FDA 510(k) clearances — page 339
clearances on record, most recent first.
Clearances — page 339
33,801–33,900 of 175,770- K151095 — Circumplast Circumcision Device
- K151189 — Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
- K151302 — Clinpro Varnish
- K151392 — Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
- K151446 — Recovr Rehabilitation System
- K151518 — BRUSH&BOND PLUS
- K151684 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
- K151728 — CoStorSol plus G
- K151979 — STARband, STARlight
- K152161 — Thoratec CentriMag Return (Arterial) Cannula Kit
- K152190 — Thoratec CentriMag Drainage (Venous) Cannula Kit
- K152316 — iLab Ultrasound Imaging System
- K152335 — Export Advance Aspiration Catheter
- K152393 — Eclipse Treatment Planning System
- K143640 — KSEA CMOS Camera System (C-cam)
- K150765 — LDR Spine ROI-C Cervical Cage System
- K150958 — LifePearl Microshperes
- K150965 — LeForte System II
- K151071 — SmartLinx Vitals Plus Patient Monitoring System
- K151188 — BodyGuardian Remote Monitoring System
- K151471 — Radifocus Glidewire Endoscopic Wire
- K151522 — DEFENDO Bronchoscopy Suction Valve
- K151727 — Everest Spinal System
- K152031 — New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
- K152098 — ODALYS Pedicle Screw System
- K152131 — Reliance Spinal Screw System
- K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System
- K142530 — Partial Knee Application (PKA)
- K143051 — ArgenIS Titanium Abutments
- K143349 — Gynomunal
- K143450 — Ackermann Intervertebral Body Fusion Device
- K143557 — SupaScoota Motorized vehicle
- K150067 — OTSC Proctology
- K150382 — Radio Therapy Treatment Chair
- K150594 — Biodesign Otologic Repair Graft
- K150720 — XP3000
- K150899 — Straumann CARES Titanium Alloy (TAN) Abutment
- K151400 — Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
- K151887 — syngo VSim
- K152030 — Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
- K152032 — ELUMI 810 + 980 Soft Tissue Laser
- K152052 — Ultrasound Scanner System bk2300
- K152142 — RECON system - MPJ-Plates
- K152346 — MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
- K141177 — VITALA PORCINE DERIVED COLLAGEN MEMBRANE
- K150111 — Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
- K151245 — Rhythm View Workstation (non-streaming, steaming option)
- K151554 — Occlusion Perfusion Catheter
- K151630 — G.o.c.c.l.e.s.
- K151655 — CO2RE System
- K142657 — XEROSTOM SALIVA SUBSTITUTE GEL
- K143177 — KleenGel Dispenser
- K143644 — Premium Surgiclip¿; Endo Clip¿; AcuClip¿
- K151144 — SuPro 100
- K151208 — Powder Free Nitrile Examination Glove
- K151645 — MAMMOMAT Fusion
- K152309 — LOGIQ E9, LOGIQ E9 XDClear 2.0
- K143359 — CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
- K143413 — J+PRAS YOUNG'S Thread
- K150381 — AQUA CLEANSE
- K150619 — CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
- K151324 — Straumann Variobase for CEREC
- K151368 — Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
- K151560 — QuickPlan
- K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator
- K151990 — Tissue Removal System
- K152018 — Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
- K152303 — CT Sim Laser System
- K150112 — HS AMICA DEVICES FAMILY
- K150840 — Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
- K150959 — Sutter Bipolar Forceps-Calvian
- K151112 — Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
- K151322 — Amendia Interbody Fusion Devices
- K151339 — SONON Ultrasound Imaging System (Model: SONON 300C)
- K151394 — Keeler Slit Lamp
- K151472 — NuVasive CoRoent Lumbar System
- K151526 — Zone, ZoneFree, Zone A1
- K151649 — Valleylab FT10 Electrosurgical Platform
- K151695 — Romeo posterior osteosynthesis system
- K151795 — ML24000 UVA-1 Phototherapy Cabinet
- K151861 — JUSHA-C23C LCD Monitor
- K151944 — Luggie Super
- K151972 — JUSHA-C43 LCD Monitor
- K151982 — Stat Profile Prime ABG Analyzer System
- K152279 — ViZion DR + Wireless
- K152302 — Xenco Medical Cervical Interbody System (Argus)
- K142821 — PAXgene Blood DNA Tube
- K143507 — NFANT Feeding Solution
- K143637 — U&U Sterilization Pouch and Roll
- K150576 — TGM Biolox delta Ceramic Heads
- K151601 — SECURE-LOOP
- K151968 — Cryocare CS-3 Surgical System version 5
- K152268 — VAPRO PLUS POCKET Intermittent Catheter
- K152269 — Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
- K141488 — CAREVIEW 1800R
- K151460 — Fully Automatic Electronic Blood Pressure Monitor
- K151668 — S-scan
- K152286 — LigaSure Curved, Small Jaw, Open Sealer/Divider
- K151595 — On Call Express Pro Blood Glucose Monitoring System
- K143597 — Navigated XIA 4.5 Polyaxial Screwdriver
Data sourced from openFDA. This site is unofficial and independent of the FDA.