FDA 510(k) clearances — page 284
clearances on record, most recent first.
Clearances — page 284
28,301–28,400 of 175,699- 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
- K170249 — GRAVITY Syndesmosis LP
- K170372 — SpiralTech Dental Implant System
- K170794 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
- K171284 — FIBERGRAFT BG Matrix Bone Graft Substitute
- K171586 — Smart External Drain (SED) System
- K171612 — ACUITY Pro Lead Delivery System
- K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- K171680 — Infinity-Lock 3, Infinity-Lock 5
- DEN160047 — ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
- K161710 — SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL
- K162822 — ADAMS A1c HA-8180V, CALIBRATOR 80
- K163011 — PHA S1 Spinal System
- K163212 — Parietene DS Composite Mesh
- K163397 — SMR Hybrid Glenoid System
- K163524 — Vessel Dilator
- K170684 — Firebow Wire Torque Assist Device
- K170896 — Admira Fusion x-base
- K170940 — Rickettsia Real-time PCR Assay
- K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
- K171533 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K163153 — Livia
- K170122 — Delta III Lithotripter
- K170213 — SupraSDRM Biodegradable Matrix Wound Dressing
- K170830 — Unison-C Anterior Cervical Fixation System
- K171239 — TULA Tube Delivery System
- K162874 — Cannulated Screws Neoortho
- K163216 — Pinpoint GT Needles
- K163432 — Stellar LEAP
- K170297 — Tranquil Interbody System
- K170708 — OWL RF INSULATED CANNULAE
- K170735 — Powder-Free Clear Vinyl Patient Examination Gloves
- K170817 — Halcyon
- K171163 — Contact Lens Case Round Glasses
- K171536 — RayStation
- K171590 — Distal Elbow Plating System
- K171794 — Smith & Nephew 25 Fluid Management System
- K162797 — SpringTMS
- K170045 — Swedge Pedicle Screw Fixation System
- K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
- K170444 — PROCOTYL® PRIME Acetabular Cup System
- K170568 — CardioLogs ECG Analysis Platform
- K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
- K170962 — NuVasive® CoRoent® Thoracolumbar System
Data sourced from openFDA. This site is unofficial and independent of the FDA.