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
30697–30720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2016
Lipogems System
K161636 · MUU
Lipogems International Spa
General & Plastic Surgery · 143d
Cleared Nov 04, 2016
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
K161646 · CGN
Diazyme Laboratories
Chemistry · 142d
Cleared Nov 04, 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703 · HRS
Aap Implantate AG
Orthopedic · 137d
Cleared Nov 04, 2016
D-SPECT Scanner, D-SPECT L Scanner
K161740 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 133d
Cleared Nov 04, 2016
AOS Small Fragment Plating System
K161913 · HRS
Advanced Orthopaedic Solutions, Inc....
Orthopedic · 115d
Cleared Nov 04, 2016
SwiftNINJA Microcatheter
K161921 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Nov 04, 2016
Avance Foam Dressing Kit - XL
K161935 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 113d
Cleared Nov 04, 2016
Barrier Supreme Sterilization Wrapper
K162162 · FRG
Standard Textile Co., Inc.
General Hospital · 94d
Cleared Nov 04, 2016
Puritan Fecal Opti-Swab Collection and Transport System
K162284 · JSM
Puritan Medical Products, LLC
Microbiology · 81d
Cleared Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
K162350 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Nov 04, 2016
CardioInsight Cardiac Mapping System
K162440 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 65d
Cleared Nov 04, 2016
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy...
K162573 · KXK
Source Production and Equipment Co.,...
Radiology · 50d
Cleared Nov 04, 2016
SuniIQ Digital Radiography System
K162585 · MUH
Suni Medical Imaging, Inc.
Radiology · 49d
Cleared Nov 04, 2016
Trex_HD
K162595 · GWQ
Natus Medical Incorporated Dba...
Neurology · 50d
Cleared Nov 04, 2016
I View and Imagen Sensor
K162619 · MUH
Trident S.R.L
Radiology · 45d
Cleared Nov 04, 2016
Pinpoint GT Introducer Needle
K162769 · DYB
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Nov 03, 2016
Vonflex S
K152615 · ELW
Vericom Co., Ltd.
Dental · 416d
Cleared Nov 03, 2016
Intermittent Pneumatic Compression system
K160180 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 281d
Cleared Nov 03, 2016
Electronic Sphygmomanometer
K160349 · DXN
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 269d
Cleared Nov 03, 2016
PleurX Peritoneal Catheter System
K160437 · PNG
Care Fusion
Gastroenterology & Urology · 260d
Cleared Nov 03, 2016
Greiner Holdex
K160532 · FMI
Greiner Bio-One Na, Inc.
General Hospital · 251d
Cleared Nov 03, 2016
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS...
K160921 · PSW
Cs Medical, LLC
General Hospital · 213d
Cleared Nov 03, 2016
FONA Pan/Ceph
K161131 · MUH
Fona S.R.L
Radiology · 196d
Cleared Nov 03, 2016
Vitrea CT Dual Energy Image View
K161157 · JAK
Vital Images, Inc.
Radiology · 192d