227
clearances on record, most recent first.
Clearances — page 227
22,601–22,700 of 175,699- 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
- K181419 — FLIX-EMS
- K190069 — SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
- K190297 — Celerity HP Incubator
- K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
- K190670 — ORTHOLOC 2 Lapidus with Rotation System
- K190848 — JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
- K190974 — D'Vill Introducer
- K190985 — BAROnova Insufflation System, BAROnova Accessory Kit
- K183109 — ControlRad Trace Model 8
- K190170 — MVP Cervical Plate System
- K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack
- K190604 — PIVO
- K190764 — SurgicalAR
- K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools
- K182180 — SPEAC System
- K181545 — Hysteroscope System
- K182612 — Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
- K182959 — Wallace Dual Lumen Oocyte Recovery System
- K183319 — Triangle System
- K183583 — Vanguard Complete Knee System
- K190027 — SteriStay
- K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
- K190275 — GenePOC Carba
- K190854 — Therm-X
- K190989 — 6400 Ultrasound System (MyLabX6, MyLabX7)
- K190995 — ExactVu High Resolution Micro-Ultrasound System
- K191046 — L10 LED Light Source with AIM, L11 LED Light Source with AIM
- K181491 — Delta Dual Mobility System
- K181894 — TOF-Cuff monitor
- K181933 — DePuy Synthes Sterilization Container System
- K182617 — ATEC IOM Accessory Instruments
- K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
- K183310 — Encore System
- K190218 — Unscented Menstrual Tampon
- K190393 — Wingman 14C Crossing Catheter
- K190666 — CYGNUS Anterior Cervical Plate System
- K190699 — Rowheels Revolution 1.0
- K190917 — V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
- K190948 — Magic Clear Aligners
- K182238 — Reprocessed ViewFlex Xtra ICE Catheter
- K182428 — GlucoLeader Enhance Blood Glucose Monitoring System
- K183126 — Electrosurgical accessory
- K183443 — SomnoDent Avant
Data sourced from openFDA. This site is unofficial and independent of the FDA.