FDA 510(k) clearances — page 109
clearances on record, most recent first.
Clearances — page 109
10,801–10,900 of 176,479- K230935 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
- K230944 — MeMed BV
- K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
- K231252 — Ventana L Spinal System
- K231264 — Easy On Universal Glaze & Stain
- K231267 — ClearTip
- K231585 — Vantage PSI System
- K231588 — ViewFlex Eco Reprocessed ICE Catheter
- K231596 — IOB Temperature Management System
- K231689 — iFuse TORQ® Implant System
- DEN200052 — KidneyIntelX.dkd
- K221436 — F&P 950 Accessory Breathing Circuit Kits
- K222933 — MYAH
- K223047 — NeuroSwift Pro
- K223596 — SQ.line KERRISON
- K230176 — Upper Arm Blood Pressure Monitor
- K230337 — EarliPoint
- K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
- K230595 — OsteoCentric ACL Fixation System
- K230866 — HotDog Warming Mattress + Return Electrode
- K231101 — Flume Catheter
- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K231553 — OverStitch NXT Endoscopic Suturing System
- K231647 — XENOVIEW 3.0T Chest Coil
- K231691 — Phantom XL Insulated Dilators
- K210924 — e-Celsius Medical System
- K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
- K220198 — Medi Lift PLUS
- K223722 — MIO Blood Glucose Monitoring System
- K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
- K230859 — Aneroid Sphygmomanometer
- K231232 — Curiteva Laminoplasty System
- K213046 — AceConnex Pre-Sutured Fascia
- K222492 — Hope&Her Vaginal Dilators
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K230706 — EMBOLD Soft Detachable Coil System
- K230861 — VADER® Pedicle System Navigated Instruments
- K230876 — RI.KNEE Adjustable Tibia Cut Guide
- K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
- K231219 — NobelZygoma PureSet Tray
- K231636 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
- K221488 — Z7 Zirconia Implant System
- K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
- K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical System
- K223143 — SAGICO Spinal System
- K230492 — Avitus® Precision Autograft Delivery System
- K230867 — Bone Bolt System
- K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113) +2 more
- K231215 — IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
- K222142 — BR SLA Type Implant System
- K220955 — Hudson RCI Variable concentration Large Volume Nebulizer (1770)
- K221411 — Surflo Winged Infusion Set
- K221827 — Mais Central Venous Catheter
- K222323 — Black Diamond
- K222592 — AltiVate® Anatomic Shoulder AG e+ with Markers
- K222969 — FERTI-LILY Conception Cup
- K222982 — Virtus Metabolic Monitor
- K223013 — AccurECG Analysis System
- K223019 — sam 2.0 Long Ultrasound Device
- K223048 — Medisystem Pacs
- K223159 — Radixact Treatment Delivery System
- K223187 — HemosIL Liquid Anti-Xa
- K223638 — Neodent Implant System - Helix Short Implant System
- K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
- K230160 — VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
- K230276 — TECHFIT DISRP® System
- K230359 — KOH Ultramicro Injection Cannula (26167NN) +11 more
- K230369 — EUROPA Navigated Instruments
- K230410 — DD medical polymers (PMMA)
- K230518 — HydraDose Vaginal Suppositories
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
- K231117 — neXus Ultrasonic Surgical Aspirator System
- K231153 — Neuhat Hair Growth System; ibeauty.com Laser Cap
- K231185 — MapRT
- K231505 — GORE® ACUSEAL Vascular Graft
- K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP)
- K222932 — INVOcell Intravaginal Culture System
- K223083 — Straumann SLActive labeling changes
- K223379 — Portable Oxygen Concentrator (Model: P2-E7, P2-E)
- K223558 — CUVIS-spine
- K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R +1 more
- K223871 — Miria Skin Treatment System
- K230322 — SelectFlex Neurovascular Access System Family
- K230444 — Talee, Talee PostOp
- K230497 — Bladder AI (AIBV01)
- K230599 — TargetCool
- K230904 — Arthrex Virtual Implant Positioning (VIP) System
- K231131 — Diode Laser Body Sculpture Systems
- K231202 — QuickRayPRO
- K221311 — Antibacterial Bandage
- K222658 — Accurate 24 Non-invasive blood pressure monitor
- K223033 — Tixel® 2 System
- K223248 — Tablo® Hemodialysis System
- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1) +4 more
- K230506 — PureLift Pro Edition
- K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K231031 — ACL TOP Family 70 Series
- K231212 — da Vinci E-200 Electrosurgical Generator
- K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
Data sourced from openFDA. This site is unofficial and independent of the FDA.