FDA 510(k) clearances — page 347
clearances on record, most recent first.
Clearances — page 347
34,601–34,700 of 176,542- 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
- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- K150064 — Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
- K150442 — Volcano Visions PV .018 Digital IVUS Catheter
- K150768 — JuggerKnot Soft Anchors
- K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
- K151160 — Arcus Staple System
- K151248 — PIEZOSURGERY WHITE
- K151249 — PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
- K151270 — CrossTIE Intraosseous Fixation System
- K151442 — TOTAL COMPRESSION PLATING (TCP) SYSTEM
- K151521 — Phoenix Thera-Lase System
- K151538 — NuVasive PEEK Corpectomy Railed System
- K151733 — Xenco Medical Pedicle Screw System
- K151822 — ab medica irrigation/suction gravity system
- K151838 — PRO-TOE Hammertoe Fixation System
- K152015 — Pyrenees Cervical Plate System
- K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K140310 — Peristeen Anal Irrigation System
- K141960 — Exactech® Novation® Crown Cup®
- K142982 — OPUS 5100 Diagnostic Doppler Ultrasound System
- K143631 — Benefix Interspinous Fixation System
- K150265 — Model 206 Electrometer/Dosimeter
- K150812 — Genesys Spine Apache Cervical Interbody Fusion System
- K150852 — SIC 8000
- K151167 — NuVasive PEEK Corpectomy System
- K151440 — Klassic HD Hip System
- K151666 — Leksell GammaPlan
- K151705 — Lotus Posterior Cervical/Thoracic Spinal System
Data sourced from openFDA. This site is unofficial and independent of the FDA.