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

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175,820 results
40657–40680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2013
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
K130345 · NUC
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 171d
Cleared Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM,...
K130814 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Aug 01, 2013
PASSPORT ROBOTIC REDUCER CAP
K130826 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 128d
Cleared Aug 01, 2013
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
K131079 · DYB
Creganna Medical Devices
Cardiovascular · 106d
Cleared Aug 01, 2013
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
K131305 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 86d
Cleared Jul 31, 2013
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K123908 · KKY
Matrix Surgical USA
General & Plastic Surgery · 224d
Cleared Jul 31, 2013
ABL90 FLEX
K130144 · CHL
Radiometer Medical Aps
Chemistry · 190d
Cleared Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE...
K130181 · NBW
Infopia Co, Ltd.
Chemistry · 187d
Cleared Jul 31, 2013
5F DIGNITY CT TITANIUM PORT
K130923 · LJT
Medical Components, Inc.
General Hospital · 119d
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729 · OIH
Biofire Diagnostics, Inc.
Microbiology · 49d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 47d
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936 · OEH
Biofire Diagnostics, Inc.
Microbiology · 34d
Cleared Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942 · LJS
Navilyst Medical, Inc.
General Hospital · 34d
Cleared Jul 31, 2013
VIAL CONNECTOR 13MM CLOSED COLLAR
K132040 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 29d
Cleared Jul 31, 2013
REXTAR X
K132041 · EHD
Meta Biomed, Inc.
Radiology · 29d
Cleared Jul 31, 2013
ARTHREX SPEEDCINCH
K132043 · GAT
Arthrex, Inc.
General & Plastic Surgery · 29d
Cleared Jul 30, 2013
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
K122458 · DRG
Cello Partnership D/B/A Verizon Wireless
Cardiovascular · 351d
Cleared Jul 30, 2013
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
K122532 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 344d
Cleared Jul 30, 2013
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
K124000 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 216d
Cleared Jul 30, 2013
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM,...
K130302 · MNI
Spinevision S.A.
Orthopedic · 173d
Cleared Jul 30, 2013
BROADMASTER HEALTHCARE SYSTEM
K130621 · NBW
Broadmaster Biotech Corporation
Chemistry · 144d
Cleared Jul 30, 2013
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
K130949 · DZE
Biomet 3i
Dental · 116d
Cleared Jul 30, 2013
CURA COMPENSATOR
K131150 · IXI
Cura Medical Technologies, LLC
Radiology · 98d
Cleared Jul 30, 2013
COALITION SPACER
K131449 · OVE
Globus Medical, Inc.
Orthopedic · 71d