FDA 510(k) clearances — page 292
clearances on record, most recent first.
Clearances — page 292
29,101–29,200 of 176,542- 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 +1 more
- 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 +1 more
- K170768 — Mini Needle
- K171034 — M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
- K171078 — TRI-COMBO PARASITE SCREEN
- K171092 — XiniWave II Model ECS322P
- K160337 — Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
- K161349 — Everyway Incontinence Stimulation System
- K162992 — Karl Storz UROMAT E.A.S.I.
- K163035 — DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
- K163584 — M3290B Philips IntelliVue Information Center iX
- K163648 — Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
- K170480 — Models 3543A, 4343A, 2929A and A843B
- K170541 — Anorganic Bone Mineral in Delivery Applicator
- K170941 — RX NC Takeru PTCA Balloon Dilatation Catheter
- K171046 — SeaSpine Cambria System
- K171069 — ZELTIQ CoolSculpting System
- K171087 — AXON IR Heat Lamp
- K171339 — EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
- K171448 — Hammertoe Correction System
- K171454 — Interject Injection Therapy Needle Catheter
- K171461 — SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
- K171698 — Smart Syringe
- K171711 — Thunder, Thunder VT, Thunder HR
- K161394 — HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
- K162190 — Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
- K162398 — CO2 Laser Therapy Systems
- K162609 — ClearPath Aligner
- K170143 — GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,
- K170224 — Spider Cervical Plating System
- K170399 — Endoskeleton TO Interbody Fusion Device (IBD)
- K170567 — Tempus Pro Patient Monitor
- K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
- K170815 — PSA Cable
- K170870 — Site~Rite Halcyon Diagnostic Ultrasound System
- K171031 — CRESCENT Spinal System
- K171055 — Philips BlueControl
- K171398 — Dermal Cooling System
- K171666 — MPR2 logO DATALOGGER
- K170239 — Leica FL560
- K170549 — TOKUYAMA CUREGRACE
- K170969 — Eclipse Treatment Planning System
- K171669 — g.Nautilus PRO
- K170434 — Enterprise Imaging XERO Viewer 8.1
- K170706 — Equashield Closed System drug Transfer Device (CSTD)
- K170844 — Gemini-C Hybrid Cervical Interbody System
- K170871 — DigniCap Scalp Cooling System
- K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
- K171267 — NavLock Trackers
- K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
- K171613 — ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
- DEN160012 — D2 Dressing
- K160553 — DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S
- K162572 — NextDent Denture, E-Denture
- K162640 — iVitri EZ
- K162794 — Gelweave Vascular Grafts
- K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
- K170177 — Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
Data sourced from openFDA. This site is unofficial and independent of the FDA.