FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
170089–170112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1978
EXTUBE
K781728 · KEA
Analytichem International, Inc.
Toxicology · 75d
Cleared Dec 20, 1978
RIA KIT, PREG-STAT
K781733 · JHI
Serono Laboratories, Inc.
Immunology · 68d
Cleared Dec 20, 1978
HUMIDIFIERS, MODEL:LS-420 AND LS-460
K781760 · BTT
Bourns Medical Systems, Inc.
Anesthesiology · 65d
Cleared Dec 20, 1978
COMPRESSION HIP SCREW SYSTEM
K781762 · KTW
Howmedica Corp.
Orthopedic · 65d
Cleared Dec 20, 1978
DETECTOR, MODEL 79875A, VARIABLE
K781771 · KIE
Hewlett-Packard Co.
Toxicology · 68d
Cleared Dec 20, 1978
ABRASIVE WHEELS
K781777 · EJQ
Dentsply Intl.
Dental · 68d
Cleared Dec 20, 1978
ISOPLAST
K781787 · EBF
Vivadent (Usa), Inc.
Dental · 62d
Cleared Dec 20, 1978
WASHER SYSTEM, MICROELISA
K781802 · JTC
Metrix Teknika, Inc.
Chemistry · 58d
Cleared Dec 20, 1978
ELECTROSURGICAL UNIT 3001-3009
K781810 · GEI
Neomed Corp.
General & Plastic Surgery · 55d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE A
K781862 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
MYCOPLASMA ARGININI FITC (30-403-41)
K781874 · KPB
Flow Laboratories, Inc.
Pathology · 47d
Cleared Dec 20, 1978
STAIN KIT FOR CELL CULTURES (30-100-00)
K781875 · KPB
Flow Laboratories, Inc.
Pathology · 47d
Cleared Dec 20, 1978
SERUM, CREATININE DETERMINATIONS
K781884 · CGX
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
SERUM, BLOOD UREA NITIOGEN
K781885 · CDW
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · JJY
Sigma Chemical Co.
Chemistry · 42d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE B
K781895 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE A,B
K781896 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
CLEARING SOLUTION #ECA01976
K781898 · JQK
Electrophoresis Corp. of America
Chemistry · 37d
Cleared Dec 20, 1978
UREA NITROGEN TEST
K781899 · CDL
Wako Intl., Inc.
Chemistry · 37d
Cleared Dec 20, 1978
ANALYZER, AUTOMED CENTRIFUGAL
K781900 · JJG
Autogenic Systems
Chemistry · 37d
Cleared Dec 20, 1978
HUMAN II LENS
K781927 · HQG
Spectra-Shield, Inc.
Ophthalmic · 34d
Cleared Dec 20, 1978
NU-GLAZE
K781935 · ELL
Deringer-Ney, Inc.
Dental · 30d
Cleared Dec 20, 1978
COLUMN TEST, HEMOGLOBIN A
K781948 · LCP
Bio-Rad
Hematology · 29d
Cleared Dec 20, 1978
DIJI-DENT
K781962 · EFW
J&J Technologies, Inc.
Dental · 29d