FDA 510(k) clearances — page 310
clearances on record, most recent first.
Clearances — page 310
30,901–31,000 of 175,699- K161765 — CG+ Arrow JACC
- K162221 — ACUSON SC2000 Diagnostic Ultrasound System
- K162243 — ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
- K162267 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
- K161756 — SyncVision System
- K161465 — CardioConfirm
- DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- K152981 — JET SET 4 DENTURE REPAIR RESIN
- K153705 — PROcedure Rehearsal Studio
- K153707 — Nihon Kohden Vital Sign Telemeter
- K160066 — Pro-Link® Stand-Alone Cervical Spacer System
- K160423 — Perineologic Access Needle
- K160582 — WiCap
- K160593 — Indy OTW Vascular Retriever
- K160698 — LigaPASS
- K161168 — MyLabSix Ultrasound System
- K161317 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K161524 — Tangis Anterior Cervical Plate
- K161573 — FilmArray RP EZ Control Panel M265
- K161602 — Arctic Sun Temperature Management System
- K161751 — MAGEC® Spinal Bracing and Distraction System
- K162141 — Restore PACS
- K162184 — Edwards eSheath Introducer Set
- K152405 — IBL 5000 Tanning Booth
- K153469 — Cathtong I PICC Catheter
- K153599 — Concert Medical Hands-Free Syringe (HFS)
- K160274 — Hi bebe plus
- K160429 — BC-5390 Auto Hematology Analyzer
- K160531 — Noiselezz
- K160606 — BC-5D Hematology Control
- K161063 — EzRay Air (Model VEX-P300)
- K161239 — MTA2.2 MATERIAL
- K161312 — Sysmex Automated Blood Coagulation Analyzer CS-2100i
- K161320 — EMG Pink Nitrile Examination Glove Powder Free
- K161392 — Elation Pulmonary Balloon Dilation
- K161565 — DUO
- K161567 — SIGNA Voyager
- K161656 — Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
- K161707 — Madsen Zodiac
- K161922 — XP202
- K161942 — PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
- K161963 — Monoject Enteral Syringe with ENFit Connector
- K162178 — CareView 1500P X-ray Flat Panel Detectors
- K151047 — MTA Repair HP
- K153649 — Exactech® Novation® Element Press-fit Femoral Stem
- K160944 — ACCU-CHEK Guide Blood Glucose Monitoring System
- K161367 — HydroCoil Embolic System (HES)
- K161397 — MAGiC
- K161452 — MicroPlex Coil System (MCS) - HyperSoft 3D
- K161544 — Trojan Chain Reaction Personal Lubricant
- K161588 — Vscan Extend
- K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils
- K162129 — RENASYS-G Gauze Dressing Kits with Soft Port
- K162152 — Erbes CO2 Tubing/Cap Sets
- K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- K160149 — Miret Grasper, Alligator, Miret Grasper, Maryland
- K160723 — OnSight 3D Extremity System
- K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
- K162189 — ANAX 5.5 Spinal System
- K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
- K153706 — Insulin Pen Needle
- K160597 — INDEPENDENCE MIS Spacers
- K160626 — ATLANTIS Abutment for HIOSSEN ET implant
- K161108 — Arthrex VaultLock Glenoid
- K161211 — Digital Thermometer
- K161311 — USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
- K161532 — Philips Avent Comfort Single/Twin Electric Breast Pump
- K161570 — Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
- K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
- K161777 — BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
- K162119 — UreTron PF Series Probe
- K150830 — CompleClear Plastic Orthodontic Bracket and Wire Appliance
- K152197 — Skypro, SP01 Mask
- K152642 — LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
- K153509 — GPS Angled Abutment
- K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
- K160106 — LUNA DENTAL IMPLANT SYSTEM
- K160253 — Vitalograph Model 6300 micro
- K160600 — Freedom Spinal Cord Stimulator System
- K160615 — ORTHODONTIC CERAMIC BRACKETS 1.1
- K160797 — FMX314 Surgical Platform
- K160943 — Bite Away
- K161030 — ATLANTIS Abutment for CONELOG implant
- K161124 — EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
- K161503 — ORION
- K161545 — Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
- K162094 — RS80A Diagnostic Ultrasound System
- K152659 — V10
- K153494 — HQS Introducer (Model 2064-HQS)
- K153560 — Optilite Low Level Albumin Kit
- K153731 — LifeFlow Rapid Infusion Device (LifeFlow Device)
- K160379 — Exufiber Ag+
- K160455 — AneurysmFlow
- K160650 — LIAISON HAV IgM, LIAISON Control HAV IgM
- K160764 — AirLife Autofill Humidification Chamber
- K161126 — ASAHI Corsair Pro
- K161189 — Integra TITAN Reverse Shoulder System
- K161195 — Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
- K161230 — NuVasive Lumbar Interbody Implants
- K161355 — invendoscopy E200 System
Data sourced from openFDA. This site is unofficial and independent of the FDA.