FDA 510(k) clearances — page 99
clearances on record, most recent first.
Clearances — page 99
9,801–9,900 of 176,479- K231551 — Stethophone
- K231574 — Scenaria View 4.2
- K231708 — Axoguard HA+ Nerve Protector (5 models)
- K231814 — ValvuloPro Valvuloplasty Balloon Catheter
- K232448 — FREEPRINT® splintmaster
- K232802 — TMINI Miniature Robotic System
- K232809 — Cross Vascular RF Generator and Footswitch (optional accessory)
- K232838 — Monkey RingsTM External Fixation System
- K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
- K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty
- K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix
- K223126 — SurgiAid® Collagen Wound Dressing
- K230116 — Vital Spinal Fixation System
- K230148 — Vlab
- K230220 — NeuViz 128 Multi-Slice CT Scanner System
- K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional
- K230897 — Anterion
- K231050 — Arm Blood Pressure Monitor
- K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
- K232090 — JO Coconut Hybrid Warming Personal Lubricant
- K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- K232460 — Disposable electrosurgical pencil (MD1000)
- K232499 — IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
- K232574 — VASSALLO GT Crossing14
- K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30
- K232981 — Synq Software Version 1.3
- K233233 — EMPHASYS Femoral Stems
- K223027 — NeuroTrigger Basic (NTB)
- K230130 — Micromate Navi+
- K230916 — WeSensor
- K230961 — Zeus Spinal System
- K231413 — IPD Dental Implant Abutments
- K231658 — VEOS Spinal Fixation System
- K232341 — CarboClear® Pedicle Screw System
- K232471 — Vy Spine VyLam Laminoplasty System
- K232775 — ID NOW Influenza A & B 2
- DEN220087 — Edison System
- K221777 — Disposable Sterile Syringe
- K223802 — accufit
- K223905 — Vivio® LVEDP System
- K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- K230091 — THE Cover
- K230144 — Denti.AI Detect
- K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- K230777 — Patient Examination Gloves
- K230853 — EARP Nerve Cuff Electrode
- K231300 — Nutricair Enteral Syringe with ENFit
- K231603 — Standard Staple-Line Reinforcement (SSLR23)
- K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom)
- K232044 — Invictus Robotic Navigation Instruments
- K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
- K232055 — Vial Adapter
- K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
- K232173 — Ascend VBR System, Ascend NanoTec VBR System
- K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
- K232407 — Cautery Protective Actuation System (CPAS)
- K232411 — JuggerKnot Soft Anchor OC
- K232480 — ProtekDuo Veno-Venous Cannula Sets
- K232492 — 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor
- K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures
- K232760 — Swoop® Portable MR Imaging System®
- K232787 — ScanNav Anatomy Peripheral Nerve Block
- K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
- K221550 — Evidence MultiSTAT DOA Urine MultiPlex
- K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
- K230070 — MESORAM® Hypodermic Needle (13+ models)
- K230242 — OsteoCentric Dental Implant System
- K230780 — MFG-05
- K231001 — DeepTek CXR Analyzer v1.0
- K231078 — All-Suture Anchor
- K232279 — LifeStyles NRL Textured Condom
- K232367 — cmAngio® V1.0
- K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
- K232675 — Heating Tens, FT-615
- K232704 — Clarius Ultrasound Scanner
- K233044 — Tandem Mobi insulin pump with interoperable technology
- DEN230002 — DuraGraft
- K230135 — Copioumed Chemotherapy Isolation Gown
- K231025 — EFAI NeuroSuite CT ICH Assessment System
- K231398 — VUNO Med-DeepBrain
- K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
- K232023 — Momentum Spine
- K232763 — Electrode Handpieces (VCT, RFTV, BMDT series)
- K232767 — Nautilus VF ECMO Oxygenator
- K232844 — The IQoolTM System
- K230085 — Lung-CAD
- K231772 — V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
- K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
- K232094 — Orchid Safety Release ValveTM
- K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE +23 more
- K232406 — KARL STORZ OR1 SCB CONTROL (WU300)
- K232712 — uMI Panorama
- K232722 — endo.digital Platform
- K232762 — dS Breast Coil 7ch 1.5T
- K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) +2 more
- K232918 — enspire 300 Series Automated Endoscope Reprocessor
- K221972 — Warantec Custom Abutment
- K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
- K231520 — tmCMF Solution
- K231716 — OsteoFlo® HydroPutty
Data sourced from openFDA. This site is unofficial and independent of the FDA.