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
52249–52272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2009
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER...
K091553 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 117d
Cleared Sep 21, 2009
INJECTAFIL
K091647 · EBF
Apex Dental Materials, Inc.
Dental · 104d
Cleared Sep 21, 2009
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008,...
K091853 · BZK
Nspire Health, Inc.
Anesthesiology · 90d
Cleared Sep 21, 2009
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870 · MBI
Tornier
Orthopedic · 90d
Cleared Sep 21, 2009
T2 SPINAL SYSTEM
K091883 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Sep 21, 2009
POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
K091942 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 83d
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY...
K092051 · JJY
Microgenics Corp.
Chemistry · 76d
Cleared Sep 21, 2009
RASCAL WE GO 250 POWERED WHEELCHAIR
K092130 · ITI
Electric Mobility Corp.
Physical Medicine · 68d
Cleared Sep 21, 2009
HEARTWAY POWER MOBILITY SCOOTER, S9
K092154 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 67d
Cleared Sep 21, 2009
HEARTWAY POWER MOBILITY SCOOTER, S8
K092155 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 67d
Cleared Sep 21, 2009
MICRO-TOUCH NITRA FREE
K092327 · LZA
Ansell Healthcare Products, LLC
General Hospital · 48d
Cleared Sep 21, 2009
X-CUBE
K092758 · EBW
Saeshin Precision Co., Ltd.
Dental · 12d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118 · NPQ
Cepheid
Pathology · 417d
Cleared Sep 18, 2009
COLLAGEN DENTAL MEMBRANE IV
K090216 · NPL
Collagen Matrix, Inc.
Dental · 232d
Cleared Sep 18, 2009
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · MQK
Thermo Fisher Scientific (Nalge Nunc...
Obstetrics & Gynecology · 211d
Cleared Sep 18, 2009
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
K090449 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Sep 18, 2009
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
K090450 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Sep 18, 2009
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
K090742 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 182d
Cleared Sep 18, 2009
CFI ULTRASOUND PROBE DRAPE
K090773 · IYO
Contour Fabricators, Inc.
Radiology · 179d
Cleared Sep 18, 2009
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · GKZ
Microgenics Corp.
Hematology · 177d
Cleared Sep 18, 2009
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
K090855 · MQV
Etex Corp.
Orthopedic · 172d
Cleared Sep 18, 2009
DIANA FUSION CAGE
K091122 · MAX
Signus Medical
Orthopedic · 154d
Cleared Sep 18, 2009
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268 · DQE
Hospira, Inc.
Cardiovascular · 141d
Cleared Sep 18, 2009
LIGHTLAS MODEL 532
K091534 · HQF
Lightmed Corp.
Ophthalmic · 115d