FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37393–37416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2014
ECLERIS SINUSCOPE
K131323 · EOB
Ecleris USA
Ear, Nose, Throat · 397d
Cleared Jun 09, 2014
AIRSOFT F15
K132901 · BZD
Resmed, Ltd.
Anesthesiology · 266d
Cleared Jun 09, 2014
SENTIERO
K133012 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 09, 2014
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
K140357 · HRS
Orthopaedic Implant Company
Orthopedic · 117d
Cleared Jun 09, 2014
AERO BLUE PERFORMANCE SURGICAL GOWN
K140539 · FYA
Kimberly Clark Corporation
General Hospital · 97d
Cleared Jun 09, 2014
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K140930 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 59d
Cleared Jun 09, 2014
GUARDIAN URETHRAL SHEATH
K141252 · KNY
Solace Therapeutics
Gastroenterology & Urology · 26d
Cleared Jun 06, 2014
HANDHELD MONITOR
K131762 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 354d
Cleared Jun 06, 2014
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K132205 · CAW
Inova Labs, Inc.
Anesthesiology · 325d
Cleared Jun 06, 2014
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
K132415 · BTR
Teleflexmedical, Inc.
Anesthesiology · 308d
Cleared Jun 06, 2014
BIOMONITOR
K132960 · MXD
Biotronik, Inc.
Cardiovascular · 259d
Cleared Jun 06, 2014
ATOVEN
K133774 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 176d
Cleared Jun 06, 2014
CA 125 II CALSET II
K140112 · JIT
Roche Diagnostics
Immunology · 142d
Cleared Jun 06, 2014
STARBAND AND STARLIGHT
K140353 · MVA
Orthomerica Products, Inc.
Neurology · 114d
Cleared Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
K140546 · LDJ
Healgen Scientific, LLC
Chemistry · 94d
Cleared Jun 06, 2014
AXERA 2 ACCESS SYSTEM
K140871 · DYB
Arstasis, Inc.
Cardiovascular · 63d
Cleared Jun 06, 2014
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING...
K140972 · LDF
Medtronic, Inc.
Cardiovascular · 51d
Cleared Jun 06, 2014
ENSITE VELOCITY SYSTEM
K141050 · DQK
St Jude Medical
Cardiovascular · 44d
Cleared Jun 06, 2014
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
K141060 · PAW
On-X Life Technologies, Inc.
Cardiovascular · 43d
Cleared Jun 06, 2014
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · DQK
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 06, 2014
DR 400
K141192 · MQB
Agfa Healthcare N.V.
Radiology · 29d
Cleared Jun 05, 2014
ALADDIN
K131567 · HJO
Visia Imaging S.R.L.
Ophthalmic · 371d
Cleared Jun 05, 2014
U FIT DENTAL IMPLANT SYSTEM
K132956 · DZE
T Strong, Inc.
Dental · 258d
Cleared Jun 05, 2014
ENDOWRIST VESSEL SEALER
K140189 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 132d