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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59905–59928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2007
ASC-12 PIEZOELECTRIC SCALER
K070866 · ELC
Aseptico, Inc.
Dental · 13d
Cleared Apr 11, 2007
POD B-SCAN
K070884 · IYO
Starfish Product Engineering, Inc.
Radiology · 12d
Cleared Apr 10, 2007
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
K063542 · FLL
Mesure Technology Co., Ltd.
General Hospital · 137d
Cleared Apr 10, 2007
JMS PLANECTA STOPCOCK
K070143 · FMG
Jms North America Corp.
General Hospital · 84d
Cleared Apr 10, 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · KWP
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Apr 10, 2007
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
K070519 · LYZ
Zhang Jia Gang Huayuan Plastic Co. ,...
General Hospital · 47d
Cleared Apr 10, 2007
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K070813 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Apr 10, 2007
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
K070850 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 13d
Cleared Apr 09, 2007
POWERED NITRILE BLUE EXAMINATION GLOVES
K061505 · LZA
Liwe Trading
General Hospital · 312d
Cleared Apr 09, 2007
FOAM RING PORT PROTECTOR
K062261 · OBK
Inspired Ideas, Incorporated
General Hospital · 248d
Cleared Apr 09, 2007
RMI LCD ALCOHOL DETECTOR
K062545 · DJZ
Resource Management International, LLC
Toxicology · 222d
Cleared Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS,...
K063720 · DHA
Ortho-Clinical Diagnostics
Chemistry · 115d
Cleared Apr 09, 2007
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K070641 · NBW
Taidoc Technology Corporation
Chemistry · 32d
Cleared Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL,...
K070734 · LCP
Diazyme Laboratories
Chemistry · 24d
Cleared Apr 06, 2007
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K061812 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 06, 2007
COMBI SCAN100
K061846 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 06, 2007
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · KNK
Olympus America, Inc.
Chemistry · 193d
Cleared Apr 06, 2007
KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
K063501 · BZD
Mallinckrodt Developpement France
Anesthesiology · 137d
Cleared Apr 06, 2007
KINESIA
K063872 · GYD
Cleveland Medical Devices, Inc.
Neurology · 98d
Cleared Apr 06, 2007
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
K070051 · DQY
Acumen Medical, Inc.
Cardiovascular · 92d
Cleared Apr 06, 2007
STRADA CAROTID GUIDING SHEATH
K070166 · DYB
St Jude Medical
Cardiovascular · 78d
Cleared Apr 06, 2007
VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)
K070218 · MQP
Vertiflex (Tm), Incorporated
Orthopedic · 73d
Cleared Apr 06, 2007
HYPERQ SYSTEM
K070624 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 31d
Cleared Apr 06, 2007
OPUS SMARTSTITCH SUTURE DEVICE
K070671 · OCW
Arthrocare Corp.
Gastroenterology & Urology · 25d