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
72337–72360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · HWC
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 86d
Cleared Jun 26, 2003
TS3 TUBING SET
K031151 · DWF
Global Blood Resources, LLC
Cardiovascular · 77d
Cleared Jun 26, 2003
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE...
K031414 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 52d
Cleared Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND...
K031591 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 36d
Cleared Jun 26, 2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
K031622 · MQE
Portex , Ltd.
Obstetrics & Gynecology · 34d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Jun 25, 2003
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
K014013 · FLF
H & W Technology, LLC
General Hospital · 567d
Cleared Jun 25, 2003
DETECTAR, MODEL N123-MI
K023367 · EJB
Neks Technologies
Dental · 260d
Cleared Jun 25, 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K023817 · MNW
Clio Designs, Inc.
Gastroenterology & Urology · 222d
Cleared Jun 25, 2003
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · JFY
Diametrics Medical, Inc.
Chemistry · 173d
Cleared Jun 25, 2003
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
K030708 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 111d
Cleared Jun 25, 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · CAH
Datex-Ohmeda
General Hospital · 89d
Cleared Jun 25, 2003
MIRACLE 98
K031010 · EJT
Sb Lucius, Inc.
Dental · 86d
Cleared Jun 25, 2003
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159 · JIT
Diamond Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450 · LLL
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 25, 2003
RAPIDO CUT-AWAY GUIDING CATHETER
K031505 · DQY
Guidant Corporation
Cardiovascular · 42d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644 · JJY
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682 · JIX
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX
Datex-Ohmeda
Cardiovascular · 15d
Cleared Jun 24, 2003
ASYRA
K023355 · GZO
Galloway Technologies, LLC
Neurology · 260d