FDA 510(k) clearances — page 283
clearances on record, most recent first.
Clearances — page 283
28,201–28,300 of 175,699- K171439 — EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
- K171616 — Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
- K171701 — GelPOINT Path Transanal Access Platform
- DEN170022 — QuantX
- K163159 — Dario Blood Glucose Monitoring System
- K163388 — XPress BCD Breast Compression Device
- K163687 — OLINDA EXM
- K170182 — CARDIOVIT FT-1
- K170379 — Disposable Standard Clamp
- K170675 — Graftgun Universal Graft Delivery System
- K170775 — Mini Stick ENVI Non-Vascular Introducer Kit
- K170852 — POD Packing Coil
- K170978 — Embrace Neonatal MRI System
- K171093 — STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
- K171290 — Vela RX PTA Balloon Dilatation Catheter
- K171812 — Nio Color 2MP (MDNC-2123)
- K171838 — TiLock2 Spinal System
- K171957 — MaxZero Extension Sets with Needless Connector
- K162510 — Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
- K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
- K163064 — Demi Ultra
- K163714 — OSSIX BONE
- K170100 — CreoDent Solidex Customized Abutment and Screw
- K170729 — Examion X-AQS
- K170786 — Faxitron Bioptics Speciemen Radiography System
- K171021 — JO Agapé Personal Lubricant
- K171149 — Altrix Temperature Management Wraps
- K171333 — 20G x 5/8 Pro-Lock CT Safety Infusion Set
- K171544 — Arterys Viewer
- K171807 — ES2 Neuromonitoring Accessory Instruments
- K171824 — Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
- K171844 — Inspire ICE aka Inspire ICE Clear Brackets
- K162957 — U2 Femoral Head
- K170407 — BD ChloraShield IV Dressing with CHG Antimicrobial
- K170607 — !M1
- K170613 — Genius Total Knee System
- K171115 — 3D Endo Software
- K171404 — BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
- K160712 — VITROS Chemistry Products hsCRP Reagent
- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
- K162707 — Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
- K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
- K162853 — Bonafix TWO - Dental Implant System
- K163150 — ViMove2
- K163194 — Neodent Implant System - GM Line
- K163318 — Soules Intrauterine Insemination Catheter
- K170090 — RTHawk, HeartVista Cardiac Package
- K170518 — In2Bones Fracture and Correction System
- K170637 — sensiFirm
- K170686 — Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
- K170710 — True Spinal Fixation System
- K170757 — Aegis Transit System
- K170798 — Dictum Health
- K171029 — eCareCoordinator
- K171128 — SIGNA Premier
- K171242 — Alma LipoFlow System
- K171413 — HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System
- K171522 — truFreeze Rapid AV Spray Kit
- K171539 — Contact Lens Case
- K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
- K171907 — Vitality® Spinal Fixation System
- K162815 — SterilContainer S System
- K162878 — Kitazato ET Catheters
- K170550 — Coveris Cervical Cage System
- K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
- K170676 — HD Lumbar Interbody System
- K170808 — Unity Total Knee System
- K170986 — KATANA Zirconia Block
- K171018 — Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
- K171656 — Genesys Spine Apache Interbody Fusion System
- K171749 — Velofix(tm) Interbody Fusion System
- K171813 — OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
- K163057 — Relizorb
- K163137 — NIRA Beauty Skin Laser
- K163504 — Borrelia B31 ViraChip IgG Test Kit
- K163560 — Reprocessed AcuNav Diagnostic Ultrasound Catheter
- K163571 — Great Basin Stool Bacterial Pathogens Panel
- K170318 — NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
- K170435 — NerveGuard NRFit, NerveGuard LUER
- K170507 — Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
- K170999 — P50 Series Digital Color Doppler Ultrasound System
- K171733 — TrueBeam, TrueBeam STx, Edge
- K171766 — Acuson SC2000 Diagnostic Ultrasound System
- K171800 — OEC Elite MiniView
- K162470 — RT300 FES cycle ergometer
- K162881 — Kitazato OPU Needles
- K163353 — Needle's Eye Snare Retrieval Set - 54cm
- K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
- K170503 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
- K170814 — Devon 24
- K171000 — P60 Series Digital Color Doppler Ultrasound System
- K171105 — AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
- K171133 — Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
- K171316 — O2Vent W
- K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
- K171780 — OrthAlign Plus System
- K171908 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
- K162934 — Biodesign Parastomal Hernia Repair Graft
- K170397 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
Data sourced from openFDA. This site is unofficial and independent of the FDA.