FDA 510(k) clearances — page 318
clearances on record, most recent first.
Clearances — page 318
31,701–31,800 of 176,542- K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
- K161581 — Arthrex Synergy RF System
- K161876 — Tritium® Sternal Cable Plate System
- K161915 — Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
- K162228 — TorqVue Low Profile Delivery Catheter
- K142846 — BBX1, BBX2, BBX1MO, BBX1MC
- K153302 — coflex-IF
- K153387 — Luna CPAP and Auto CPAP System
- K153609 — RTS Flexible 1 MPJ Implant w/Grommets
- K160493 — Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
- K160958 — Battalion Universal Spacer System
- K161129 — PILLAR SA PTC
- K161166 — StageOne Select Cement Spacer Molds for Temporary Hip Replacement
- K161406 — Navident
- K161535 — SeaSpine® NewPort Spinal System
- K161866 — BioFlo Midline Catheter
- K161895 — 2MP Color LCD Monitor CCL214 (CL21214)
- K161966 — PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
- K162288 — SonoSite iViz Ultrasound System
- K162337 — Symbia 6.5
- K153207 — Additive Orthopaedics Bone Wedge System
- K153542 — Pelican Sling Retractor
- K153580 — Central Monitoring System
- K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
- K160575 — CareSens Pen Needle, Softip Pen Needle
- K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
- K160783 — Procellera
- K161165 — Next Science Irrigation Solution
- K161347 — Signia sterilization tray
- K161744 — Symmetry Sharp Kerrison Rongeur
- K161758 — Weck Auto Endo10 Automatic Endoscopic Clip Applier
- K162222 — GENflex2 Total Knee System
- K151455 — 3Shape Abutment Designer Software
- K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT
- K153046 — HAMILTON-MR1
- K160159 — Active-X Total Knee System
- K160269 — Surgical Face Masks (Ear loops and Tie-on)
- K160709 — HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves
- K161459 — Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
- K161478 — Xenco Medical Posterior Cervical System
- K161485 — Nanovis Intervertebral Body Fusion System and Forticore(R)
- K161585 — Mano and Mano Personal Lubricant
- K161600 — Resection Electrodes
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.