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
61657–61680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2006
CRYSTALVIEW R200
K062390 · MQB
Alara, Inc.
Radiology · 33d
Cleared Sep 18, 2006
DIGI-LITE TCD DEVICE
K062578 · IYN
Rimed , Ltd.
Radiology · 18d
Cleared Sep 18, 2006
POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K062655 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 11d
Cleared Sep 15, 2006
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
K060681 · JXG
Medtronic Neurosurgery
Neurology · 184d
Cleared Sep 15, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND...
K060770 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 177d
Cleared Sep 15, 2006
NUTRISAFE 2
K060944 · FPD
Vygon Corp.
Gastroenterology & Urology · 162d
Cleared Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190 · CEW
Beckman Coulter, Inc.
Chemistry · 140d
Cleared Sep 15, 2006
MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
K061502 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 107d
Cleared Sep 15, 2006
FUSION
K061557 · DXN
Medwave, Inc.
Cardiovascular · 102d
Cleared Sep 15, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K061659 · LYZ
Tangshan Luxiong Plastic Products...
General Hospital · 95d
Cleared Sep 15, 2006
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K061662 · LYZ
Tangshan Luxiong Plastic Products...
General Hospital · 95d
Cleared Sep 15, 2006
PULSERA
K061685 · IZL
Philips Medical Systems North America...
Radiology · 92d
Cleared Sep 15, 2006
SURGICAL HEADLIGHT
K061690 · FST
Gulf Medical Fiberoptics
General & Plastic Surgery · 92d
Cleared Sep 15, 2006
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · DQK
Ge Healthcare
Cardiovascular · 87d
Cleared Sep 15, 2006
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Sep 15, 2006
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
K061780 · DXH
Rozinn Electronics, Inc.
Cardiovascular · 81d
Cleared Sep 15, 2006
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · FXX
Dukal Corp.
General Hospital · 74d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974 · CHL
Instrumentation Laboratory CO
Chemistry · 65d
Cleared Sep 15, 2006
PREVU POINT OF CARE SKIN STEROL TEST
K062092 · LBS
Premd, Inc.
Chemistry · 53d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216 · HRS
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Sep 15, 2006
AESCULAP NEURO PATTIES
K062406 · HBA
Aesculap, Inc.
Neurology · 29d
Cleared Sep 15, 2006
XPLORER 1100
K062417 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Sep 15, 2006
LIFECATH S PICC AND MIDLINE CATHETER
K062425 · LJS
Vygon Corp.
General Hospital · 28d