FDA 510(k) clearances — page 240
clearances on record, most recent first.
Clearances — page 240
23,901–24,000 of 175,699- K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses
- K182680 — KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
- K182926 — IntelliSpace Radiology
- K183040 — Zenition 70
- K183098 — Senhance Surgical System
- K183116 — Unity Network ID
- K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
- K180653 — Spartan eCoil System
- K181336 — HS50 / HS60 Diagnostic Ultrasound System
- K181825 — CAAS MR Solutions
- K181935 — Endoform Reconstructive Template - Non Absorbable
- K181970 — MectaLIF Posterior Extension
- K182076 — Elekta Unity
- K182479 — NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
- K182949 — Healix Compression Screw System
- K183034 — MOSAIQ Oncology Information System
- K183037 — Monaco RTP System
- K183065 — Coolrail Linear Pen
- K183069 — NobelZygoma 0°
- K183191 — 6420 Ultrasound System
- K173083 — IMPLANTER DENTAL PLANNING SOFTWARE
- K181159 — LZI Fentanyl Enzyme Immunoassay
- K181908 — Action Trackchair
- K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
- K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup
- DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- K173495 — Single Use Hot Biopsy Forceps FD-231
- K173589 — Prizma
- K180298 — welloStationX
- K180388 — Transcend 365 miniCPAP System
- K180482 — ZOLL Propaq M
- K180495 — Tinnitus Sound Generator Module
- K180792 — Arterial Pressure Monitoring Set/Tray
- K180840 — UNO Negative Pressure Wound Therapy System
- K180918 — Planmed Verity
- K181221 — BD PhaSeal Optima Closed System Transfer Device
- K181286 — Ambu aScope RLS Slim
- K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
- K181588 — POPS! one Blood Glucose Monitoring System
- K181696 — ChitoZolve
- K181784 — Spectra S3 Plus
- K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
- K182218 — FerriSmart Analysis System
- K182245 — EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
- K182249 — Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
- K182336 — SubtlePET
- K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
- K182498 — Advanced Skin Renewing Device
- K182600 — Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
- K182663 — Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
- K182797 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
- K182815 — XVWeb 3D
- K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K173701 — Implant-One System
- K180685 — AS-3XX Series Fingertip Pulse Oximeter
- K181427 — BD MAX Enteric Viral Panel, BD MAX Instrument
- K181667 — Thoraguard System
- K181816 — Ceramic Denture Zirconia Ceramics Block
- K181880 — VivaSight-SL (TVT) system
- K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
- K182181 — Persyst 14 EEG Review and Analysis Software
- K182418 — V3 Segmental Plating System
- K182587 — Device Electrosurgical Generator ESG-150
- K182757 — Espire Elbow Pro, Espire Elbow Hybrid
- K182988 — Afinion HbA1c Dx on Afinion 2
- K180207 — Non-contact Infrared Thermometer
- K180498 — NuVasive Reline Fenestrated Screws, High V+ Bone Cement
- K180665 — SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
- K181604 — Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
- K181693 — SMS Femoral Stem
- K182380 — AEON Endoscopic Stapler
- K182992 — BGM014 Blood Glucose Monitoring System
- K183010 — Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
- K182169 — AdVance XP Male Sling
- K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
- K182369 — gammaCore Sapphire
- K182746 — ATEC ALIF and LLIF Spacer System
- K182764 — Biop Digital Colposcope
- K182801 — Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
- K182983 — iFuse Implant System®
- K172837 — Low-frequency Multi-function physiotherapy instrument
- K181112 — Orchestrate 3D
- K182134 — ARiX RAD Radiographic System
- K182324 — EkoSonic Endovascular System
- K182346 — TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
- K182431 — Konicaminolta DI-X1
- K182470 — Plateau Spacer System
- K182699 — Selethru PTCA Balloon Dilatation Catheter
- K183009 — HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
- K183013 — Vitrea Software Package, VSTP-001A
- K183038 — Corin Optimized Positioning System (OPS) Plan
- K183159 — 3M Clarity Aligners
- K183174 — FlexCath Advance Steerable Sheath and Dilator
- K180430 — Digistat Smart Central
- K180557 — Greene Renal Transplant Stent Set
- K180573 — Responsive Arthroscopy Interference Screw System
- K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
- K180643 — MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
- K181381 — A.B. Dental Devices Dental Implants System
Data sourced from openFDA. This site is unofficial and independent of the FDA.