FDA 510(k) clearances — page 197
clearances on record, most recent first.
Clearances — page 197
19,601–19,700 of 175,699- K200252 — Getinge Assured MI Steam Migrating Integrator
- K200274 — CariCloud
- K200400 — Systane iLux2
- K200468 — V30 system, V20 system, V10 system, V-FC Handpiece
- K200483 — SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
- K200662 — X-Guide® Surgical Navigation System
- K200737 — SPY Portable Handheld Imaging (SPY-PHI) System
- K200751 — Photodynamic Therapy (PDT) Equipment
- K200956 — NuVasive Thoracolumbar Plates
- K200969 — NEXXT MATRIXX System
- K200995 — Insignia Anterior Cervical Plate System
- K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
- K201086 — Advincula Delineator Uterine Manipulator
- K201106 — IntraMarX 3D Radiopaque Marker
- K191362 — LifeFlow Blood System
- K192399 — Infinity Angioplasty Balloon Catheter
- K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
- K200352 — Axis Spine Technologies ALIF
- K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
- K201078 — NuVasive® ACP System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.