FDA 510(k) clearances — page 231
clearances on record, most recent first.
Clearances — page 231
23,001–23,100 of 176,542- K183572 — FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
- K183663 — Microlife Digital Infrared Ear Thermometer
- K190150 — Sage 2-in-1 Personal Lubricant and Moisturizer
- K190163 — ALARA Neuro Access Kit
- K190575 — iBreastExam
- K191287 — OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
- K191325 — EMPOWR Partial Knee
- K191608 — Impress Angiographic Catheter
- K191616 — Orthophos S
- K182158 — UNiD Patient-matched PLIF cage
- K182455 — A.B. DENTAL DEVICES Dental Implants System
- K182814 — Rael Tampon
- K190123 — MicroPort CoCr Femoral Heads
- K190749 — 087 Balloon Guide Catheter System
- K191372 — Lyra
- K191635 — Optilite IgM Kit
- K173974 — DROWZLE
- K183325 — Modus Nav
- K182091 — Osstem Abutment System
- K182714 — Novidia Bulk Fill Flow Composite
- K182930 — PerioLase Nd:YAG Pulsed Dental Laser System
- K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe
- K190457 — VERITON CT whole body SPECT/CT system
- K190972 — Ambu aScope 4 RhinoLaryngo Intervention
- K190976 — Radial Medical Compression System
- K190999 — SureForm 45 Curved Tip, SureForm 45 Gray Reload
- K191050 — MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
- K191259 — Stryker CrossFlow Integrated Arthroscopy Pump
- K191272 — Wearable Device, Wearable Package
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
- K191317 — StitchKit
- K191585 — iNtuition-Structural Heart Module
- K191601 — Valleylab FT10 Electrosurgical Platform
- K181418 — ScopeFlow Pure(TM)
- K181457 — EndoStream(TM)
- K182854 — GC FujiCEM 2 (Improved)
- K190229 — Stryker PEEK Customized Cranial Implant Kit
- K190694 — Unifi Workspace v1.0.0
- K190718 — Zygomatic Implants
- K190960 — Nalu Lead Blank (50cm)
- K191138 — AeroForm Tissue Expander, Smooth
- K191482 — Senhance Surgical System
- K191534 — ID NOW Influenza A & B 2
- K191579 — Voyant System
- K191594 — Nuvis Battery Arthroscope
- K182471 — Scooter
- K182829 — Scepter Mini Occlusion Balloon Catheter
- K182875 — DeepCT
- K183041 — Full Digital Colour Doppler Ultrasonic Diagnostic System
- K183079 — Conometric Abutments
- K183243 — Velofix TLIF Cage
- K183322 — physIQ Heart Rhythm and Respiratory Module
- K190011 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
- K190107 — VeriSplint
- K190137 — Identify
- K190528 — MariGen Wound Extra
- K190620 — SpeediCath Flex Coude Pro
- K190801 — PressOn Electrode Headset
- K190818 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K191045 — Salvo Spine System
- K191408 — Nexxt Matrixx System
- K191541 — Vave Personal Ultrasound System
- K191557 — CentriMag Acute Circulatory Support System
- K191589 — Calprest, EasyCal
- K191592 — CalprestNG, EasyCal
- K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
- K181957 — Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
- K182163 — Shear Stress Therapeutics SST 3000
- K183623 — LifeSPARC Pump, LifeSPARC Controller
- K190969 — ENDOSCOPE REPROCESSOR OER-Elite
- K191162 — EpiLaze Multi-wavelength Laser
- K191252 — Gem FlowCoupler System
- K180365 — PRAMA White Implant Systems
- K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®)
- K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
- K182615 — Surgikor Dental Implant System
- K183050 — GLISSANT Intimate Lubricant
- K183153 — Microwave Ablation System
- K190064 — nView system 1
- K190277 — ProVate Vaginal Support
- K190286 — Materialise Glenoid Positioning System
- K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- K191384 — RayCare 2.3
- K191580 — BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
- K182414 — Aesculap® SterilContainer(TM) S2 System
- K182901 — Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
- K182904 — syngo.MR Applications
- K190174 — Miethke Shunt System GAV 2.0 and SA 2.0 Valves
- K190254 — Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
- K190324 — OrthoPediatrics Cannulated Screw System
- K190456 — BTL 799-2L
- K190498 — Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
- K190548 — BIOMONITOR III, Remote Assistant III
- K190594 — AngioVac C20, AngioVac C180
- K190645 — Arthrex NanoScope System
- K190924 — Revitive Medic Plus, Revitive Advanced 2
- K191238 — Zimmer Guide Wire Devices
- K191367 — Harrier-SA Lumbar Interbody System
- K183149 — Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
- K190950 — Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Data sourced from openFDA. This site is unofficial and independent of the FDA.