FDA 510(k) clearances — page 85
clearances on record, most recent first.
Clearances — page 85
8,401–8,500 of 175,620- K232750 — BTI Interna Prosthetic Components
- K232830 — Vibrant System
- K233261 — Global Modular Replacement System
- K233432 — 10F Sheath and Dilator Set
- K233654 — VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
- K230137 — Reliance® Fusion Sterilization Wraps
- K231127 — S.I.N. Dental Implant System
- K231206 — DLP Silicone Coronary Artery Ostial Cannulae
- K231515 — MySpine Cervical Guides
- K231967 — ARi ExCon Implant System
- K232273 — RM Electrode (RMH 23-01)
- K232381 — LOGIQ Totus
- K232661 — Myocardial Strain Software Application
- K232761 — ProNephro AKI (NGAL)
- K232795 — Led Mask Platinum Exclusive MD
- K232846 — Light Based Hair Removal Device
- K233429 — OTS 25 (100-1)
- K222930 — Evolve Nitric Oxide Delivery System
- K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
- K230712 — SG Lanset I, SG Lancets, Soft Lancets
- K231125 — 2008T BlueStar Hemodialysis Machine
- K231465 — Q-Pad Test System
- K231675 — OneRF Ablation System
- K232206 — SOMATOM Pro.Pulse
- K232769 — BeaMed Laser Surgery Fibers
- K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K233334 — Aquilion Serve SP (TSX-307B/1) V1.3
- K233521 — QT ECG (QTERD100)
- K233562 — LINQ II Insertable Cardiac Monitor
- K233597 — Sonosite LX Ultrasound System
- K222057 — THERMOCLICK
- K223170 — Electronic Blood Pressure Monitor, model: HTD6602US
- K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
- K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
- K231230 — Optina-4C (MHRC-C1N)
- K231615 — Disposable Endoscopic Bipolar
- K231923 — Liberty SI Lateral Implant System
- K232220 — SS Abutment System
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K232440 — Adravision Perio
- K232814 — Electronic Blood Pressure Monitor
- K233335 — Tablo® Hemodialysis System
- K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
- K233568 — Ceevra Reveal 3+
- DEN230045 — Sonu
- K220525 — RESPONDER Polysaccharide Hemostat
- K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- K230648 — Access hsTnI
- K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
- K231895 — Maxtec MaxBlend2+p
- K232308 — Monarch Blood Collection Set
- K232581 — Medical Disposable Sterile Needle Electrode
- K232693 — Tyber Medical Distal Radius Plating System
- K232932 — Intense Pulse Light Therapeutic Apparatus
- K233347 — Verruca-Freeze® H
- K233397 — Cosine-10TM Diagnostic Catheter
- K230391 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube
- K230528 — Extension Set
- K230621 — LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes
- K230639 — Align Cervical Interbody Fusion System
- K230988 — Vial2Bag Advanced® 13mm Admixture Device
- K231057 — Antibacterial Gel Wound Dressing
- K231179 — Slinky Catheter
- K231211 — Medline ComfortTemp Patient Warming System
- K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
- K231476 — TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System
- K231817 — AlignerFlow LC
- K232093 — Woo More Play Coconut Love Oil
- K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14
- K232418 — Single Platform SP1 Implant System
- K232438 — Dental Glass Ceramics Blocks
- K232708 — Intense pulsed light therapy device
- K232758 — Comatryx OTC
- K232856 — Syngo Carbon Clinicals
- K233149 — CATHTONG III Tapered PICC Catheter
- K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
- K233301 — ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
- K233529 — BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K221787 — Auxein's DHS/DCS Plate System
- K230061 — Insulin Syringe
- K230587 — Wrist Pulse Oximeter
- K230669 — L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters
- K231393 — Radical the Dude 7F Guide Catheter
- K231546 — Somfit
- K231877 — NavaClick Injection System
- K232155 — syngo.CT Dual Energy
- K232262 — LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
- K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
- K232709 — Diode laser therapy device
- K232716 — Q-Switched Nd:Yag laser
- K233500 — Benesta Tissue Removal Device
- K233503 — 14F iSLEEVE Introducer Set
- K233545 — EPIQ Series Diagnostic Ultrasound System
- K233552 — IDEAL Ziploop
- K230179 — 6440 MyLabX90
- K230646 — SUREcore Prime Biopsy Instrument
- K230726 — CEREGLIDE 92 Intermediate Catheter
- K231203 — Mosie Baby Kit
- K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
- K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
Data sourced from openFDA. This site is unofficial and independent of the FDA.