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
75337–75360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2002
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K022548 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 14d
Cleared Aug 15, 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 10d
Cleared Aug 14, 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · NLH
Sterilmed, Inc.
Cardiovascular · 373d
Cleared Aug 14, 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · NLH
Sterilmed, Inc.
Cardiovascular · 365d
Cleared Aug 14, 2002
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
K013038 · DTZ
Polystan A/S
Cardiovascular · 338d
Cleared Aug 14, 2002
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K013618 · MQN
Osteomed Corp.
Dental · 282d
Cleared Aug 14, 2002
DASH 3000/4000 PATIENT MONITOR
K020290 · MHX
General Electric Medical Systems...
Cardiovascular · 198d
Cleared Aug 14, 2002
SERRALGUT
K020597 · GAL
Serral, S.A. DE C.V.
General & Plastic Surgery · 173d
Cleared Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · GKR
Biotest Medizintechnik GmbH
Hematology · 162d
Cleared Aug 14, 2002
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
K020984 · MKJ
Access Cardiosystems, Inc.
Cardiovascular · 149d
Cleared Aug 14, 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Aug 14, 2002
SYNTHES CRANIOFACIAL PLATES
K021642 · JEY
Synthes (Usa)
Dental · 86d
Cleared Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER,...
K021707 · KNW
Senorx, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
K021792 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 75d
Cleared Aug 14, 2002
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
K021808 · FZP
Weck
General & Plastic Surgery · 72d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · FGE
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Aug 14, 2002
MAEDA SILVER ACUPUNCTURE NEEDLE
K021904 · MQX
Maeda Toyokichi Shoten
General Hospital · 65d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Cook, Inc.
Anesthesiology · 64d
Cleared Aug 14, 2002
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · LKO
Rhigene, Inc.
Immunology · 55d
Cleared Aug 14, 2002
REGISTRADO X-TRA
K022066 · ELW
Voco GmbH
Dental · 50d
Cleared Aug 14, 2002
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K022242 · DSY
Intervascular
Cardiovascular · 34d
Cleared Aug 14, 2002
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K022270 · ODA
Olympus Optical Co., Ltd.
Radiology · 30d
Cleared Aug 14, 2002
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
K022414 · HAW
Medtronic Surgical Navigation...
Neurology · 21d
Cleared Aug 14, 2002
SCREWLINE
K022425 · DZE
Altatec Biotechnologies N.A., Inc.
Dental · 21d