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
169249–169272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1979
PTH RIA 200
K791128 · CEW
Institut National Des Radioelements
Chemistry · 101d
Cleared Sep 27, 1979
DIAGNOSTIC ULTRASOUND SYSTEM
K791298 · IYO
Xonics Medical Systems, Inc.
Radiology · 73d
Cleared Sep 27, 1979
FAST FLOW #60310
K791365 · LCP
Hi Chem, Inc.
Hematology · 64d
Cleared Sep 27, 1979
TECHNICON STAR SYSTEM
K791549 · DON
Technicon Instruments Corp.
Toxicology · 45d
Cleared Sep 27, 1979
CAMPYLOBACTER SELECTIVE MEDIUM
K791578 · JSJ
Anaerobe Systems
Microbiology · 41d
Cleared Sep 27, 1979
VENTRE/SEP T3 TEST SET
K791588 · CDP
Ventrex Laboratories, Inc.
Chemistry · 41d
Cleared Sep 27, 1979
TRYPTIC SOY BROTH
K791623 · JSC
American Laboratory Supply, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
MYCOBIOTIC AGAR
K791626 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
MANNITOL SALT AGAR
K791627 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD
K791628 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART CC AGAR
K791629 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART INFUSION AGAR
K791630 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
SABOURAUD DEXTROSE AGAR
K791631 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
TOTAL ESTROGENS KIT BY RIA
K791651 · JMD
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
ESTRADIOL KIT BY RIA
K791652 · CHP
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT BINDING
K791662 · KHQ
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791664 · CDX
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
ARCOLITH 2000
K791715 · DXY
Arco Medical Products Co.
Cardiovascular · 27d
Cleared Sep 27, 1979
IMPLANTABLE VENTRICULAR-INHIBITED
K791727 · DXY
Telectronics, Inc.
Cardiovascular · 27d
Cleared Sep 27, 1979
RSL'S ASSAY PROCEDURE QUANTITATION
K791728 · CGI
Radioassay Systems Laboratories, Inc.
Chemistry · 28d
Cleared Sep 27, 1979
SERUM 11-DESOXYCORTISOL I AS TRACER
K791740 · JKB
Radioassay Systems Laboratories, Inc.
Chemistry · 17d
Cleared Sep 27, 1979
URIC ACID REAGENT
K791754 · KNK
Gilford Diagnostics
Chemistry · 22d
Cleared Sep 27, 1979
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760 · CFR
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 27, 1979
COMP-ACT IV
K791795 · DPS
Medcraft Corp.
Cardiovascular · 13d