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
46561–46584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2011
WONDFO METHADONE URINE TEST,OPIATE TEST
K112310 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Sep 08, 2011
OMNI PATIENT MONITOR
K112329 · MWI
Infinium Medical
Cardiovascular · 27d
Cleared Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
K112386 · OTP
Coloplast Corp.
Obstetrics & Gynecology · 21d
Cleared Sep 07, 2011
CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · QSY
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 338d
Cleared Sep 07, 2011
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
K110637 · LFR
Cilag GmbH International
Chemistry · 187d
Cleared Sep 07, 2011
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
K111666 · EBG
Neodental Chemical Products Co., Ltd.
Dental · 85d
Cleared Sep 07, 2011
OPAL BAND CEMENT
K111696 · DYH
Ultradent Products, Inc.
Dental · 82d
Cleared Sep 07, 2011
PILOT SPINAL SYSTEM
K111729 · NKB
Life Spine, Inc.
Orthopedic · 79d
Cleared Sep 07, 2011
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD...
K112272 · LFR
Eps Bio Technology Corp.
Chemistry · 30d
Cleared Sep 07, 2011
UNITE BIOMATRIX
K112399 · KGN
Synovis Orthopedic & Woundcare
General & Plastic Surgery · 19d
Cleared Sep 06, 2011
NM-7000
K111329 · JFB
Nuga Medical Co., Ltd.
Physical Medicine · 118d
Cleared Sep 06, 2011
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR,...
K111472 · LPH
Tgm Medical
Orthopedic · 102d
Cleared Sep 06, 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN...
K111650 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 85d
Cleared Sep 06, 2011
MYSAFETY SYRINGE
K111734 · MEG
Medicalchain Intl. Corp.
General Hospital · 77d
Cleared Sep 06, 2011
FULL CORE BIOPSY SYSTEM
K111765 · KNW
Promex Technologies, LLC
Gastroenterology & Urology · 75d
Cleared Sep 06, 2011
XTRA
K112245 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 33d
Cleared Sep 06, 2011
CERALAS 980NM DIODE LASER FAMILY
K112324 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 25d
Cleared Sep 02, 2011
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE...
K101631 · NBW
Taidoc Technology Corporation
Chemistry · 449d
Cleared Sep 02, 2011
GEM-TONE BODY TRAINING SYSTEM
K102933 · NGX
Gemore Technology Co, Ltd.
Physical Medicine · 333d
Cleared Sep 02, 2011
PROSIM 4, PROSIM 6, PROSIM 8
K110429 · DRT
Fluke Biomedical
Cardiovascular · 199d
Cleared Sep 02, 2011
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · KWT
Zimmer, Inc.
Orthopedic · 165d
Cleared Sep 02, 2011
COMP A-I-R
K110860 · CAF
Omron Healthcare, Inc.
Anesthesiology · 157d
Cleared Sep 02, 2011
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES,...
K111139 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 133d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K111682 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 79d