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
55633–55656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494 · MQB
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Sep 11, 2008
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
K071455 · MKW
Siemens Medical Solutions Diagnostics
Toxicology · 475d
Cleared Sep 11, 2008
PARKONE
K073508 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 273d
Cleared Sep 11, 2008
EFFECTIV (TM) CAP
K080579 · QBP
Hospira, Inc.
General Hospital · 192d
Cleared Sep 11, 2008
HLM TUBING SET WITH BIOLINE COATING
K080592 · DWE
Maquet Cardiopulmonary, AG
Cardiovascular · 192d
Cleared Sep 11, 2008
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
K080682 · EFB
Handpiece Headquarters, Inc. - Hpr, Inc.
Dental · 185d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Abbott Laboratories
Toxicology · 183d
Cleared Sep 11, 2008
ARCHITECT CYCLOSPORINE
K080751 · MKW
Fujirebio Diagnostics,Inc.
Toxicology · 177d
Cleared Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
K081338 · NHX
Roche Diagnostics
Immunology · 121d
Cleared Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
K081450 · NBW
Bionime Corporation
Chemistry · 111d
Cleared Sep 11, 2008
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K081523 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 101d
Cleared Sep 11, 2008
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
K081693 · BXR
Instrumentation Industries, Inc.
Anesthesiology · 86d
Cleared Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
K081704 · GEX
Lumenis, Inc.
Ophthalmic · 86d
Cleared Sep 11, 2008
LUCENT MAGNUM+
K081711 · OVD
Spinal Elements, Inc.
Orthopedic · 86d
Cleared Sep 11, 2008
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
K082073 · MQV
Apatech , Ltd.
Orthopedic · 50d
Cleared Sep 11, 2008
EYEFEEL OPHTHALMIC WARMER
K082087 · IMD
Bio-Lipid, Inc.
Physical Medicine · 50d
Cleared Sep 11, 2008
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
K082307 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 29d
Cleared Sep 11, 2008
VASCUTRAK 2, MODELS: V14 AND V18
K082343 · PNO
Ymed, Inc.
Cardiovascular · 27d
Cleared Sep 11, 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · LPL
Unilens Corp., USA
Ophthalmic · 23d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
St Jude Medical
Cardiovascular · 15d
Cleared Sep 10, 2008
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
K080775 · HEB
Tosama D.D.
Obstetrics & Gynecology · 175d
Cleared Sep 10, 2008
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
K081557 · IXA
Jddb Manufacturing, Inc.
Radiology · 99d
Cleared Sep 10, 2008
BEAMER ARGON PROBE
K081644 · GEI
Conmed Corporation
General & Plastic Surgery · 90d
Cleared Sep 10, 2008
VISUALASE THERMAL THERAPY SYSTEM
K081656 · LLZ
Biotex, Inc.
Radiology · 90d