FDA 510(k) clearances — page 108
clearances on record, most recent first.
Clearances — page 108
10,701–10,800 of 175,620- K230069 — S.I.N. Dental Implant System
- K230097 — IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
- K230169 — EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
- K230313 — QUANTUM Patient Specific Instrumentation (PSI) System
- K230341 — ACRIFIX
- K230640 — Affinity Fusion Oxygenator System
- K211556 — N2
- K214009 — D·Kaptain PTA High Pressure Balloon Dilatation Catheter
- K221118 — CO2 Mainstream Sensor
- K221493 — MicroScan Prompt Inoculation System-D
- K221537 — Nightwear Aligners
- K222012 — FAQ 101
- K222677 — Intermittent nelaton catheter for single use
- K223256 — Optimos Cystotome
- K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing
- K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
- K230033 — Da Vinci SP Surgical System (SP1098)
- K230035 — BioSci Disposable Virus Sampling Tubes
- K230107 — Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
- K230336 — CurrentBody Skin Led Hair Regrowth(Model: MZ-07)
- K230689 — T-FIX 3DSI Joint Fusion System
- K213584 — Reprocessed NRG Transseptal Needle
- K220142 — BRM Digitalis Spacer
- K230029 — NeuroStar Advanced Therapy System (Version 3.7)
- K230385 — Ballancer Platinum (1222)
- K213749 — G7, Dental Operative Unit and Accessories
- K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
- K222006 — Sclerotherapy & Endoscopic Needles
- K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
- K223240 — Annalise Enterprise CTB Triage Trauma
- K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- K222370 — SpO2 Extension Cable
- K221734 — Maxtec MaxO2 ME+p
- K230568 — FiberTak Suture Anchor
- DEN200011 — Masimo SafetyNet
- K211059 — CereFlow V1.2
- K213272 — Formus Hip
- K213660 — RadAlly
- K220068 — Butterfly iQ/iQ+ Ultrasound System
- K220780 — ROVO Mechanical Thrombectomy Device
- K223017 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
- K223570 — SonoAir Series Digital Color Doppler Ultrasound System
- K223778 — Diode Laser Hair Removal System (RD-SLD600)
- K230003 — Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K230021 — IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
- K230022 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
- K230041 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K230238 — BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
- K230274 — Medical Diode Laser (M2)
- K230312 — Iris AirShuttle
- K230356 — Aspirex Thrombectomy System
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- DEN210039 — SNOO Smart Sleeper
- K220088 — Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K221320 — Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
- K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
- K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
- K222112 — Comfort Marker 2.0
- K223326 — Axiom PSR System
- K223342 — MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
- K223377 — BIASURGE Advanced Surgical Solution
- K223422 — Emory Cardiac Toolbox 4.3
- K223853 — Medartis APTUS® Ulna Plates
- K223923 — HOPKINS Telescopes
- K230161 — ONLINE TDM Phenytoin - Free Phenytoin application
- K230555 — Cemented Tibia Baseplate no Taper with JRNY Lock
- K230590 — ARDO Bellis
- K230636 — Maestro Microcatheter
- DEN220030 — RemeOs Screw LAG Solid
- K212423 — EndoDrill® Model X
- K213815 — SiJoin®T3
- K221984 — InterView XP; InterView FUSION
- K222312 — RayStation 12A
- K222397 — KLS Martin Level One Rib Fixation System
- K222485 — SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
- K222871 — Stethophone v1
- K223305 — Trevo NXT ProVue Retriever
- K223611 — Calibrate LTX Interbody System
- K223915 — Tactoset
- K223916 — PUMA-G System
- K230243 — ROSA® Knee System
- K230527 — WishBone Medical Plate and Screw System
- K213867 — Carestation 750/750c
- K220226 — X-Y Lubricating Jelly
- K221921 — DTX Studio Clinic 3.0
- K221938 — KLS Martin Pure Pectus System
- K221995 — Gas Insufflator
- K222146 — Disposable Endoscopic Hemoclip
- K222174 — RadioLens v1.0
- K222179 — Annalise Enterprise CXR Triage Trauma
- K222260 — Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
- K222268 — Annalise Enterprise CXR Triage Trauma
- K222729 — Electrical Scooter, WT-T4QP2
- K223343 — MAGNETOM Amira; MAGNETOM Sempra
- K223625 — CapnoSpot Pneumothorax Decompression Indicator
- K223928 — Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
- K230026 — SQUALE
- K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K230255 — Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
Data sourced from openFDA. This site is unofficial and independent of the FDA.