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
47257–47280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2011
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
K110640 · NHA
Astra Tech, Inc.
Dental · 98d
Cleared Jun 10, 2011
TEMPOCEM
K110759 · EMB
Dmg USA, Inc.
Dental · 84d
Cleared Jun 10, 2011
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K110936 · MSD
AngioDynamics, Inc.
Gastroenterology & Urology · 67d
Cleared Jun 10, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110969 · LYZ
Ppp Medical and Safety Products...
General Hospital · 65d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · JIT
Abbott Laboratories
Chemistry · 58d
Cleared Jun 10, 2011
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
K111344 · OWB
Infimed, Inc.
Radiology · 29d
Cleared Jun 10, 2011
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K111471 · MBI
Medshape Solutions, Inc.
Orthopedic · 14d
Cleared Jun 09, 2011
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED...
K102496 · MKJ
Cardiac Science Corporation
Cardiovascular · 282d
Cleared Jun 09, 2011
KJ MASK
K103019 · DZB
Kj Meditech Co., Ltd.
Dental · 240d
Cleared Jun 09, 2011
AEROVENT PLUS CHC
K110273 · CAF
Monaghan Medical Corporation
Anesthesiology · 129d
Cleared Jun 09, 2011
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
K110394 · JIX
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 118d
Cleared Jun 09, 2011
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · FMI
Terumo Europe N.V.
General Hospital · 73d
Cleared Jun 09, 2011
SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
K111016 · FPA
Elcam Medical Acal
General Hospital · 58d
Cleared Jun 09, 2011
ATRICURE DISSECTOR
K111020 · FTD
AtriCure, Inc.
General & Plastic Surgery · 58d
Cleared Jun 09, 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · DYB
St Jude Medical
Cardiovascular · 51d
Cleared Jun 09, 2011
ELECSYS SHBG CALCHECK 5
K111349 · JJX
Roche Diagnostics
Chemistry · 27d
Cleared Jun 08, 2011
BIOGRAPH MMR
K103429 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared Jun 08, 2011
ERKA. PERFECT-ANEROID
K103637 · DXQ
Erka Kallmeyer Medizintechnik GmbH
Cardiovascular · 177d
Cleared Jun 08, 2011
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
K103724 · LLZ
Eizo GmbH
Radiology · 169d
Cleared Jun 08, 2011
TSRH SPINAL SYSTEM
K110070 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 149d
Cleared Jun 08, 2011
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH...
K110272 · KGO
Cardinal Health, Inc.
General Hospital · 128d
Cleared Jun 08, 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K110284 · MNI
Medyssey Co, Ltd.
Orthopedic · 127d
Cleared Jun 08, 2011
PACEART OPTIMA SYSTEM SOFTWARE
K110693 · KRE
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jun 08, 2011
IMESH TACKER
K110728 · GDW
Easylap , Ltd.
General & Plastic Surgery · 84d