FDA 510(k) clearances — page 117
clearances on record, most recent first.
Clearances — page 117
11,601–11,700 of 176,479- 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 +1 more
- 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
- K230271 — ISOLIS Cryoprobe
- K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K200452 — Meril-Bonewax
- K222746 — Overjet Caries Assist
- K223192 — XT Stain/Glaze
- K223365 — RODIN Palette Naturalizing Kit
- K223581 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K223823 — Disposable Surgical Face Mask
- K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
- K220644 — Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
- K230046 — Vinyl examination gloves
- K220212 — BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
- K221589 — Starly pad
- K222559 — BD BACTEC Myco/F Lytic Culture Vials
- K222591 — BD BACTEC Plus Aerobic/F Culture Vials
- K223076 — BD Texium Closed Male Luer
- K223236 — Medline Surgical Face Mask and Medline Procedural Face Mask
- K223323 — Blood Collection Needle (with/without Needle Holder)
- K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K230002 — Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
- K230206 — Entarik Feeding Tube System
- K230382 — 3 Series NeoLux
- K230461 — Quantra Hemostasis Analyzer
- K230474 — EVA5 Insufflator
- K230797 — SmartMTA Capsule
- K212121 — VHT-200 Wound Treatment System
- K212207 — Sterile Hypodermic Syringe for Single Use
- K212394 — Implant-One Multi-Unit Abutment
- K221585 — 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
- K221805 — AccurSound Electronic Stethoscope AS-101
- K222096 — Endo Ultrasonic Activator
- K222105 — RESPONSE 5.5/6.0 Cannulated Screw System
- K222151 — Sterilization Wrap
- K222332 — MeMed BV
- K222367 — SAVE GBR
- K222423 — Fixone All Suture Anchor
- K222620 — Sterilized Latex Surgical Gloves
- K222859 — 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
- K223419 — Triever16 Curve
- K223441 — SpaceFlex Acetabular Cup
- K223488 — ClosureFast Endovenous Radiofrequency Ablation Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.