FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68953–68976 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2004
ESPRIT VENTILATOR, MODEL V1000
K034040 · CBK
Respironics, Inc.
Anesthesiology · 23d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · JHX
Diagnostic Products Corp.
Chemistry · 22d
Cleared Jan 21, 2004
MODIFICATION TO PRISMALIX SURGICAL LIGHT
K040015 · FSY
Alm S.A.
General & Plastic Surgery · 16d
Cleared Jan 20, 2004
GII SPINAL FIXATION SYSTEM
K032604 · MNH
Co-Ligne AG
Orthopedic · 148d
Cleared Jan 20, 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 146d
Cleared Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · HKX
Reichert, Inc.
Ophthalmic · 133d
Cleared Jan 20, 2004
SPHINX LASER SYSTEMS
K033437 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 84d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · KTT
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 20, 2004
MRJ
K033507 · LNH
Paramed S.R.L.
Radiology · 76d
Cleared Jan 20, 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K033744 · MVM
Hycor Biomedical , Ltd.
Immunology · 50d
Cleared Jan 20, 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · DKZ
Varian, Inc.
Toxicology · 34d
Cleared Jan 20, 2004
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
K033956 · KPS
Is2 Research, Inc.
Radiology · 29d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Jan 16, 2004
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
K030341 · CBK
eVent Medical, Ltd.
Anesthesiology · 347d
Cleared Jan 16, 2004
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
K031617 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 238d
Cleared Jan 16, 2004
DUREX PLAY LUBRICANT
K032124 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 190d
Cleared Jan 16, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · HBE
Stryker Instruments
Neurology · 175d
Cleared Jan 16, 2004
LUXAFORM PLUS
K033227 · EBG
Dmg USA, Inc.
Dental · 102d
Cleared Jan 16, 2004
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K033328 · DTL
Novosci Corp.
Cardiovascular · 92d
Cleared Jan 16, 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · GEX
Candela Corp.
General & Plastic Surgery · 92d
Cleared Jan 16, 2004
LIGAND PLUS CONTROL LEVEL 1-3
K033344 · JJY
Consolidated Technology
Chemistry · 88d
Cleared Jan 16, 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · HSX
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 16, 2004
CANDELA VBEAM PULSE DYE LASER SYSTEM
K033461 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jan 16, 2004
BISBLOCK
K033521 · EJK
Bisco, Inc.
Dental · 70d