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
169465–169488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1979
MODEL 114 TREONIC H150 HAEMOHEATER
K790936 · KZL
Vickers America Medical Corp.
Hematology · 109d
Cleared Sep 04, 1979
VITREOUS SUCTION/CUTTER
K791000 · HKP
Concept, Inc.
Ophthalmic · 98d
Cleared Sep 04, 1979
DENTAL XERORADIOGRAPHY
K791014 · EAP
Xerox Medical Systems
Radiology · 95d
Cleared Sep 04, 1979
FETASONDE FETAL ACTIVITY MONITOR
K791035 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE UTERINE WORK MONITOR
K791036 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE LABOR STATUS DISPLAY
K791037 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE UTERINE ACTIVITY MONITOR
K791038 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE FETAL HEART RATE VARIABILITY
K791039 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
HEMATRAK ABNORMAL RECOGNITION
K791041 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 91d
Cleared Sep 04, 1979
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
K791066 · CGA
Fermco Biochemics, Inc.
Chemistry · 84d
Cleared Sep 04, 1979
BILI-DOSIMETER
K791114 · LBI
Olympic Medical Corp.
General Hospital · 81d
Cleared Sep 04, 1979
PSORALITE SERIES 30,000
K791116 · KGL
Paul B. Elder Co.
General & Plastic Surgery · 81d
Cleared Sep 04, 1979
FLU-VEN TK-2
K791130 · KSB
Venospital, Inc.
Hematology · 78d
Cleared Sep 04, 1979
FLU VEN TR-1
K791131 · KSB
Venospital, Inc.
Hematology · 78d
Cleared Sep 04, 1979
GELSKIN
K791162 · ILO
Spenco Medical Corp.
Physical Medicine · 71d
Cleared Sep 04, 1979
TSH RIA KIT
K791217 · JLW
Antibodies, Inc.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T4
K791231 · CDX
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T3
K791232 · CDP
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
FIBRO-TEC TEST KIT
K791358 · GHH
Calbiochem-Behring Corp.
Hematology · 42d
Cleared Sep 04, 1979
KODAK ORTHO M FILM
K791360 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Sep 04, 1979
ELECTROSURGICAL CUT AND COAGU ACCESSORY
K791362 · GEI
Intermedics, Inc.
General & Plastic Surgery · 56d
Cleared Sep 04, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared Sep 04, 1979
SIMMONS CITRATE AGAR
K791474 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 39d
Cleared Sep 04, 1979
HEKTOEN ENTERIC AGAR
K791475 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 39d