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
40849–40872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2013
TRANSCORP ACIF SYSTEM
K121178 · ODP
Transcorp, Inc.
Orthopedic · 443d
Cleared Jul 05, 2013
ISUS IMPLANT SUPRASTRUCTURES
K122424 · NHA
Dentsply International, Inc.
Dental · 330d
Cleared Jul 05, 2013
ERMIS STERILIZATION CONTAINER SYSTEM
K123234 · KCT
Ermis Medizintechnik
General Hospital · 263d
Cleared Jul 05, 2013
ETII SA FIXTURE SYSTEM
K123471 · DZE
Hiossen, Inc.
Dental · 234d
Cleared Jul 05, 2013
AIRVIEW BOWIE DICK
K130211 · JOJ
Spsmedical Supply Corp.
General Hospital · 157d
Cleared Jul 05, 2013
TIBURON SURGICAL DRAPE
K130404 · KKX
Cardinal Health200, LLC
General Hospital · 136d
Cleared Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · LZA
Hartalega Sdn Bhd
General Hospital · 133d
Cleared Jul 05, 2013
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · MED
STERIS Corporation
General Hospital · 79d
Cleared Jul 05, 2013
CLICKFINE AUTOPROTECT PEN NEEDLE
K131123 · FMI
Ypsomed AG
General Hospital · 74d
Cleared Jul 05, 2013
CLICKFINE PEN NEEDLE
K131125 · FMI
Ypsomed AG
General Hospital · 74d
Cleared Jul 05, 2013
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
K131283 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jul 05, 2013
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE...
K131511 · GDW
Changzhou Sinolinks Medical...
General & Plastic Surgery · 38d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599 · GNX
Quidel Corporation
Microbiology · 32d
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606 · GNX
Quidel Corp.
Microbiology · 32d
Cleared Jul 05, 2013
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE...
K131666 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 28d
Cleared Jul 05, 2013
MECTALIF
K131671 · MAX
Medacta International
Orthopedic · 28d
Cleared Jul 03, 2013
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE...
K120977 · GGN
International Technidyne Corp.
Hematology · 457d
Cleared Jul 03, 2013
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 275d
Cleared Jul 03, 2013
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL,...
K123171 · CJY
HORIBA ABX SAS
Chemistry · 267d
Cleared Jul 03, 2013
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
K123177 · ILY
Laserstim, Inc.
Physical Medicine · 267d
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · DEM
The Binding Site Group , Ltd.
Immunology · 258d
Cleared Jul 03, 2013
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL...
K123641 · MQK
Hertart
Obstetrics & Gynecology · 219d
Cleared Jul 03, 2013
FASTPACK VITAMIN D
K123983 · MRG
Qualigen, Inc.
Chemistry · 189d
Cleared Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
K124035 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 187d