Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
32881–32904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2016
CapsoCam (SV-1)
K151635 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 237d
Cleared Feb 09, 2016
Actreen Mini Intermittent Urinary Catheters
K151772 · GBM
B.Braun Medical, Inc.
Gastroenterology & Urology · 224d
Cleared Feb 09, 2016
Powder Free Nitrile Patient Examination Gloves, Black color
K152271 · LZA
Suqian Xingye Glove Co,Ltd
General Hospital · 181d
Cleared Feb 09, 2016
ENDOFLOW II - Irrigation, Warming and Suction System
K152278 · OCX
Promepla Sam
Gastroenterology & Urology · 181d
Cleared Feb 09, 2016
OBS Anchorage Screw
K152297 · OAT
Bomei Co, Ltd.
Dental · 180d
Cleared Feb 09, 2016
Exofin High Viscosity Tissue Adhesive
K152476 · MPN
Chemence Medical Products, Inc.
General & Plastic Surgery · 162d
Cleared Feb 09, 2016
Dictum Health
K152645 · MWI
Dictum Health, Inc.
Cardiovascular · 146d
Cleared Feb 09, 2016
Electronic Thermometer
K152739 · FLL
Guangdong Biolight Meditech Co., Ltd.
General Hospital · 139d
Cleared Feb 09, 2016
DIODE LASER THERAPY SYSTEMS
K152898 · GEX
Beijing Sincoheren Science and Tech....
General & Plastic Surgery · 131d
Cleared Feb 09, 2016
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
K153066 · HQD
Boston Foundation For Sight
Ophthalmic · 110d
Cleared Feb 09, 2016
Epic Extremity Plate System
K153340 · HRS
Epic Extremity, LLC
Orthopedic · 82d
Cleared Feb 08, 2016
EndoChoice Select Injection Needle
K151475 · FBK
Endochoice, Inc.
Gastroenterology & Urology · 251d
Cleared Feb 08, 2016
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
K152743 · KCT
Microline Surgical, Inc.
General Hospital · 138d
Cleared Feb 08, 2016
ExpressBraid Graft Manipulation
K152868 · GAT
Biomet Manufacturing Corp
General & Plastic Surgery · 131d
Cleared Feb 08, 2016
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
K160068 · OCC
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Feb 05, 2016
MINIARS SCREWS
K143596 · HWC
Overmed Srl.
Orthopedic · 414d
Cleared Feb 05, 2016
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
K151069 · BSP
Spectra Medical Devices, Inc.
Anesthesiology · 290d
Cleared Feb 05, 2016
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX...
K151185 · FRO
Abl Medical, LLC
General & Plastic Surgery · 277d
Cleared Feb 05, 2016
Vital Signs Patch System
K151835 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 214d
Cleared Feb 05, 2016
YuGo System
K151955 · LXJ
Biogaming , Ltd.
Physical Medicine · 205d
Cleared Feb 05, 2016
Love Liquid Personal Lubricant
K152168 · NUC
The Kama Sutra Company
Obstetrics & Gynecology · 185d
Cleared Feb 05, 2016
PC ECG
K152427 · DPS
Edan Instruments, Inc.
Cardiovascular · 163d
Cleared Feb 05, 2016
Amecath Peripheral inserted Central Venous Catheter Sets
K152819 · LJS
Ameco Medical Industries
General Hospital · 130d
Cleared Feb 05, 2016
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
K153028 · LYZ
Zibo Huiying Medical Products, Co. ,...
General Hospital · 112d