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

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176,076 results
68833–68856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · DJG
Microgenics Corp.
Toxicology · 135d
Cleared Jun 23, 2004
ACCUSOFT
K040474 · MUJ
Direx Systems Corp.
Radiology · 120d
Cleared Jun 23, 2004
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494 · NEZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 118d
Cleared Jun 23, 2004
AESKULISA ANA HEP-2
K040953 · LJM
Aesku, Inc.
Immunology · 72d
Cleared Jun 23, 2004
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · HKI
Canon, Inc.
Ophthalmic · 14d
Cleared Jun 23, 2004
AUTODETECT SYRINGE
K041590 · FMF
Indigo Orb, Inc.
General Hospital · 9d
Cleared Jun 22, 2004
POWDERED LATEX SURGEON'S GLOVES
K031368 · KGO
Cephas Medical Private , Ltd.
General Hospital · 419d
Cleared Jun 22, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 235d
Cleared Jun 22, 2004
SOFTSEAL HSG CATHETER
K040238 · LKF
Modern Medical Equipment Mfg., Ltd.
Obstetrics & Gynecology · 148d
Cleared Jun 22, 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
K040817 · HIB
Advanced Urological Developments
Obstetrics & Gynecology · 84d
Cleared Jun 22, 2004
QBTEST
K040894 · LQD
Qbtech AB
Neurology · 77d
Cleared Jun 22, 2004
VITALHEAT
K040911 · DWJ
Dynatherm Medical, Inc.
Cardiovascular · 75d
Cleared Jun 22, 2004
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
K041108 · MPA
Iscience Surgical Corporation
Ophthalmic · 55d
Cleared Jun 22, 2004
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
K041369 · HAW
Orthosoft, Inc.
Neurology · 29d
Cleared Jun 22, 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · GXQ
Codman & Shurtleff, Inc.
Neurology · 15d
Cleared Jun 22, 2004
VOLUME VIEWER PLUS
K041521 · JAK
General Electric Medical Systems
Radiology · 14d
Cleared Jun 22, 2004
GE DISCOVERY ST
K041543 · KPS
Ge Healthcare
Radiology · 14d
Cleared Jun 22, 2004
COMPACS, VERSION 1.0
K041581 · LLZ
Intelligent Images Srl
Radiology · 8d
Cleared Jun 21, 2004
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · GXN
Synthes (Usa)
Neurology · 192d
Cleared Jun 21, 2004
THERMAGE THERMACOOL SYSTEM
K040135 · GEI
Thermage, Inc.
General & Plastic Surgery · 151d
Cleared Jun 21, 2004
MEDICINAL LEECHES
K040187 · NRN
North America BioPharma
General & Plastic Surgery · 145d
Cleared Jun 21, 2004
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K040413 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 124d
Cleared Jun 21, 2004
CONCENTRIC RETRIEVER X5, MODEL 90035
K040700 · DQY
Concentric Medical, Inc.
Cardiovascular · 96d
Cleared Jun 21, 2004
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
K040853 · LBI
International Hospital Supply Co.
General Hospital · 81d