FDA 510(k) clearances — page 205
clearances on record, most recent first.
Clearances — page 205
20,401–20,500 of 176,479- K192016 — SMOOV O10
- K200303 — Reform Pedicle Screw System
- K200749 — CUBEScan BioCon-900S
- K200864 — 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
- K201124 — TOPAZ Mobile DR System
- K191906 — MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
- K193404 — UF(II) Bar holder abutment
- K193553 — VarseoSmile Temp
- K200056 — Catalys Precision Laser System
- K200390 — V.A.C. DERMATAC Drape
- K200431 — 3D GraftRasp System
- K200878 — Natus NeuroWorks
- K201062 — syngo Ultrasound Apps Suite (sUSAS)
- K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
- K191745 — Medtronic Commander Flex
- K193058 — SonarMed AirWave Airway Monitoring System
- K193122 — Biocore9 Humeral Resurfacing System
- K193334 — Pristina Serena Bright
- K200287 — BP-BT Kiosk
- K200479 — AquaPulse Auxiliary Water Connector
- K200746 — IPL Treatment Systems
- K200747 — PuriLens Plus Preservative Free Saline
- K191819 — Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
- K191826 — KeYi Total Hip System
- K192048 — Single Use Endoscope Valves Set
- K192463 — PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
- K192694 — PAL Single-Use Cannulas
- K193096 — S.I.N. Dental Implant System
- K193293 — XV Lung Ventilation Analysis Software
- K193436 — VITA Ambria
- K200169 — VFS1 Bipolar Electrosurgical Generator
- K200317 — Support Catheter
- K200367 — Distal Humerus Plating System
- K200700 — Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
- K200701 — Skeletal Dynamics Midshaft Humerus Plating System
- K200989 — Reliance Endoscope Processing System
- K200997 — Lumipulse G CA19-9-N
- K201034 — Syngo.CT CaScoring
- K201053 — PercuNav Image Fusion and Interventional Navigation
- K190118 — Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
- K192642 — 308nm Excimer System
- K193055 — Purzir Dental Zirconia
- K200124 — InCore MPJ System
- K200205 — Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K200991 — EVOL Spinal Interbody System
- K201011 — Medtronic Model 5392 External Pulse Generator (EPG)
- K192222 — EZ-Inject Single use Needle
- K192901 — HealthVCF
- K192930 — Dymaxeon Spine System
- K193457 — AUDERE Lumbar Spacer System
- K200026 — Disposable ECG Cable
- K201043 — Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
- K201136 — Cure Lumbar Plate System
- DEN190031 — NP Screen
- K192103 — Thunderbeat Open Fine Jaw Type X Hand Instrument
- K192244 — Arcad SmileStudio and Aligner System
- K193043 — Critical Alert CommonPath Enterprise
- K193085 — PuraDERM Gel
- K200213 — Biograph mMR with syngo MR E11P-AP01 system software
- K200290 — Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
- K200501 — ArtiSential Laparoscopic Instrument-Electrodes
- K200841 — Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
- K200659 — Dermalux Tri-Wave MD
- K192209 — Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
- K192218 — Custom Legacy and Custom InterActive Titanium Abutments
- K193016 — PRECICE Bone Transport System
- K193617 — Precice® Screws
- K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
- K200640 — ALTAPORE SHAPE
- K200935 — Mazor X
- K200950 — Ventricular Catheter
- K200961 — Treace Medical Concepts (TMC) Plating System
- K200964 — Sonosite PX Ultrasound System
- K192577 — Actreen Hi-Lite Intermittent Urinary Catheters
- K192651 — ZAGA Zygomatic System
- K192693 — Nuvo Nano Portable Oxygen Concentrator
- K192866 — Chemfort CSTD
- K192972 — Patient Monitor
- K193535 — EZER, Portable X-ray System
- K200120 — LiteSaber Wire Torque Assist Device
- K200146 — HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
- K200395 — LOSPA II Knee System (EXULT Knee Replacement System)
- K200435 — Catalyst+, Catalyst+ HD
- K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
- K200653 — AMF Revision TT Cones
- K200699 — HS70A Diagnostic Ultrasound System
- K200966 — Icare HOME Tonometer
- K192069 — Aerodentis System
- K192283 — MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
- K192586 — LIAISON® Folate
- K193189 — RFID Localization System
- K193420 — XO Cross Support Catheter
- K193496 — CharmFil
- K201058 — Accuvue+
- K191590 — AA temp temporary restoration 3D printing photoreactive resin
- K193176 — uMR 780
- K193220 — AVIEW LCS
- K200293 — InMode System with vTone Applicator
- K200315 — Ziostation2
Data sourced from openFDA. This site is unofficial and independent of the FDA.