FDA 510(k) clearances — page 309
clearances on record, most recent first.
Clearances — page 309
30,801–30,900 of 175,699- K161568 — Bone Solutions Mixing and Delivery System
- K161804 — LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
- K161946 — DoseCHECK
- K162008 — JiveX
- K162079 — TRILLIUM Oval Head Coil 32
- K162475 — mi-eye 2, mi-eye 2 monitor
- K151962 — KBL Sunlamp Products (= Device Bundling name)
- K152023 — Luminesse Shaded Zirconia SZ
- K152946 — TEMPEDY
- K153665 — PROW FUSION-L
- K160255 — HBOTC Muscle and Nerve Stimulator
- K160529 — Pledgeted COR-SUTURE QUICK LOAD
- K160828 — Dentium Implantium & SuperLine Prosthetics
- K161067 — Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6
- K161294 — Compound W Wart Removal System Dual Power
- K161630 — Provicol QM Plus
- K162012 — CARESCAPE Central Station V2
- K162013 — Eusol-C
- K162047 — LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
- K162053 — PhotonBlade
- K162110 — CORGRIP NG/NI Tube Retention System
- K153311 — Flexitouch System
- K153660 — StealthStation System with Cranial Software
- K153676 — OSTEON III
- K153723 — ACTICOAT Surgical Dressing
- K160341 — Colposcope System
- K160784 — CAM Titanium Blanks
- K161081 — SeaSpine Shoreline ACS - Anterior Cervical Standalone System
- K161384 — Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
- K161658 — Anexa Wound Flush, Sterile Water & Sterile Normal Saline
- K161818 — GEM Premier 3000
- K162172 — EBit Series Diagnostic Ultrasound System
- K162177 — dS FootAnkle I6CH 1.5T Coil
- K162195 — TSolution One Cup1 Surgical System
- K162329 — CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
- K153130 — Initial LiSi Block
- K153771 — TXM Guiding Sheath
- K161263 — OptoMonitor II
- K161551 — TR-100
- K160221 — Implance Dental Implant System, Implance Dental Abutment System
- K160867 — Pavati Z40.2 Zirconia
- K161043 — Profound System
- K161888 — JULIET® LL Lateral Lumbar Cage
- K161519 — NeuroStar TMS Therapy System
- K151839 — AMC Health VitalCaregiving System
- K152879 — Sure-Fine Insulin Syringes
- K153636 — Liberator Powered Wheelchair with Solar Companion
- K153701 — ULYSS Multi View Sinuscope
- K160117 — AbClose - Port Site Closure Device
- K160554 — Enseal X1 Large Jaw Tissue Sealer
- K160754 — Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
- K160822 — S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
- K161004 — Self-retaining Retractor
- K161051 — All-Bond Universal w/BAC (not finalized)
- K161187 — EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
- K161201 — ClearRead CT
- K161356 — Matrix LS-40 CO2 Laser System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.