FDA 510(k) clearances — page 217
clearances on record, most recent first.
Clearances — page 217
21,601–21,700 of 175,699- K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
- K191718 — Buhlmann fCAL turbo and CALEX Cap
- K191998 — Mako Total Hip Application, Mako Total Knee Application
- K192010 — SmoothSkin BARE+
- K192354 — Innovasis Gibralt Spine System
- K190100 — USTAR II System
- K190483 — SPIRA Open Matrix ALIF and LLIF
- K192322 — T-Stat 2.0 Microvascular Tissue Oximeter
- K182671 — Medi-Direct TENS Pen
- K180523 — INTAI Surgery Navigation System
- K181428 — Clyra Wound Irrigation Solution
- K190001 — Supercath 5
- K190856 — SeeFactorCT3
- K191324 — CivaDerm
- K191679 — Omnipod DASH Insulin Management System with interoperable technology
- K191927 — Hinged Laminoplasty System
- K192259 — Philips IntelliSite Pathology Solution
- K192276 — Merge Cardio
- K192296 — Medtronic 6F Taiga Guiding Catheter
- K192301 — BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
- K192332 — ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
- K192402 — syngo.CT Extended Functionality
- K182631 — SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
- K190526 — High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
- K191112 — GEHC DXA Bone Densitometers with enCORE version 18
- K192030 — RS80 EVO Diagnostic Ultrasound System
- K192252 — ProPerformance Recovery System
- K192326 — HardyDisk AST Lefamulin 20µg (LMU20)
- K192344 — Sapphire NC Plus Coronary Dilatation Catheter
- K182292 — VORTRAN APM-Plus
- K183103 — EMS Belt (Model MC0485)
- K183436 — OraCure
- K190563 — 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
- K190858 — Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
- K191113 — geko T-2 and geko T-3 Neuromuscular Stimulators
- K191187 — Dornier MINNOW Ureteral Catheter
- K191232 — AccuCath Ace Intravascular Catheter
- K191357 — Flexible HD Cysto-Urethroscope System
- K191391 — HEDRON Lumbar Spacers
- K191457 — BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
- K191552 — GM501 Mineral Oil
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
- K192065 — Syngo.Via RT Image Suite
- K192254 — InnoSight Diagnostic Ultrasound System
- K181416 — Sapphire Dorsal Comfort Fit
- K183708 — Poly Clear
- K190049 — Sim&Size
- K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
- K191243 — HEDRON Cervical Spacers
- K191253 — Reusable NIBP Cuff
- K191297 — iNSitu Bipolar Hip System
- K191842 — Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
- K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
- K192037 — Advisor VL Circular Mapping Catheter, Sensor Enabled
- K192059 — Bio Guard Air/Water & Suction Valves
- K190507 — Full Automatic (NIBP) Blood Pressure Monitor
- K190708 — AccelFix Lumbar Interbody Fusion Cage System
- K191576 — Mercury® Spinal System, Overwatch® Spinal System
- K191641 — AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws
- K191676 — Intra.Ox 2.0 Handheld Tissue Oximeter
- K191685 — PicoWay Laser System
- K191688 — SubtleMR
- K191800 — Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
- K191378 — 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- K181478 — Roosin Xeroform Petrolatum Dressing
- K182921 — Infinix Universal Composite
- K183364 — Bellavista
- K183586 — CapMedic
- K183670 — Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
- K190005 — Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
- K190288 — Arthrex Tenodesis Button
- K190473 — ACIST RXi System and Navvus II Catheter
- K190830 — TDM Screw Systems
- K190841 — SCENARIA View
- K190869 — Pulse Oximeter
- K190932 — RFID Localization System
- K191021 — Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
- K191273 — Multi-Link X2 ECG and SpO2 Adapter
- K191459 — JuggerStitch Meniscal Repair Device
- K191595 — ARCHITECT STAT High Sensitivity Troponin-I
- K191599 — NICO Myriad NOVUS
- K191801 — PROBEAT-CR
- K191949 — UNFOLDER Vitan Inserter
- K192217 — NCB Plating System Distal Femur and Proximal Tibia
- K192304 — SIS Software Version 3.6.0
- K182257 — UPnRIDE
- K183662 — Saline Wound Wash, SteriCleanse(TM)
- K183695 — OrthoAnalysis Software
- K190002 — Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
- K190398 — Republic Spine Restore Intervertebral Body Fusion System
- K190768 — ARTIS icono
- K190780 — syngo Application Software
- K191148 — Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set
- K191300 — MectaLock Ti Suture Anchor
- K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
- K191516 — Ali Interbody Fusion System
- K191518 — CO2 Laser System
- K191587 — L360 Thigh System
- K191629 — faceLITE
Data sourced from openFDA. This site is unofficial and independent of the FDA.